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We are very transparent in our work and prefer a model in which our client knows everything about the project.
MOST
Reliable CROs to Watch in
2021 September Issue: 10 2021
The Right Insight The Importance of CRO in the Biotechnology Industry
#FutureTech Tracing the Evolu on of Medical Technology
Clinical Research Excellence Built on the Foundations of Quality
Rewriting Healthcare Solutions ealth will remain a major concern until there is life on earth, and healthcare providers will be on their toes to deliver optimal results. In addition, with drastic changes in lifestyles, environmental conditions, and increasing population, there is a rise in the number of rare diseases and diverse disease conditions. All these call for clinical trials and drug development.
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Graduating from clinical trials and lab services to data analytics, drug development, and enhancement, CROs have come a long way. The penetration of technology has eased their work and has provided accuracy in their results. They use the latest technologies like AI, big data, cloud-based trial tracking, and others to improve their research and analysis.
Pharmaceutical companies are always on their toes given the mammoth task of researching and developing drugs. Here is where Contract Research Organizations (CROs) come into the picture bringing significant results to pharma and biotech companies by acting as a catalyst for drug development.
The CRO market is becoming highly competitive. Many large CROs opt for acquisitions and mergers. On the other hand, Smaller CROs are becoming popular due to their personalized approach and cost-effectiveness. The market belongs to those who can swim with the tide and yet stand apart.
The CRO industry is snowballing, particularly with the recent global health concerns. The COVID-19 pandemic has only accelerated the need and growth of CROs, which mandated research and clinical trials. The CROs conduct research and clinical trials for pharmaceutical companies. They deliver results efficiently. In addition, an increase in rare diseases and pandemics gave rise to the demand for research and drug development and consequently to CROs. Pharmaceutical companies are ready to spend for R&D and are outsourcing the job to CROs.
Choosing a CRO is vital for the success of clinical trials. However, it is difficult to find reliable CROs since pharmaceuticals seek partners who deliver comprehensive data and reliable outcomes. We featured a few trustworthy CROs making a difference in the health space in our latest edition of Insights Care - 10 Most Reliable CROs to Watch in 2021. Read their journey that we penned down for you and learn about the developments in the health sphere.
Recent studies reveal that the market value of global CROs is expected to exceed $51billion by 2024. Have a great read! The CROs are responsible for data research, project management, tests and trials, and drug development. They also provide support to medical device industries through their research.
Sumita Sarkar
Editor’s Note
Articles
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THE RIGHT INSIGHT The Importance of CRO in the Biotechnology Industry
#FUTURETECH Tracing the Evolution of Medical Technology
1MED Transforming the CRO Services with Diligence
BIORASI Enabling Pro cient Clinical Trials for Healthcare Service Providers
PIVOTAL An Inventive Approach of Designing and Performing Clinical Trials
SOFPROMED Regulating Essential Clinical Trials and Observational Studies
Cover Story
Clinical Research Excellence Built on the Foundations of Quality
CONTENTS
08
Editor-in-Chief Senior Editor
Sumita Sarkar Anish Miller
Managing Editor
Abhishaj Sajeev
Assisting Editors
Trishika, Vinayak
Visualiser Art & Design Head Co-designer Art & Picture Editor Business Development Manager Marketing Manager
David King Priyanka Rajage Paul Belin Rohil Shinganapurkar Amy Jones John Smith Sarah Wilson, John Smith, Alex Vincent
Business Development Executives Sales Executives
Kelli, Bill, Anna
Technical Head Assistant Technical Head Technical Consultants
Jacob Smile Pratiksha Patil David, Robert
Digital Marketing Manager Assistant Digital Marketing Manager SME-SMO Executives
Alina Sege Amol Wadekar Atul, Gemson
Research Analyst Circulation Manager
Eric Smith Tanaji
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Company Name
Featuring
Description
1Med 1med.ch
Enrico Perfler CEO
1Med is an international company of skilled professionals from the medical device and pharmaceutical industry, from clinical research and the regulatory field.
A10 Clinical Solutions a10clinical.com
Favor Winner CEO and President
A10 Clinical Solutions is a clinical research and clinical care company that works with pharmaceutical companies.
Biorasi biorasi.com
Chris O’Brien CEO
Biorasi is a global, award-winning and full-service contract research organization (CRO) that delivers the speed and agility that today’s small and midsized pharmaceutical and device companies desperately need.
Clinical Trial Service clinicaltrialservice.com
Mirjam Bruggink Founder and Managing Director
Clinical Trial Service B.V. contributes to the optimization process of qualitatively high and reliable clinical research by transferring knowledge and experience obtained by setting up, monitoring and managing clinical research on medicinal products, medical devices and food supplements.
Clinmark clinmark.eu
Marek Wasiluk CEO
Clinmark is a leading Polish Contract Research and Consulting Organization on the Polish market and CEE.
Link Medical Research linkmedical.eu
Ola Gudmundsen CEO
LINK Medical is a full-service Nordic CRO providing product development services for the pharmaceutical and medical device industries across Northern Europe.
Pivotal pivotalcr.com
Dr. Ibrahim Farr Chairman and CEO
Pivotal is a Contract Research Organization that weaves together the scientific insight, the technology and the resources to help customers address both current and future needs.
Sofpromed sofpromed.com
Patricio Ledesma General Manager
Sofpromed is a full service contract research organization (CRO) specialized in the management of phase I-IV clinical trials in oncology as well as in cardiovascular, metabolic, central nervous system, dermatological, infectious, and respiratory diseases.
