Feasibility Studies White Papers & Case Studies

1. Phase I-IIA Clinical Trials Brochure 5/29/2013

   At INC Research/inVentiv Health we have the ability to expedite clinical programs and build the foundation for continued development of the product.

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. New Molecular Entities (NMEs) - The Path Of Resistance 5/3/2013

   On a global scale, the number of new molecular entities (NMEs) in development—and, more importantly, the number being approved by regulatory authorities— has dropped significantly in recent years.

4. eTMF And The eClinical Universe 2/21/2013

   How Electronic Trial Master Files (eTMFs) Work With Other eClinical Systems To Help You Meet Regulatory Requirements.

5. 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.

6. 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.

7. Strategic Clinical Outsourcing Considerations: The Interdependency Of Clinical Drivers 1/15/2013

   A solid outsourcing strategy is critical to leading your organization to a successful outsourcing experience. Of course every organization in need of outsourced services must consider their priorities: Is it cost? Timelines? Team experience? Some combination? Inevitably the salient considerations are a combination of each of these factors, yet some will be weighed more heavily than others. By Kevin Boos, RDP Clinical Outsourcing, Scott Connor, Acurian, and Meenal Patel, RDP Clinical Outsourcing

8. Phase II Primary Insomnia Program In Need Of Full-Service CRO Management 12/6/2012

   Clinilabs, a contract research organization (CRO), was selected by an international drug discovery and development company to provide full-service CRO management of a phase II primary insomnia program.

9. 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.

10. Supporting Multiple Registries With A Single System 5/22/2012

    Registries are created for a wide range of purposes that include such goals as recruiting patients for clinical trials, tracking treatment plans for tumor boards, determining study feasibility, conducting retrospective chart reviews, and evaluating outcomes.