First In Human White Papers & Case Studies

1. Considerations When Selecting A CRO For Phase I Clinical Studies 6/17/2013

   Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies. This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.

2. 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.

3. Recruiting Patients With Impaired Renal Function Case Study 5/29/2013

   According to FDA Draft Guidance published in March 2010, a pharmacokinetic (PK) study should be conducted in patients with impaired renal function when the drug is likely to be used in such patients and when renal impairment is likely to mechanistically alter the PK of the drug and/or its active metabolites.