Syneos Health syneoshealth.com
Alistair Macdonald CEO
Syneos Health® (Nasdaq:SYNH) is the only biopharmaceutical solutions organization purpose-built to accelerate customer success.
Vizera vizera.eu
Mojca Fir Director
Vizera is an European clinical research organization (CRO) based in Slovenia (EU) that specialises in clinical trials for medical devices and nutraceuticals.
Clinical Research Excellence Built on the Foundations of Quality
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Clinmark is a boutique CRO, providing complete solutions for clinical development programs, from the scientific concept, design, execution till marketing authorisation.
Marek Wasiluk CEO
10 Most Reliable CRO's to Watch in 2021
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or pharmaceutical companies to thrive in a competitive marketplace, it is crucial to have a strong understanding of the customers’ demands. Recently, there has been an increased emphasis on Contract Research Organizations (CRO) as they are seen as vital partners in achieving significant results for pharma companies. The CRO industry is growing at a rapid pace with the recent rise of global health concerns such as the ongoing COVID-19, Ebola, Zika, and other diseases. CROs are at the forefront of drug and medical device development. They provide a cost-effective way for pharmaceutical companies to outsource research and clinical trials, while also mitigating risks by selecting from a variety of CRO options. As the global healthcare market continues to grow, the industry is seeing an increasing number of CROs offering innovative services and solutions that are driving new treatments forward in the field. One prominent name among such organizations is Clinmark. In the following interview, Marek Wasiluk, the CEO of Clinmark shares valuable insights into the company’s operations and offerings, the challenges it encountered during the COVID-19 pandemic, his vision for scaling the company in the years to come, and much more. Following are the highlights of the interview: Please brief our audience about Clinmark, its mission, and the key aspects of its stronghold within the contract research niche. This year Clinmark is celebrating its 20th anniversary of establishment. Over this time, we went on a very exciting and successful road – from being a micro business to a modern, flexible, and strong organization, supporting our clients with the whole range of R&D services. Clinmark is a boutique CRO, providing complete solutions for clinical development programs, from the scientific concept, design, execution to market authorisation. What is unique for us is the fact that we have managed to develop and implement proprietary methodology and tools, to easily organise and conduct research projects in any country of the world. So, we can set-up and execute research project almost like a global CRO, being more cost effective, flexible, client oriented and friendly. We operate mainly in Europe and Asia, but we have an evidently sound experience in US and Africa.
Our goal is always to perform a study in the regions which best fit that particular project. It means that we are not attached to subjective criteria while setting up a study, but look at it from every perspective (operational, epidemiological, regulatory, quality, costs and of course Sponsor suggestions and expectations). Such an approach allows us to incredibly quickly set-up and initiate the project. As an example, we provide first subject in the study within 45 days from the project awarded (this is our fastest achievement)! The model we use very well fits any research project, but our clients especially appreciate it when we use it to rescue the project we are requested to take over. It took 5 years to develop our business model, to validate and improve. It is a totally new concept and valuable in the CRO world, and I’m pretty sure that within few years, it will successfully spread out together with our growth. Tell us more about the offerings which make your company stand out from the competition? Our business model is based on five principles: 1. To hear our client. It is key to communicate, and to understand the expectation and needs from one side, and to provide the client with the objective, full picture of projects. We are very transparent in our work, and prefer model, in which client knows everything about the project. 2. Operational excellence meaning that we are experts and do our work professionally 3. Simplicity. The clinical studies are complex by nature and regulations. We make them as simple as possible by avoiding bureaucracy, bottlenecks, unnecessary operations. 4. Quality. This is our blood – an integral part of Clinmark. I’m personally an ISO 9001 auditor by training and experience. So, quality has been and always will be a part of our company culture. 5. Flexibility plus the ease to cooperate. We are known for being very easy to work with. This is our philosophy and is evident in our business model. In addition, because we have a wise business structure, we are a very flexible and scalable company. What is your opinion on the impact of the current pandemic on the global pharmaceutical sector, and what
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Clinmark is lucky to have the right people with passion and interesting personalities.
