Project Management White Papers & Case Studies

1. SynteractHCR Full-Service CRO Brochure 3/4/2016

   SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.

2. 10 Insider Tips For eCOA Implementation 1/8/2016

   If your organization has yet to adopt the use of eCOA (electronic clinical outcome assessments) in your clinical trials, then this white paper on successfully implementing the use of this technology should be of interest to you.

3. CROs And The Clinical Supply Chain – It’s Not Just A Label On A Box 11/3/2015

   Typically Clinical Research Organizations (CROs) involvement in the clinical trial process has centered on site management in terms of identifying potential sites and managing patient recruitment. They also offer services related to activities such as protocol development, data management, laboratory services, and toxicology analysis amongst others. Managing clinical supplies has always been seen as a backroom activity, one which sponsors tended to keep a firm hold on, perhaps highlighting their importance to the sponsor in terms of meeting First Patient In (FPI) deadlines.

4. Bioanalytical Development Services Brochure 5/29/2013

   INC Research/inVentiv Health provides high quality bioanalytical services across the entire continuum of drug development. Our significant experience with small and large molecules, peptides, immunochemistry, LC/MS/MS, HRMS, GC/MS/MS and ICP-MS, combined with having one of the largest capacities in the industry, allows us to blend innovative science with effective, validated processes to deliver quality data on time, every time.

5. Sourcing For Savings Case Study 5/29/2013

   To help the client overcome these challenges, INC Research/inVentiv Health formed a strategic partnership with the biopharmaceutical company and took over responsibility for all of its trial-level clinical data management activities in the United States.

6. 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.

7. 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.

8. Phase II Alzheimer's Case Study 5/29/2013

   A double-blind, Phase II, placebo-controlled clinical trial to evaluate the safety and efficacy of a novel compound in subjects with mild to moderate Alzheimer’s disease.

9. Phase IV Clinical Trials Brochure 5/29/2013

   INC Research/inVentiv Health Late Stage leaders help world–class companies bridge the gap from development to commercialization.

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

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