When a clinical trial goes global, a different mentality and philosophy must be applied in cross-functional working groups in your organization. From the clinical work at multi-national sites to data collection, read, and analysis, and even regulatory timelines, your trial must be designed in such a detailed and meticulous fashion to avoid change-in-scopes and other obstacles.
Medpace, your trusted and strategic partner for drug, biologic, and device development, has extensive experience with a global reach that can accelerate, expedite, and increase efficiency of your clinical development program. A few lessons learned from our experience and advantages that Medpace provides:
1) Think Globally; Act Locally – A broad vision is best, but having full time clinical and regulatory staff in the local countries is essential
2) Regulatory Headaches usually payoff – Some countries, such as Brazil, may scare sponsors due to the length and intensity of regulatory approvals and importation licenses. However, their “mega city” structure coupled with their patient populations provide a great location for a clinical trial.
3) It’s not about cost – Do not make decisions on countries due to cost. Perform a strong feasibility and go after countries where your desired populations are. It’s worth it.
We’re Medpace…and it’s a global thing.
Thursday, August 19, 2010
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