challenges did you face during the initial phase of the pandemic? The pandemic affected all the world and all businesses. For some it was lethal, for some it was less impactful, and miniscule for a few sectors. The pharmaceutical industry is quite resistant to crisis, as it is about people’s health, diseases, and problems. But R&D is slightly different, as it is sensitive for a delay. The ongoing projects must go on, as it is for patient safety. Clinmark fortunately is a modern and flexible organisation, with expert top management staff. So, the pandemic time has passed quite smoothly. I can even say that it has enabled us to implement solutions which we had been thinking before for some time. So overall, I see the pandemic as an opportunity, and we have exited it stronger. With continuous development in technologies such as AI and big data, what is your prediction about the future of the pharma sector pertaining to contract research and consulting? New technologies, like big data, AI are a revolution for the world. I think that this is a breakthrough almost the same as first flight of the Wright Brothers in 1908. The aircrafts have changed the lifestyle, business models, and human lives. The same happens now with digitalisation of the world. We should be happy and excited to be a part of it. I’m personally a very tech savvy person, fascinated by the technology world, so I’m crossing fingers for its growth. As an established leader, what would be your advice to the budding entrepreneurs and enthusiasts aspiring to venture into the contract research niche? Enter it. It is a fascinating, prospective, and a stable business. But not the easiest, especially at the beginning. Like everywhere, there are challenges sometimes. But if you know the directions and have the right people around, for sure you will be successful. How do you envision scaling your company’s operations and offerings in 2022? Last year, Clinmark was awarded Most Inspiring Company of 2020. In 2019 our project management capabilities were acknowledged; we were nominated by Pharma Tech Outlook as a top 10 Clinical Trial Management CROs in Europe. We are continuously growing, year by year. This year, as the pandemic has stabilised, Clinmark plans to widely
develop its business model, and expand its operational capabilities. If everything goes well in one year, we will be in a different place than today, with double of the current revenue. Meet the Team A company, and in particular the Contract Research Organisation, cannot exist without its people. They are like the blood of the organisation, which carries oxygen and vitamins, but may also carry toxins. The right people can inspire you and direct to success and will carry you through crisis. Clinmark is lucky to have the right people with passion and interesting personalities. Here’s what the leadership team has to say about their journey in the industry through their role at Clinmark: Marek Wasiluk, Chief Executive Officer: It is always difficult to talk about myself. My whole life is driven by passion and curiosity. I have been doing many things in my professional carrier, I’m DMD by education, graduated MBA, accomplished 3 other post-graduate studies, and a trained ISO 9001 lead auditor. I’ve been in the clinical research industry since 1999. I love what I’m doing, and Clinmark is not only my baby, but also my love. Grzegorz Pogorzelski, Chief Strategy Officer: I started my carrier as a Medical Doctor working as a physician at one of the regional hospitals. Upon discovering clinical research studies, I decided to change my professional path and be a part of this world. A lot of challenges, different duties and inspirations filled up my professional life. I assumed this was my destiny. However, when I met Marek and joined Clinmark 6 years ago, unexpectedly new doors have opened. Till this day, it is still a fantastic ride with possibility to create unique masterpieces and generate synergy. Jacek Banach, Head of Business Development: I met Marek during one of the consulting meetings I gave at that time. It was over 7 years ago. Thanks to Marek, the global approach and trust that he gave me, I successfully expanded my passion to connect with professionals from all around the word, delivering unique solutions to the sponsors as the Head of Business Development. Working in clinical trials in international ecosystem gives me fulfilment and the feeling that working together we can improve health around the world. With an opportunity to have fantastic people around, we are building something exciting, having not only satisfaction but also fun.
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We are known for being very easy to work with. This is our philosophy and is evident in our business model.
Transforming the CRO Services with Diligence
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ot more than a decade ago, Contract Research Organisations were known only for conducting clinical trials and lab services. It has now evolved to cater to broader service areas like data analytics, drug development, and the like. Increasing investment by pharmaceutical companies for research and development, the rising number of clinical trials and increase in rare diseases have led to the growth of CRO. Globalization and technological advances in the medical field have added to the impetus. CROs are known for efficient deliverance in clinical trial management services for pharmaceutical, biotech and medical device companies. The Covid-19 pandemic has seen more pharmaceutical companies associate with CROs for R&D and this market is only expected to grow. As per recent research, the CRO market is projected to grow at a compound annual growth rate of more than 10 % by 2026. One CRO that has been making waves in the market for its clinical and
regulatory development is the Switzerland-based 1MED. It provides all the services that are required for the research and development of medical devices. It also offers post-market assistance.
(first-in-human studies, pivotal studies, etc.) to post-market activities to monitor device safety and performance when used in real-world (market surveillance and vigilance, post-market clinical follow-up, etc.).
Enrico Perfler, CEO of 1MED, shared his cognizance of the biotechnology and medical sector in the following interview.
1MED mission, especially towards SMEs, is training them to ensure a clear understanding of regulatory requirements and their implications, assisting them, and partnering with them to develop sustainable products against the industry’s constraints, mainly identified as the time to market and funds required for thorough development.
Please brief our audience about 1MED, its mission, and the key aspects of its stronghold within the contract research niche. 1MED is a CRO focused on assisting medical device companies in facing the complexity associated with the development of medical devices in compliance with MDR by providing support from a strategic, regulatory, quality, and clinical point of view, with a cross-functional approach. 1MED services can encompass all phases of the medical device development lifecycle, starting from pre-clinical phases (device concept, device design, and prototyping, bench testing, etc.), through clinical phases
1MED thrives on working with companies that value innovation and want to make an impact and a difference in setting patient’s clinical needs at the centre of their innovation. In 2020, we were listed among the TOP 10 consulting service companies in Europe by PharmaTech Outlook. But the most important recognition for us is the trust we have been capable of building with our clients and with the hospitals and private institutions we collaborate to develop innovative products.
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1Med in 10 Most Reliable CRO's to Watch in 2021
About the leader Founder and CEO of 1MED, Enrico Perfler, has over 15 years of consolidated expertise in the MedTech industry. His recognized competence in regulatory affairs is proven by his active participation in regulatory working groups at national and international levels. Enrico Perfler is a serial entrepreneur who has founded, managed, and invested in several MedTech start-up companies. He is also an author of internationally granted patents for cardiovascular medical devices and in-vitro tissue engineered models.
