NDA/BLA/MAA White Papers & Case Studies

1. Signature Requirements For The eTMF 2/19/2013

   Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision-making, we’ve researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.

2. Therapeutic Expertise: Neuroscience & CNS Datasheet 3/27/2012
   PRA is a leader in the clinical research industry, providing innovative solutions for CNS drug development.
3. Endocrinology Services Brochure 3/15/2012
   A leading western CRO in Russia, ClinStar offers invaluable experience and strong medical backgrounds to enhance your study execution, resulting in higher-quality results. We offer local regulatory, customs and logistical expertise, as well as clinical teams that are therapeutically trained in endocrinology.
4. White Paper: Foreign Clinical Trial Data 8/5/2011
   Given the high cost of moving a promising drug candidate through years of clinical trials, it’s no wonder that more and more drug manufacturers have begun conducting at least some of their clinical trials in foreign countries. With lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, but especially to those involved in generic and “fast-track” approval programs.