Outsourcing Clinical Trials How to select the CRO for a clinical trial

A rapid response

With these frailties in mind, rapid action has been needed on the part of SUT suppliers to safeguard their customers.

During the first wave of COVID-19 in particular, many suppliers of SUTs took steps to minimise their exposure to potential points of failure, such as just-in-time (JIT) deliveries. Maintaining adequate levels of essential raw materials, and building stocks of finished components within key overseas markets, have been important ways of addressing this issue. It ensured that manufacturers could continue to manufacture their components and deliver them to customers without disruption.

needed. Multi- or dual-sourcing can also help to enhance the flexibility of supply, helping businesses to respond more rapidly to issues with individual partners.

Partner with reliable suppliers

Finally, it is crucial to seek out and work with partners that are reliable and have the capacity to support manufacturers in achieving their supply chain security goals.

It is advisable to work with consumables suppliers that have, themselves, taken steps to enhance the robustness of their supply chains, whether through diversification, the introduction of multisourcing or the building up of stock. Asking potential partners about their own supply chains, and about their global operating footprint, can help manufacturers understand whether they will be able to complement and boost their own efforts.

Working with suppliers that have a global operating footprint, with sites and operations in multiple countries, can also optimise the robustness of supply chains, as they will be less vulnerable to localised or regional supply challenges.

It is important to work with partners that have a reputation for reliability and quality. They must be able to offer you a consistent service and deliver the high-

Another step taken by SUT manufacturers has been to try to expand their footprint beyond their core markets, establishing new sites within their customers’ geographies. Given that countries such as the US and India have been incentivising their domestic pharmaceutical sectors to localise or “onshore” their supply chains, establishing local sites can help SUT manufacturers address customers’ concerns about relying on imports.

SUT manufacturers have also begun reconsidering their own supply chains to optimise their resilience, and to support customers in achieving the same goal. Diversifying their network

est standard materials and components to help you ensure you can operate consistently.

In addition, it is important to seek out suppliers that you can be confident will continue to operate for the long term. Exploring suppliers’ financial health before making any agreement can help give you the peace of mind that they can be relied on for the long haul.

Time to shield yourself from economic uncertainty

While the economic turmoil from COVID19 looks to be settling down in many parts of the world, there are other developments that have the potential to pose challenges for the global economy, and for the pharmaceutical industry in 2022 and beyond.

It is important for pharmaceutical companies to prepare now to ensure their essential supplies, not just of raw materials, but of SUTs and other key components, are secure and sourced from reliable partners so that they can continue to operate.

Pharma companies don’t need to take responsibility for this preparation entirely on their own shoulders — they should work with suppliers that are doing the same and securing their own networks. Such suppliers create of suppliers beyond individual companies or single regions is an important way of preventing the creation of single points of failure, so they can continue to supply customers.

Dual- or multi-sourcing is also another key measure taken by a growing number of SUT and other consumables manufacturers. Multi-sourcing describes a supply planning system that can intelligently choose between alternate sources of supply. While not without its own complexities and challenges, this approach has the potential to allow SUT manufacturers to respond in real time to disruption, enabling them to switch from an affected supplier to one that is able to continue to deliver.

resilience further down the supply chain, helping to support the wider pharmaceutical industry in creating a more robust, secure and certain future.

More for information, please visit Product Filtering | Powder Transfer Systems | ChargePoint (thechargepoint.com).

AUTHOR BIO

BEN WYLIE is the Senior Product Manager at ChargePoint. He joined ChargePoint in 2005 and is responsible for the day-to-day and strategic management of the product portfolio, including the development of the ChargePoint single-use solutions. Ben has 14 years of experience in Pharma with a focus on marketing and product management of powder processing and containment handling.

OUTSOURCING CLINICAL TRIALS

How to select the CRO for a clinical trial

Clinical Trials are an integral part of drug development and are often outsourced to third parties clinical research organisations (CROs) for execution. The selection of a CRO for a trial is usually based on certain parameters. An experienced CRO can complete the trials smoothly, while a non-experienced CRO may worry the sponsor. All CROs are good but not necessarily all are experienced and capable to handle your specific trial requirements, even your preferred CRO. Any negligence in trial design, planning, or conduct jeopardises the outcome of the trial results. Therefore, the selection of a CRO or an outsourcing partner is critical and challenging. It’s both a science and an art. To master this process, the selector or the team at the sponsor company should define clear objectives and expectations from the clinical trial. These objectives and expectations should be documented, which may be used to evaluate CROs. As such, there is no universal checklist or a gold standard checklist for selecting the CROs, but certainly, there are a few common parameters which can help make the final decision. This article lists the common parameters which can be used as per the requirements of your specific studies, because like every molecule, every study is different. .

Rajendra Talele, Pharmaceutical Professional

Clinical trials are an integral part of drug development that decide the outcome of the newly developed or the newly formulated medicines. A well designed, planned and executed clinical study can bring success to an average drug molecule too, and a poorly designed or executed study can kill a promising molecule. Often, clinical trials are outsourced to CROs, may be end-to-end or a part of the study depending on the sponsor’s need. The sponsoring company outsources trials due to two primary reasons:(a)either the sponsor company does not have the required expertise to design, plan and execute a trial, or (b) does not have enough bandwidth to execute the trial. Many times, the sponsors are clear about the objectives and expectations from the trial, and they ask the selected CRO to design a study around those objectives and expectations. However, when the sponsors are not clear on the objectives or the expectations from their clinical trials, they ask the CRO to study and design the trial accordingly. Therefore, in either case, it is important to select an experienced, and eligible CRO to undertake a clinical trial project. This makes the selection of the CRO and the outsourcing of the clinical trial a critical and crucial affair.

The outsourcing of the clinical trial is challenging, and it is a skill. It is a process and not a one-time half an hour event. However, few sponsors think of outsourcing as an event and without a thorough evaluation of the CRO, make their decision in haste. Often such sponsors regret their selection which was based on selective criteria. The selection of the wrong outsourcing partner not only jeopardises the prospect of the molecule but also attracts a lot of trouble shooting which demands the sponsor’s time. To avoid such regrets and troubleshooting, the sponsor must clearly document the objectives and expectations of the proposed clinical study. This would help in evaluating the CROs and while there are no universal checklists, there are a few parameters and flags to look out for while making the selection. We will discuss these below, but before enlisting