Enrico Perer CEO
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Tell us more about the offerings which make 1MED stand out from the competition? 1MED was born to create a Contract Research Organization able to talk on a technical level with medical device manufacturers and to fully understand the technologies that lie behind the product itself. Working with international and start-up companies on new product developments and interacting with EU Competent Authorities and Notified Bodies allowed us to understand that, often, hurtles during the approval processes for innovative medical devices are mainly due to the lack of understanding of the technology and of the benefit that such technology, in the end, may have for patients. Our approach allowed us to support the certification of more than 300 different medical devices with a success rate of 100% in the last seven years. What is your opinion on the impact of the current pandemic on the global CRO vertical, and what challenges did 1MED face during the initial phase of the pandemic? COVID-19 pandemic changed multiple aspects of our life; one of these was limited access to healthcare institutions for non-COVID-19 patients. This caused a drop in emergency department visits, hospitalizations, and delay in surgeries for a considerable number of patients. As a consequence, there was a halt in patient enrolment in most of the clinical trials that were non-COVID-19 related. Also, ordinary activities with clinical sites (e.g., qualification visits or monitoring visits) were significantly reduced.
1MED is inves ng in digitaliza on and ar ficial intelligence by developing IT Tools to capture clinical data and simplify its managment.
With continuous development in technologies such as AI and big data, what is your prediction about the future of the CRO vertical? Recent European Regulations require medical device manufacturers to generate clinical data not only in the pre-market phase for obtaining market clearance (i.e., CE-mark) but also in the post-market phase to confirm their product's risk/benefit profile for certification maintenance. In this regard, real-world data is a key and digital solution based on machine learning, big data are helpful for analysing a huge quantity of data. 1MED is investing in digitalization and artificial intelligence by developing IT tools to capture clinical data and simplify its management. As an established leader, what would be your advice to the budding entrepreneurs and enthusiasts aspiring to venture into the contract research niche?
Both as market trends and regulationwise, patient’s benefit is becoming the core of the innovation: research and development of new medical devices should only have a positive impact on patient’s benefit concerning the standard of care, setting profits, not as the main push for innovation. All stakeholders of the MedTech industry have to become more aware of the ongoing paradigm shift that puts the patient at the centre. The most important message that I would like to convey is that the research and development of new medical technologies in the future should be socially and economically sustainable. Only effective products will be allowed to enter the market, adding value to the supply chain. If products are effective, this also reflects on the national healthcare system, which will be able to guarantee better, faster, and more cost-effective cures with a lower overall impact on the costs of the given treatments, also reducing overall hospitalization rates. How do you envision scaling 1MED’s operations and offerings in 2022? To be competitive and to fulfil patient’s needs, in this dynamic industry, we always need to be up to date and very well trained about ongoing main issues and topics that come up daily. 1MED is reinforcing its MDR and IVDR team to satisfy the increased demand for clinical studies and regulatory services. At the same time, the development of proprietary IT tools for clinical study management and real-world data analysis is key for supporting our growth as well as the acquisition of strategic target companies to accelerate our market penetration in Europe.
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fter the outbreak of the pandemic, companies rushed to find a medicine that could cure the infected people. Along with being a time taking process, it was also highly costly. This affected the pharmaceutical industries and biotechnology industries at the max. Pharmaceutical companies are often at bay regarding the size of the industries, but the biotechnology space is relatively small and just could not handle everything.
chances of the success of the drug. Since you, as the biotechnology industry alone, cannot oversee everything, outsourcing CRO in the development is the way to go. Moreover, despite being a conjugal force, the biotech industry and CRO have recently become the standard. Here is how CRO help the biotech industry: Filling the gap of resources
This is where CRO or Contract Research Organizations came into the picture—helping these industries in the R&D process. Let us assume a hypothetical situation where a similar outbreak of COVID-19 occurs; being in the biotechnology industry, it becomes your responsibility to find the drug for the cure.
Biotech companies lack resources; the inclusion of these companies with CRO fills this gap, helping the companies in research and development. Earlier biotech companies hardly made it to Phase I of the clinical trials, but due to the lack of resources, they could not proceed with the later stages. This forced the companies to merge or take support of large pharmaceutical companies.
Looking at the statistics, it takes approximately $2.6 billion to develop a new drug, which is indeed a huge amount of money for a biotech company to invest. Apart from that, only 12% of the new drugs are approved by the U.S. Food and Drug Administration (FDA), which narrows down the
To maintain ownership and fill the gap of resources, CRO makes the process easy and efficient for biotech companies. Along with that, CRO usually has a wide network, which helps the company with the research, which is often effective and to the point.
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Expenditure Reduction For small and even large biotechnology companies, not every investment is a promising investment. One such similar case is with the investment in the infrastructure of Research and Development. This makes the entire process costly because, along with the manufacturing, the company also has to fund the research and manage the cash flow efficiently. However, outsourcing CRO comes with numerous advantages like increasing the efficiency of drug testing, boosting the success rate and accelerating the drug discovery process. Cost Cutting Biotechnology is a costly industry. Though the profits will recover the expenditure, investing in such a complicated process can often result in losses. CRO brings flexibility and versatility to the company. Helping the company in different sectors like research, development, and delivery to the market makes the complete process much cheaper. Usually, boosting the process of clinical trials makes the trials much economical. The boost in the success rate also adds to the cost-cutting.
