Article: A Logistics Model for Tomorrow
By World Courier |
Logistics design for global cell and gene therapy trials
A logistics partner working with cell and gene therapies must achieve quality beyond compliance with GxP and cGMP adherence to address existing regulations and prepare for the unexpected.
In the world of ultra-sensitive therapeutic transport, precise planning is essential to assure that quality. Every detail must be accounted for before bio-materials enter the supply chain.
When considering a logistics partner, find out about their project planning model. At World Courier, the planning process prioritizes a truly customized service solution. Stages include:
Part 1: Assessment
The project’s cross-functional logistics team:
- identifies deliverables, milestones, performance and communications protocols
- learns the clinical team expectations based on past experiences/performance and current needs
- evaluates reasons for any earlier successes and failures
- collects necessary information from service providers
- communicates regularly with stakeholders
Part 2: Design
The creation of a detailed design of program components and their associated timelines, drawing on previous experience and the client’s unique requirements.
The result? A flexible solution that takes into account specific needs.
Part 3: Implementation
Next the logistics team develops and coordinates:
- process workflows, policies, procedures, study-related SOPs and work instructions
- recommended routings, transport mode, flight data, pick-up times, etc., capturing data from client software
- data reporting and analytics
- logistics staffing and, if necessary, recruiting
- training for all participants: clinical teams, investigators/site personnel, external suppliers, logistics personnel (including dedicated customer service), transport agents, brokers and
- meetings with Customs and key airline partners to raise program visibility and reinforce its importance to patients
Part 4: Pre-Operation
In our final preparatory step, the logistics team:
- solidifies communications, objectives, timelines, deliverables and scope among stakeholders worldwide
- launches study-specific 24-hour live support staffed by subject-matter experts
- sends test shipments
- provides additional client support and advice
- implements training and outreach;
- schedules regular follow-up with the client after the program launch to review execution and identify potential problems
- takes corrective actions as required
There is an incontrovertible connection between flawless planning and success that prevails in this context. To learn more about selecting the best logistics partner for your cell or gene-therapy study or as you move towards commercialization, please download our new e-book.