Le lien logistique dans les essais de thérapie cellulaire et génique réussis
Coordination des personnes, processus et technologies
The success of a clinical study depends on the CRO’s or sponsor’s ability to bring together people, processes, and technology in a coordinated effort to improve patient outcomes, one case at a time.
Logistics partners play a similar central role in the process by transporting medications and bio-materials between laboratories, manufacturers and clinical sites around the world. Their success is critical to the success of the study as a whole, and never more important than in studies of personalized medicines, such as cell and gene therapies.
To coordinate people, processes, and technology effectively, your logistics partner will need to develop and execute:
- Detailed transport planning that clearly identifies key variables (routes, airlines, flights, hours of operation, lockouts, recovery, Customs, regulatory requirements and past performance) to optimize patient scheduling and minimize risk.
- Study-specific SOPs that carefully outline every process and procedure, and delineate lines of responsibility.
- Dedicated training and 24-hour support at every study location for all stakeholders coming in contact with the operational process (clinical operations, investigator site personnel, external suppliers, logistics provider’s customer service and operations personnel, agents and brokers).
- Engagement of external partners, including outreach and orientation to airlines, cargo operations, ground handlers, customs agents, security and public safety officials in every study location.
- Advance contingency planning capable of resolving a variety of unexpected situations.
- Exceptional communications between all stakeholders and members of the operational team to identify problems, initiate corrective actions and resolve issues as they occur.
To learn more about what to look for in a logistics partner for your cell and gene therapy clinical trials, please download our e-book - Tomorrow’s Medicine: Curing One Patient at a Time.