The risk of failure is always going to be there for biotechnology industries, despite working side by side with CRO. Also, the inclusion of a better outsourcing option from the market doesn’t need to guarantee success. A biotechnology company must consider all the required factors before hiring any CRO. Along with such factors, time and resource management while working alongside CRO must be considered. The other alternative for biotech companies has been to hire and train people for the job. CRO and the biotechnology industry are highly dependent on one another for the efficiency that they provide. Along with the increased profits, the venture of both the industries marks a differentiating point in the market covering, which makes the product successful, proving the effectiveness of the biotech industry. - Ashlesh Khadse
Completing the Cycle The biotech industry is heavily relying on CRO in the current market scenario. CROs today are providing all the necessary things required in the biotech industry. Starting right from the market research to the final drug approval, CROs are making a huge difference in the success rate of biotech companies. CRO has reduced the time to market for the drug. Despite being an outsourcing industry, it has all the required infrastructure and skills required for the biotech companies to provide critical and high-priority service effectively and efficiently. Having all the resources and a wide network spread worldwide, it becomes easy for the companies to bring out the drug early in the market. The services provided by these CROs vary from project and data management, Quality analysis, Research, Execution, Medicine and Disease Coding, Safety Reporting, Medical Writing, Regulatory Support, etc. With the inclusion of all these services, CRO completes the cycle with efficiency for the biotech industry.
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Enabling Proficient Clinical Trials for Healthcare Service Providers
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linical trials have a huge significance in the healthcare sector as it enables researchers and pharmaceutical companies to develop drugs and medicines that bring revolutionary changes enhancing and empowering healthcare to improve quality of life. While pharmaceutical companies have always relied on companies carrying out clinical trials, few have made a mark by delivering high-quality results, and Biorasi is one of them. Led by Chris O’Brien, CEO with his passion for technology and diligence in delivering consistency, Biorasi has proved itself apart from the competitors through the company’s focus on quality and responsiveness. In the following interview, Chris shares more about the company’s operations and approach towards its sponsors, the effect of the ongoing pandemic on the business as well as his plans for the company moving forward in the postpandemic era.
Chris O’Brien | CEO
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We believe execution is everything in clinical trials, and we focus on delivering high-quality results faster.
Please brief our audience about Biorasi, its mission, and the key aspects of its stronghold within the contract research niche. At Biorasi, we work with sponsors to deliver effective clinical trials for rare
“
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10 Most Reliable CRO's to Watch in 2021 diseases, oncology, and other urgent conditions. We believe execution is everything in clinical trials, and we focus on delivering high-quality results faster. Our speed and responsiveness differentiate us from larger CROs, and our focus on quality (including our recent achievement of ISO 9001-2015 certification) differentiates us from the competitors. Tell us more about the offerings which make your company stand out from the competition? Sponsors tell us they value our transparency and our commitment to partnership. We achieve the first through technology, we synthesize Biorasi data as well as data from third parties to give sponsors real-time insight into the study. Sponsors feel the commitment of the Biorasi team because that team is not spread across a dozen studies. Our dedicated teams make the sponsor a top priority. Chris, please brief us about your journey in the industry. I’m the CEO of Biorasi. I’m passionate about applying technology and process consistency to service businesses. The biggest players in the CRO industry have grown through acquisition, resulting in some very complicated and inefficient companies that mash together conflicting systems, processes, and cultures. We believe sponsors deserve better. What is your opinion on the impact of the current pandemic on the global CRO vertical, and what challenges did your company face during the initial phase of the pandemic? The industry is experiencing 10 years of change compressed into one year. During the pandemic, we first pivoted
Awards and Accolades Named as ‘Entrepreneurial Company of 2020’ in the Clinical Research segment by Frost and Sullivan. Entered the list of Inc 5000 last year for fastestgrowing companies. ISO 9001-2015 certification, an achievement that is very rare in the CRO world and which speaks to the commitment to quality.
to remote operations and remote management of our sites. Then we build out our decentralized trial model. The key here is not anyone’s technology but the synthesis of that technology into efficient processes and the memorialization of this in welldesigned SOPs. The real value lies at the intersection of process and technology. With continuous development in technologies such as AI and big data, what is your prediction about the future of the CRO vertical? Advanced analytics are already playing a role in data hygiene and in-patient identification in clinical trials. We see that role expanding, but you have to be a skeptical consumer. Because AI is both a hot term and an ill-defined one, we’re seeing plenty of companies slap an AI descriptor onto their systems.
entrepreneurs and enthusiasts aspiring to venture into the contract research niche? Understand good clinical practice and the regulatory requirements that are essential for clinical research. We see plenty of health-tech companies that focus more on tech and less on health. You want to build data privacy, 21 CFR Part 11 compliance, etc. from the beginning. How do you envision scaling your company’s operations and offerings in 2022? The biggest challenge today is attracting and retaining great people. The way to do that is to make Biorasi a great place to work. We’re very focused on that.
As an established leader, what would be your advice to the budding
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An Inventive Approach of Designing and Performing Clinical Trials
For pharmaceutical and biotechnology companies, CROs have become exceptionally valuable partners, specifically for the progress of new drugs. As there are several CRO’s vying in the market, the most prevalent issues arise: What are the most trending updates within the contract research niche for Pharmaceutical and Biotechnology to be aware of? Which will be the most suited option to select among so many? And according to their priorities, what are the cursors to be looked at? In this edition by Insights Success, “10 Most Reliable CRO’s to Watch in 2021” we will acme the excellence of these CRO’s that make them the top ten most reliable CROs for you to be affiliated with. In our aspired search of the foremost CRO’s, we came across Pivotal S.L.U. It is a contract research organization that offers a variety of contracting models, from a single source to full service in the chain of drug development activities, from start-up to completion of the corresponding final study report. Pivotal’s scientific team provides risk-management strategies for their client's products to make it the most brilliant choice in the market. In the following interview, Dr. Ibrahim Farr, Chairman and CEO of Pivotal S. L.U. uncovers about the company’s journey about how it has developed into one of the premier CROs and his opinions about the market that their company serves.
