IND/CTA/IMD White Papers & Case Studies

1. Marketing Application Submission Services Brochure 6/23/2015

   Biopharmaceutical companies’ marketing applications must present the history of their unique development programs and provide renewed hope for patients seeking safe and effective therapies. PRA Health Sciences has the necessary experience to deliver comprehensive marketing applications (NDA, BLA, MAA, etc) across all therapeutic areas and in all regions.

2. Regulatory Approval Of Clinical Studies In The Netherlands 5/16/2013

   The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands. 

3. Streamline And Accelerate A Drug Development Plan Using The 505(b)(2) Pathway 2/19/2013

   An international pharmaceutical company approached Camargo Pharmaceutical Services to help navigate the Food and Drug Administration (FDA) 505(b)(2) approval pathway for a promising drug under development designated for patients with cardiovascular disease. Product X is a prodrug that is converted in one metabolism-dependent step to produce the active metabolite of an approved drug.

4. 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.

5. 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.

6. Pharmacovigilance Monitoring Services 1/18/2012
   Norwich Clinical Services offers comprehensive pharmacovigilance services for pre-marketing product safety, post-marketing surveillance and data analysis.
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.

8. Human ADME & Studies With Radiolabeled Compounds

   During clinical drug development there can be several situations where the use of radiolabeled medication or other radiolabeled compounds is required or favorable to accomplish the study objectives. This whitepaper is mainly focusing on human ADME studies and “microdose” studies to assess absolute bioavailability (BA). The major part of the information in this overview is also relevant for other clinical studies with a radiolabeled compound. By Ad Roffel and Henk Poelman, PRA Health Sciences