The successful execution of a clinical trial means that the project is finished on time, on budget, and has a high level of quality. Changing regulations, importation requirements, and many other factors have to be taken into account when conducting international trials. Having a detailed plan that covers supplies, storage, and distribution is essential. Working with a global clinical supplies partner can make the difference. But how do you choose the right one?
Five key characteristics
These are the five key characteristics that we believe a global clinical supplies services partner needs to have to be able to deliver outstanding results in an increasingly complex and competitive world.
- Demonstrated experience with multinational studies
Proven experience is essential. Look for a service provider that works on a large percentage of international studies and is used to global trial complexities and successfully managing operational, regulatory, etc. challenges and opportunities. The company should be specialized in clinical trial supplies and biological sample management services to be able to handle the many, very specific challenges and constant changes in the industry.
- Global reach
Your service provider should own facilities for clinical trials in key geographic areas on every continent. They also need to have a qualified global partner network of depots that cover every area of the world to ensure that they can bring medication to patients quickly and efficiently, and handle regulatory requirements.
- Brexit capabilities
Being global also means dealing with regulatory uncertainties such as Brexit. About 25% of QPs (Qualified Persons) in the EU are UK-based. In the future, they will not be allowed to release drug products for the EU anymore, so a shortage of continental EU-based QPs is projected. Also, some manufacturing and logistics firms are building new facilities to serve the post-Brexit EU, but it will take them time to get up to the necessary standards.
- Due to the complexity of the European supply chain, it is recommended to start working with a firm that is already operating on the continent to avoid shortages or delays in getting medication to patients in the UK and continental EU. Having an established facility within the UK will also be important, whatever the final decisions on Brexit will be.
- Project flexibility
Choosing a firm with agile managerial and operational systems that are built to accommodate ever-changing clinical protocol requirements and fast turnaround times without sacrificing quality is key. They can customize services to specific client or study needs.
- Creativity and innovation
With all the challenges involved in planning and organizing around constant changes, a service provider should be able to think outside the box. Suggesting alternative methods to proceed and considering innovative services versus traditional ways of working can make a trial more cost- and time efficient. A good international service provider must leverage their global expertise to identify and execute creative clinical supply solutions for all clients.
Expanded global footprint
Now that CSM is a Clinigen Group company with facilities in the US, UK, EU, Asia and Africa, both you and patients can benefit from our expanded global footprint and our specialist global infrastructure. We are unique in our ability to serve all of your pre-launch needs from Clinical Trials to Investigator Initiated Studies to Managed Access Programs. CSM has over 20 years’ experience providing reliable and innovative services that deliver outstanding results. Over 50 percent of our trials are multinational. We ship to 85+ countries and have a depot network over the five continents.
CSM is also well positioned to serve your post-Brexit needs. We have EU GMP facilities in Brussels and Frankfurt that are staffed with certified QPs who have decades of experience and outstanding quality and regulatory track records. Thanks to Clinigen, we now also have established facilities within the UK.
CSM is a global service provider that is big enough to deliver best-in-class services, but agile enough to customize the service offerings for each trial. With innovative services such as On-Demand and Direct-to-Patient, both pioneered by CSM, we are perfectly positioned to support the success of your global study.
How can we help your international trial? Speak to a CSM expert to discover our tailor-made solutions.