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To ensure the timely delivery of the necessary supplies, a sponsor must have a strong clinical packaging strategy that takes into account the most important details of its clinical study design. These details encompass the intricacies of logistics, distribution, staffing, patient recruitment, patient adherence to therapy, and regulatory compliance. The goal is to be able to respond appropriately to any surprises or issues that could not only jeopardize your study but also potentially delay your product’s development and launch.
With the price tag of bringing a drug to market recently estimated at nearly $2.6 billion, getting your clinical supply strategy right can be the difference between bankruptcy and survival for some companies.
The key details needed to develop your clinical packaging strategy include:
- Study size and enrollment rate
- Timeline and duration of clinical study
- Dosing configuration
- Drug storage temperature
- Label and package considerations