Oncology brochure october 2013

ONCOLOGY

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THE PSI STORY

Oncology Clinical Trials

Approved

www.psi-cro.com

Being a full service CRO is challenging in its own right. But being a CRO that takes the unique approach of ‘pitching’ on-time project delivery in today’s changing global environment takes it to the limit. The majority of our global projects have milestone-driven payment schedules and clients do not pay until they see results. This is a tough measure of success, and people who work at PSI know that better than anyone.

We believe that PSI’s approach and performance addresses the biggest challenge in our industry. According to various sources, more than 90% of trials run behind schedule, costing sponsors millions of $$ in delays to market. Contrary to ‘normal’ industry performance, 95% of PSI studies finish on-time or ahead of schedule. This may sound incredible to many; however, such sustainable results are not a miracle.

It’s what happens when dedicated employees focus their proficiency and a client-centric approach on two things; in-depth feasibility and ‘go the extra mile’ project management.

We subscribe to the belief that “it’s kind of fun to do the impossible”. We maintain our practice of investing in talent because we know that only devoted and accountable employees can deliver the kind of service that will ensure outstanding results for our clients.

Our mission is to be the best CRO in the world as measured by our clients and our employees. With 1,400 folks in 50+ countries we have a lot of talent to look after. Dozens of customers in a variety of therapeutic areas have come to PSI and stayed. Maybe that is why after 20 years in the industry PSI still enjoys a solid reputation and grows mainly through repeat and referral business.

MULTIPLE MYELOMA REGULATORY CONSULTANCY FEASIBILITY STUDY LUNG CANCER ACUTE MYELOID LEUKEMIA CREATE CRF SET UP STUDY DATABASE STATS ANALYSIS PLAN SITE SELECTION SET UP STUDY LOGISTICS STUDY FILING WITH COMPETENT AUTHORITIES

AHEAD ON TIME ON TIME AHEAD ON TIME AHEAD AHEAD ON TIME ON TIME ON TIME

SITE CONTRACTS CINV BREAST CANCER SITES ENROLLMENT READY PROSTATE CANCER FIRST PATIENT IN PANCREATIC CANCER RENAL CELL CANCER LAST PATIENT IN LAST PATIENT OUT NON HODGKIN’S LYMPHOMA LOCK DATABASE FINALIZE INTEGRATED REPORT

ON TIME ON TIME AHEAD ON TIME AHEAD ON TIME ON TIME AHEAD AHEAD AHEAD ON TIME AHEAD ON TIME

ON TIME

ICAL

T LOGIS

MEDICAL

FEASIBILITY The upfront investment of time and medical expertise into each feasibility assessment underlies PSI’s patient enrollment success in oncology trials.

For oncology studies, where competition for patients and complexity of design are leading characteristics, we apply our years of experience to determine the best sites and countries for each study.

We give every project a thorough assessment through our dedicated, full-time Feasibility Department. With people located in 11 countries of North America, Europe, Asia and Latin America and led by our team of internal oncologists, medical doctors, laboratory experts, imaging specialists, logisticians, pharmacy and regulatory experts, PSI predicts accurate dates for the enrollment of the first and last patients.

In recent years, our specialists have conducted hundreds of feasibility assessments for oncology studies in 50+ countries.

These assessments cover, but are not restricted to, evaluation of the target population availability and factors that limit it, standards of care, competitive studies, regulatory climates and the need to engage particular Key Opinion Leaders into the study.

We weigh all of these factors before making recommendations.

Our value-added feasibility assessments for regional or global programs provide our sponsors with the best choice of sites & geography, ensuring predictable and accurate enrollment projections.

CAL

I CLIN

ACCOUNTABILITY: DOING THE RIGHT THING PSI’s reputation is that of a no-nonsense CRO that delivers by taking the right actions even when that is the harder path.

However well one plans a study, the unexpected will happen.

What differentiates a good vendor from everyone else is the manner in which difficulties are managed. At PSI, studies enroll on time not only because they are well-planned, but also because the project teams assume an attitude of “get it done or die trying”. Most of the projects we undertake are “tough”. PSI has won many unwinnable battles by sheer persistence in an effort to keep our promises to our clients.

To us, doing the right thing means: • We carefully assess opportunities and only bid on those we believe we can do well.

• We do our best to keep your expectations in line with reality because we are accountable for every promise we make.

• We speak our truth even if it is not what you expect to hear.

We wish to guide you on the right path, not let you believe something just because it is what you want to hear.

• We show you how we can meet your study timelines by telling you which countries can enroll and how to realistically integrate the contributions of strategically important regions and KOLs. • We stand by our operational promises and offer to develop a contract where we are remunerated when we reach delivery milestones.

LOYALTY Over the last 18 years, PSI has grown primarily due to repeat and referral business. Our world is divided into two groups of customers: Those who know and like PSI and those who have not had the chance to work with us. We want you in the first category.

When you get to know us, you will see that our interest is not transactional. It is not one study we are after, not even two. We want your trust. We want you to be so pleased with PSI that you will feel we are the best choice. And we want you to tell others about your good experiences. Our goal is to develop a relationship that grows, lasts and only gets better as the years go by.

Customers are most important to PSI after our employees.

Nothing is as important to us, or you, as staff loyalty. Your team knows that there is work and then there is one’s life work; the kind of work on which you would never compromise; the vocation worth a sacrificed weekend. People do not come to PSI to play it safe. They come here because they want to do something significant; to make a contribution by doing the right thing; something that could not happen anywhere else.

