Clinical Operations 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. Financial Management With Clinical Conductor Site CTMS At Coastal Carolina Research Center 8/7/2013

   The Coastal Carolina Research Center began using Clinical Conductor Site CTMS in 2008.

3. 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.

4. 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.

5. Improving Life Science Operations With Digital Signatures eBook 2/27/2013

   Today, 8 of the top 10 pharmas and 6 of the top 10 CROs use ARX’s CoSign® digital signature solution to help them benefit from fully electronic regulatory document lifecycles, compliance with various FDA GxP regulations, and efficiency in supporting audits.

6. 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.

7. Grant Payment Practices: Five Requirements For Stronger Investigator Relationships 9/27/2012

   In the clinical trials industry, profitability and regulatory compliance pressures continue to mount. Consequently, pharmaceutical companies are striving to maximize their research and development spending by reducing clinical trial cycle times and focusing on their core competencies—all while maintaining high standards of quality. By James M. Dicesare and Kevin T.Williams, Clinical Financial Services, LLC (CFS).

    

8. Therapeutic Expertise: Neuroscience & CNS Datasheet 3/27/2012
   PRA is a leader in the clinical research industry, providing innovative solutions for CNS drug development.
9. PRA Exceeds Tough Enrollment Goals: Service Delivery Model Drives Positive Results 2/20/2012

   Changes in resources for both the client and PRA teams led to significant challenges with the start-up and enrollment activities in Europe and North America.

10. Fundamentals Of The Patient Recruitment Process: Better Recruiting For On-Time Studies 8/24/2011
    The leading cause of drug development program delays is the challenge of recruiting the right number of patients with the right qualifications. Patient recruitment continues to be ranked as the most costly and time consuming aspect of clinical trials. By Shaheen Limbada, Cetero Research