NDA/BLA/MAA White Papers & Case Studies

1. 33 Questions To Ask Before Buying Data Management Software 4/30/2013

   While choosing the wrong product is never a good idea, when it comes to clinical trials software, the wrong product could be disastrous for your company.

2. 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.

3. Identifying Products For Drug Development Programs 10/5/2012

   A generic drug company always targets the introduction of its generic drugs when the reference product comes off patent. A generic cliff has it looking for alternative revenue sources.

4. Therapeutic Expertise: Neuroscience & CNS Datasheet 3/27/2012
   PRA is a leader in the clinical research industry, providing innovative solutions for CNS drug development.
5. 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.
6. 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.
7. White Paper: Understanding the 505(b)(2) Approval Pathway 8/5/2011

   Explore how the 505(b)(2) regulatory pathway can help drug developers gain approval for new drugs in a fraction of the time and cost required by traditional paths.