When combined, these characteristics yield tangible outcomes for our customers. Studies run on time and on budget and save hundreds of millions of development dollars.

PSI HAS IN-DEPTH ONCOLOGY EXPERIENCE IN THE FOLLOWING PHASE II-IV STUDIES: Breast Cancer Gynecological Cancer Ovarian Cancer Endometrial Carcinoma Gastroenterology Colorectal Cancer Gastric Cancer Pancreatic Cancer Esophageal Cancer Hepatocellular Carcinoma Urology Bladder Cancer Prostate Cancer Renal Cell Carcinoma Pulmonary Non Small Cell Lung Cancer Small Cell Lung Cancer Melanoma

Solid Tumors † Hematologic Malignancies Lymphomas Leukemias Multiple Myeloma Head & Neck Cancer Supportive Care CINV † Chemo-induced Neutropenia Chemo-induced Neurotoxicity Chemo-induced Diarrhea Pain in Bone Metastases Radiaton-induced Mucositis Oral Mucositis in Head & Neck cancer Rare Cancers † Ewing family of Tumors or Rhabdomyosarcoma †

pediatric indications

ONCOLOGY CASE STUDY 1 Global Pivotal Phase III 500 pediatric patients were recruited at 71 sites in 17 countries across 3 continents. The target of 500+ enrolled patients was met on-time. The study set-up finished within the projected timelines in all regions.

Challenges and Success factors: þ

Sound planning. This study was run across 3 continents in 17 countries, all with their own unique regulatory requirements for the special patient population. All submissions were made on time, including 3 countries in Latin America. This was achieved by having specific start up teams who managed all aspects of study management at this stage.

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Excellent feasibility. We performed an exhaustive feasibility assessment before study commencement due to the special requirements for the study’s patient population in each country and at each site.

Selecting the right countries and sites was critical.

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Expertise. The PSI project team members that were appointed to this study had in-depth expertise in managing global oncology trials. Because PSI’s monitors, project managers and medical experts managed the sites closely and provided the investigators with all relevant information in a timely manner, they developed and nurtured excellent relationships with them. This translated into stellar enrollment.

ONCOLOGY CASE STUDY 2 Global Pivotal Phase III In this very challenging project, PSI enrolled 254 patients at 88 sites in 16 countries one month ahead of schedule.

Overcoming Challenges and Obstacles: þ

Uncertain Investigators. This was a study in which investigators were reluctant to enroll patients into a study where the comparator was Best Supportive Care. Even though patients had already failed 3 lines of chemotherapy, offering the possibility of Best Supportive Care made an indirect statement to the patient that many investigators were unaccustomed to making.

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Patient Pre-Screening. For inclusion, the patient needed documentation of disease progression. Many patients had been treated at different institutions and often their records were difficult to access. PSI utilized our medical monitors, with the Sponsor’s blessing, to work directly with the investigators to assist them in obtaining necessary pre-selection documentation, thereby allaying their concerns and frustrations.

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On-Time Delivery. Sound planning was needed to meet all significant milestones on-time. The sponsor’s corporate goal for LPI was unchangeable. From the get-go, PSI was fully committed to deliver every milestone

as planned. PSI created an in-house team of 12 attorneys and contract specialists to work along with PSI regulatory personnel, acting locally, regionally and centrally with the Sponsor, to minimize the time to site contract signature. This allowed to get the sites contracted and initiated on or ahead of time in most of the countries, which set the right tone of on-time delivery throughout the project. Ăž

Hands-on Project Management. The PSI global team knew their sites well. Daily contact with every site, go-the-extra-mile support and commitment of PSI CRAs in every country made a difference.

Kudos to the PSI teams that produce enrollment graphs like the one below. They are the PSI that makes us proud.

ONCOLOGY CASE STUDY 3 Phase III Oncology Study 300 patients were recruited at 55 sites in five countries in 6.5 months; an average monthly rate of 1.1 patients per site.

(Incidentally, this was one month ahead of schedule.) We offer this as an example of PSI’s usual performance in a challenging enrollment environment, given that the Study was competing, directly or indirectly, with another 250 studies running in the same indication worldwide..

Success factors: þ

Sound feasibility. With 250 similar studies running concurrently, PSI had to look closely at each investigator.

We selected only those sites determined to have sufficient patients and the ability to give full attention to study enrollment.

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Regulatory planning. To achieve the FPI goal set by the Sponsor, PSI carefully evaluated the published regulatory timelines of various countries against our own experience with regulatory review periods to choose the most appropriate countries.

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Expertise. The PSI project team that was selected for this study had in-depth expertise in managing complex trials in this oncology indication.

ONCOLOGY CASE STUDY 4 Pivotal Phase III Trial 725 patients were enrolled at 60 sites across Europe in a mere 14 months. This was 1 month ahead of schedule.

Success factors: þ

Scrupulous feasibility. Every site was handpicked. PSI only recruited investigators we had worked with previously.

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Sound planning. Having, knowing and following a watertight operational plan allowed PSI to start up the majority of the sites on a compact schedule.

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Experience. The PSI project manager brought in-depth expertise in managing complex oncology trials.

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Investigator rapport. Years of joint collaborative efforts have nurtured an excellent collegial relationship between the best enrollers and PSI’s monitors, project management group and our medical staff.

PSI Global Map Oncology Trials Worldwide

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