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ontract research organizations are emerging as important partners for pharmaceutical and biotechnology companies to conduct clinical research. But with several CROs mushrooming in the market, the pharmaceutical and biotechnology companies are at times confused as to which suits them the best.
All in all, we are learning fast and have the wish and commitment to walk with the times and offer our clients modern accurate solutions for their projects.
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Please brief our audience about your company, its mission, and the key aspects of its stronghold within the contract research niche. Pivotal was founded back in November 2001 by Dr. Ibrahim Farr– with the ambition to become a full-service and therapeutically focused CRO. It has been permanently operating for almost 20 years, on the principle that strategic medical advice and support should be the backbone of all clinical trials. It was recognized since then as an EU-CRO with a solid internal medical franchise, that could act as co-thinkers for our clients and not merely as ‘doers’. It has been providing tactical as well strategic advice in the Clinical Trials landscape. Today, it is headquartered in Madrid and is legally incorporated. It has provided services in >22 countries
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10 Most Reliable CRO's to Watch in 2021
across Europe. We count on Pivotal’s staff proper in most of these countries. Our goal was then and still is to provide our clients with high-quality services across the value chain of drug development activities, from start-up to completion of the corresponding final study report. Although Pivotal is an EU-focused CRO we do have solid established and well tried and tested partners in the US, Asia Pac and SA. We are a full-service organization covering all tasks needed in drug development, with a strong medical and scientific focus and across all therapeutic areas. Major services provided within our services portfolio are: Regulatory affairs and study start-up, clinical trial monitoring and sites/projects management, data management and biostatistics, medical monitoring, PVG services, quality assurance and auditing, biotech consultancy, and patient journey services. We have been awarded to face and succeed in all projects. Pivotal counts with an energetic, long-experienced, clientoriented and committed personnel, always seamlessly pushing forward to drive our clients’ trials and studies to the right place. Pivotal is proud to offer all its clients highly customized teams that bring a combination of broad industry knowledge and operational excellence that allow us, in turn, to offer our clients fresh perspectives and breakthrough business insights. Lastly, we want to stress that we are committed to new technologies and challenges and are on the way to promptly make a shift to – or at least also offer - the possibility of designing, conducting, and managing that new kind of virtual clinical trials with all their new specific requirements and demands. We will not lag. Tell us more about the offerings which make your company stand out from the competition? Below are, in short, major reasons why we think Pivotal may be a preferred option for several companies, which are looking for a CRO to partner with when planning to set up and conduct a clinical study:
About Dr. Ibrahim Farr Dr. Farr is MD by training and specialist in psychiatry and pharmaceutical medicine. And has brought Pivotal thirty years of experience in drug development. He has worked in companies like – Marion Merrell Dow, Cyanamid/Wyeth, and Rhone-Poulenc Rorer/Aventis. Dr. Farr has devoted his life to clinical research and drug development from both the Pharma and the CRO side. It is the result of spending years in managing clinical research for the Pharma sector, and thanks to his scientically driven mind that he realized how important it was to count on solid strategic medical advice and support as the backbone of all clinical trials. Then he jumped out of Pharma and transited to the CRO side as he founded his own company ‘Pivotal’, with a purpose in mind, to not merely activate and conduct trials, but also ‘think the trials’ for and with the clients themselves while walking with them hand in hand all the way down.
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• Client-oriented approach: Our senior management is approachable and directly involved in the clinical studies. Our operational team is energetic, client-oriented, and deeply knowledgeable • • • •
Full-service solution Therapeutic focus across many areas Cost-effective solution Scientific expertise with the internal medical division staffed our medics, specialists in several areas like oncology, hematology, clinical immunology, cardiology, internal medicine, CNS, and more. And will be the backbone of the trial by bringing in-depth therapeutic expertise and strategic advice • Geographical reach across Europe with solid partners in the US, Asia Pac and SA • One-team attitude, integrity, and commitment What is your opinion on the impact of the current pandemic on the global CRO vertical, and what challenges did your company face during the initial phase of the pandemic? Challenges have been felt and encountered by all CROs while providing clinical research and services to those
Pharmas and Biotechs like Pivotal did throughout the pandemic. Nevertheless, we consider the pandemic a good opportunity to streamline processes as well as bring to life a new methodology for drug development. New technologies on one hand, and the COVID-19 pandemic on the other, are demanding us to re-think the old in-house procedures. For example, no paper anymore and imposing the learning of how to manage trials involving the use of those new technologies, and which walk close together with the handling of clinical trials from a new ‘virtual’ or ‘decentralized’ perspective. And these are likely the most defiant challenges long trackrecord CROs like Pivotal will have to deal with rapidly. At Pivotal, we understand all these demands and are committed to new thinking paradigms and technologies. The COVID-19 pandemic has forced Pivotal to adopt new working ‘remote’ scenarios, and although many of our studies have been impacted by COVID-19 and none have been particularly delayed or cancelled because of this. With continuous development in technologies such as AI
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and big data, what is your prediction about the future of the CRO vertical? Today, we have done enough research on the same and have worked towards removing paper from most of our procedures. We have even developed a proper internal bred cloud-based trial tracking system called ‘Danah’, which includes solutions to create robust and reliable tracking systems and eTMFs. All in all, we are learning fast and have the wish and commitment to walk with the times and offer our clients modern accurate solutions for their projects. We are ready to rapidly assist our clients to shift to this new environment by leveraging all newly available tools.
