IND/CTA/IMD White Papers & Case Studies

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

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

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. Pharmacovigilance Monitoring Services 1/18/2012
   Norwich Clinical Services offers comprehensive pharmacovigilance services for pre-marketing product safety, post-marketing surveillance and data analysis.
4. 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