Your objective is clear: bring new drugs to market faster, more efficiently and at a lower cost. To do this you must navigate the challenging waters of the clinical trial process. A key success factor during clinical trials is to ensure the clinical trial supply chain process works extremely well.
The management of clinical trial supplies covers a broad range of critical and complex tasks:
- Demand forecasting
- Raw material acquisition
- Drug production
- Packaging and labeling
- Distribution to clinical site trials
- Coordination with investigational parties
- Distribution to patients
- Patient replenishment process
If your organization partners with Contract Manufacturing Organizations (CMOs), the success of your clinical trial supply chain is even more dependent on effective collaboration with these important business partners. But other complexities also exist.
Clinical trials typically lack long-term stability data, so most investigational studies must contend with the logistics of short expiration dates for the drug. Patient enrollment often comes in multiple waves, some patients do not complete the study, and new patients enroll to replace those who left the study. While these dynamics further compound the challenge of accurate production forecasting, having sufficient supply to meet the demands of the study is essential: running out of stock will jeopardize the validity of the entire study.
Regulatory and Globalization Constraints Also Exist
FDA and EMEA regulations apply at every point along the process. Geographically dispersed studies add to the challenges. AMR Research reports that between 2006 and 2010, the number of clinical trials conducted in North America and Western Europe will fall from 55% of all studies to just 38% as more investigational work is conducted in China, India and Africa. Despite these challenges, study parameters must nonetheless be respected, including randomization protocols, blindness standards, and drug environmental parameters. Finally, patients need access to customer service representatives or an integrated voice response system to initiate the replenishment process. Replenishment orders must be filled accurately: the right drug must go to the right patient at the right time, every time.
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