At Pivotal, we are quite conscious of how lack of adequate enrollment may impact the trials of our clients and hence Pivotal has recently acquired and rebranded as Pivotal Patient Journey, an independent EU-based company focused on accelerating patients and healthy volunteers' recruitment within Europe and the US. Therefore, with the aim to improve patient outcomes always in mind, we have developed and embraced patientcentric thinking. And our patient-centered services leverage the patient´s perspective to enhance awareness, recruitment, and retention. C-Lys is our cloud-based patient management platform, fully customizable to your studies, which may provide a range of automation and survey solutions to efficiently manage patient recruitment.
As an established leader, what would be your advice to the budding entrepreneurs and enthusiasts aspiring to venture into the contract research niche? The first piece of advice is that an entrepreneur venturing into this industry should be scientifically and quality minded. Secondly, he/she should focus on delivering highquality work to help bring new medications to the clinic, to address the unmet medical needs of many patients and support the advancement of Medicine. Leadership by example is a must in our industry, hence, the third piece of advice is that the leader´s involvement in the day-to-day work is essential to evolve the firm and produce the desired growth and that he/she should be the face of the company for the client. How do you envision scaling your company’s operations and offerings in 2022? Much of the story discussed in previous sections has to do with the expected coming of a new way of planning and conducting clinical trials. Certainly, CROs will have to adopt these new requirements and learn how to play in the new virtual scenario but ancient typical problems of clinical trials will still be there. And we believe that one of the most important hurdles in all R&D work has always been and will be patient recruitment. Strategies to optimize enrollment shall always be considered as these may enormously help to warrant that target figures to provide robust and sound scientific conclusions are met and to help control the budget of the project when enrollment issues are noticed too late. This will help in the prevention of incurring additional costs.
Pivotal has adhered to the Alliance for Children´s Vaccination as well as other NGOs in the area. Pivotal collaborate along with Gavi, an international organization and Global Vaccine Alliance, in the ght against children’s mortality in the world’s poorest countries. Pivotal has been selected as one of the few rms that attracted recognition from the Pharma IQ network as a ‘RISING STAR’. This survey was performed independently by Pharma IQ among their international community members who were asked to nominate CROs for 2018, which they recognized as the leading and the best in the pharmaceutical and biologics industry based on their own experiences. The research base was made up of international participants from mainly big pharma or biotech, SME pharma and consultants, government bodies, medical device manufacturers and public hospitals. The above is just a sample of the awards and recognitions received, which are very much related to our client's continued condence and trust in Pivotal as their valued partner in clinical research and the quality of services Pivotal provides across a broad spectrum of clinical trials and therapeutic areas.
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H
umans have come a long way from relying on an old man for medical treatment to keeping track of their health by simply wearing a watch. Earlier, a man had to depend on big machines to get that essential data to tell their health condition. The processing of this data would take days, which today is just a matter of a few hours. This is all because of the medical technology that is still upgrading and making a difference in our lives. Innovations and advancements in technology lead to the foundation of medical technology. However, the need for medical technology was felt because of the ineffectiveness of humans in treating complex conditions. The global scenario back then also demanded the need for equipment and machines that could assist doctors. Looking back at the history of medical technology, it developed with simple tools like the flexible catheter, which was developed by Benjamin Franklin and his brother in 1751.
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To know what we have today, we need to know what we had in the early days. The evolution of medical technology existed from the time humans started to study anatomy. However, the required boost that medical technology needed came in the 19th century, and since then, there has been no looking back. To uncover the important events, let’s cover the major technological advancements in each century’s healthcare field.
Computed Tomography scanner. It was clear by then that the arrival of computer technology was going to transform the whole healthcare industry, and soon after that, in the year 1978, Dr. Raymond Damadian discovered a technique of Nuclear Magnetic Resonance, which was used to differentiate normal cells and cancer cells. The advanced development in this technique was later used to develop MRI.
19th Century: Invention of the symbol of the medical profession
21st Century: Advance Medical Technology and the Current Scenario
When you hear the word ‘doctor,’ instantly, a picture of a man in a white coat and a stethoscope around his neck appears. Did you know that the medical profession’s signature or symbol was invented in 1851? Rene Laennec invented the stethoscope because he could not hear his patient’s heartbeat by placing his ear on her chest. Though it was made up of wood and looked like a trumpet, it has surely come a long way since then to become a symbol of the medical profession.
The century started with the announcement of a landmark project in the field of medical technology. The research on Human Genome Project was started in the year 2000 and completed in the year 2003. It is because of this project that we acquired in-depth knowledge about human DNA. Soon the medical technology developed so much that a year later, the first prosthetic joint was invented. The artificial knee, elbow, or forearm made up of plastic allowed the users to adapt and freely use their body parts. This allowed the impaired patients to move their joints freely.
Twenty-three years later, in 1874, a British scientist named Richard Caton used a galvanometer to determine electric impulses in the brain of animals. This theory was later used in the development of ECG, which is commonly used in medical practice today. However, a still in practice drug used during surgery to minimize pain, anesthesia, was used prior to these inventions. Dating back somewhere in 1841, Crawford Long used diethyl ether as anesthesia to remove a part of the tumor around the neck region of his patient. All these discoveries and inventions triggered the need for medical advancements. 20th Century: Setting the Benchmark for Medical Technology The trigger set in the earlier century was carried on to the 20th with many inventions and discoveries. However, one of the benchmark inventions of the 20th century came in the year 1903, when Dr. W. Einthoven, a Dutch scientist, developed an electrocardiogram. Though the equipment was huge in the early days, it is still one of the fastest and simplest tests to evaluate the heart.
