Data 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. What The Fitbit Is Helping Pharma Learn About Patients 2/22/2016

   Fitness trackers were popular holiday gifts this year and sales are on the rise. While counting steps and getting fit may be the primary reason consumers are purchasing Fitbits and other wearables, other sensors these devices include, such as heart rate and sleep monitors, could actually help big pharma collect a wealth of valuable data to revolutionize personalized medicine.

3. 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.

4. When Your Timeline Is Cut Short On A Global Data Management Project 9/17/2015

   PRA Health Sciences performed data management activities for this project while the client was responsible for all other services, including site monitoring. When the client reduced the timelines for database lock by approximately 9 months, PRA immediately created a detailed closure plan, listing all tasks and activities that required completion within the given timelines. This plan was reviewed and approved by all parties involved. To successfully complete the closeout period, PRA calculated data flows and trained additional staff members.

5. Electronic Drug Accountability Sytems In Clinical Trials 3/30/2015

   Ensure drug compliance, safety and data integrity in clinical trials with electronic drug accountability systems.

6. Electronic Informed Consent: Considerations For Implementation In Clinical Trials 2/23/2015

   In an era where data acquisition (eg. ePRO), capture (EDC) and storage (eTMF) are done electronically, it is the logical consequence to do the same for the informed consent process as all the advantages of the electronic modality equally apply to this process.

7. Clinical Trial Recruitment Managers Can Be More Efficient And Reduce Costs 9/13/2013

   This case study analyzes Accel Clinical Services, its challenges associated with their CTMS system and the results achieved via the implementation of Bio-Optronics’ clinical trial management system.

8. 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.

9. Eight Best Practices For Compliant Essential Site Regulatory Documents 5/21/2013

   In the push to initiate clinical trials, activating sites is understandably the primary focus—leaving essential site regulatory documents as a secondary priority and a bit of a “necessary evil.” Indeed, most sponsors and CROs approach essential site regulatory documents as a check-the-box exercise. By Patrice Pompa, Director, Regulatory Document Management Services and Kevin T. Williams, MBA, MS, Vice President, Corporate Development and Marketing, CFS Clinical

10. End-To-End Management Of Clinical Trials Data 5/16/2013

    The introduction of electronic data capture (EDC) systems in clinical trial data management and analysis triggered the promise of better-managed clinical trials – with greater efficiency, faster access to higher-quality clinical data and better mapping of data flows to business processes.