Clinical Monitoring 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. Overcoming Complexity On A Phase 2 Glaucoma Study 5/1/2015

   A Phase I/II multi-site study needed to enroll more than 100 patients across three distinct cohorts on an exceeding complex protocol.

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. 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.

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

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

7. 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.

8. Moving Towards An Electronic Environment In Clinical Trials 5/3/2013

   With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.

9. Global Pharmacovigilance And Safety Solutions 4/23/2013

   As the world’s largest privately held provider of global communication and technology solutions to the life sciences industry, TransPerfect offers an end-to-end solution to handle all aspects of pharmacovigilance and safety management in over 170 languages.

10. Overcoming Clinical Challenges In Metabolic And Cardiovascular Disease With Metabolomics 4/10/2013

    Metabolic diseases (e.g. obesity, type 2 diabetes, and hypertension) are a rapidly expanding health care concern. Although there is a high demand for novel therapies, the challenges are substantial as existing drugs typically fail due to lack of efficacy or safety, and clinical studies often extremely large and protracted.