The advancement in medical technology was boosted as computers became more common and allowed flexibility in research. Soon in the year 2006, two scientists developed stem cells to create a functional liver. Though the liver was not implanted in any humans because of the size, the application and use of stem cells proved to be significant in later years for research. It was in this century that mankind saw a rise in medical technology. In the current COVID-19 pandemic scenario, due to the advancements, the time taken for the development of the vaccine was cut down to one year from four years. Along with that, the healthcare industry transformed itself with the application of Artificial Intelligence and Machine Learning. The introduction of wearable devices allows users to keep track of their health conditions. This is how the medical industry has transformed over the years, providing humans with an effective and reliable healthcare system along with the flexibility in maintaining and tracking our health conditions.
The next benchmark evolution in medical technology came in the year 1971 when Dr. G. Hounsfield developed the first
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-Ashlesh Khadse
10 Most Reliable CRO's to Watch in 2021
Regulating Essential Clinical Trials and Observational Studies he recent pandemic made the whole world realize the significance of clinical research. The CRO industry was one of the sectors that was in focus during the COVID-19 pandemic to conduct vigorous clinical trials for producing an effective vaccine to combat the coronavirus.
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managing phase I-IV clinical trials in oncology for biotechnology and pharmaceutical companies worldwide. The company was founded in 2012 and offers a one-stop approach including regulatory, clinical operations, data management, and statistical programming capabilities to manage cancer trials from beginning to end.
In doing so, CROs had to consider the various processes that went into developing an efficient vaccine, which would help battle the lethal virus.
Tell us more about the offerings which make Sofpromed stand out from the competition?
Sofpromed is one of the leading CROs that specializes in the global management of phase I-IV clinical trials worldwide for biotechnology and pharmaceutical companies. In the following interview, Patricio Ledesma, the General Manager elaborates on how the company is making an effective contribution in the healthcare space, the challenges that the company came across, and his vision for the company’s future. Please brief our audience about Sofpromed, its mission, and the key aspects of its stronghold within the contract research niche. We are a full-service clinical research organization (CRO) specialized in
Our key differentiator is a longstanding expertise in managing oncology clinical trials including less frequent tumors such as sarcomas, and rare gynecological and pediatric malignancies, among others. Through our deep knowledge of the rare tumor space and our already established network of high-volume cancer centers across Europe and the United States, we are able to offer effective clinical site selection and fast patient recruitment for sponsors developing anticancer therapies, in both early phase and late-stage studies. What is your opinion on the impact of the current pandemic on the global CRO vertical, and what challenges did Sofpromed face during the initial phase of the pandemic?
The appearance of the pandemic had a favourable business impact on those CROs that were awarded to manage COVID-19 clinical trials. During the high peaks of the pandemic, the number of coronavirus clinical studies initiated around the world increased massively, substantially augmenting the workload of CROs managing these types of studies. On the other hand, the abrupt rise of COVID-19 studies at clinical sites affected the staff and technical resources dedicated to clinical trials in other therapeutic areas. During the initial phase of the pandemic, Sofpromed, as a CRO specialized in oncology, observed how cancer patient recruitment slowed down across all studies, and how patient management quality was diminished due to lack of internal resources at sites, restricted access, and less hospital visits. With continuous development in technologies such as AI and big data, what is your prediction about the future of the CRO vertical? The application of new technologies, such as AI and big data, to clinical trials are already key value and leadership drivers in the CRO market. Being a technology driven CRO is not an option anymore. Data-based clinical
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About the Leader Patricio Ledesma, Sofpromed’s Founder and General Manager, accumulates more than 15 years of experience in the cancer clinical research sector, with wide expertise in leading clinical operation teams in both academic and commercial clinical trials. Through the years, he has established strategic collaborations with academic cancer research groups and international key opinion leaders, facilitating the effective implementation of multinational clinical studies. He is devoted to helping biotech companies in the planning and execution of phase I-IV clinical trials across North America, Europe, and Asia-Pacific.
trial simulation can be useful to improve inclusion criteria. Leading CROs are already adopting AI tools in their workflows. Data analytics provides tremendously valuable information that can improve site selection, recruitment rates, and eventually patient outcomes. Therefore, CROs will need to step into these tools to take their offerings to the next level. As an established leader, what would be your advice to the budding entrepreneurs and enthusiasts aspiring to venture into the contract research niche?
Being a technology driven CRO is not an option anymore. Data-based clinical trial simulation can be useful to improve inclusion criteria.
Although the CRO industry is led by big multinational players, there is and there will always be abundant market opportunity for small-sized, emerging CROs, which are able to offer value to clinical trial sponsors in general, and to small biotech in particular. As in other businesses, technical capacity and customer care are essential, but especially in the CRO space, operational flexibility and responsiveness towards the client makes a world of difference. My main advice for an entrepreneur aspiring to venture into a CRO business would be ensuring a good service and really care for the needs and problems of your clients.
How do you envision on scaling Sofpromed’s operations and offerings in 2022? After 10 years of its foundation, Sofpromed has experienced quick growth in recent months, as the company is rapidly expanding its biotech customer base dedicated to executing international phase II and III clinical trials across Europe and the U.S. The company has an exciting perspective to continue with its organic growth through an increased presence in the U.S. market and the provision of state-of-the-art clinical data management and statistical programming services.
The clinical trial management sector is an exciting world full of opportunity.
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