• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Clinsys Enters EDC Niche

Clinsys Enters EDC Niche

December 8, 2008
CenterWatch Staff

One company’s bad luck became another’s good fortune with Clinsys Clinical Research’s recent acquisition of a new electronic data capture (EDC) platform, TrialStat ClinicalAnalytics (TrialStat CA).

Clinsys, a contract research organization (CRO) headquartered in Bedminster, N.J., was originally looking at TrialStat to be the CRO’s vendor for EDC software, but before the contracts or negotiations were finalized, Clinsys ended up owning the platform.

“[Trialstat] ended up, quite frankly, going into receivership, and we had the opportunity to pick this up at a very, very reasonable price,” said Clinsys CEO David Williams.

Clinsys’ parent company, Jubilant Organosys, acquired TrialStat CA for about $610,000. The acquisition will enable Clinsys to expand its EDC services, as well as market the software to other CROs and pharmaceutical companies as a stand-alone EDC product.

“We keep a very strong firewall between Clinsys the CRO and Trialstat Clinical Analytics so that our sponsors feel comfortable that their data from another CRO is not being shared with us,” Williams said.

TrialStat CA will become Clinsys’ proprietary EDC system for phase I through phase IV studies. Along with the physical software, Clinsys acquired 18 support people based in Ottawa, Canada, who helped develop the EDC platform and will continue with project and data management and customer support.

With offices in the U.S., Germany and India, Clinsys will grow EDC’s services through the CRO’s existing networks and will expand its call service coverage to 24 hours a day, seven days a week.

“We intend to utilize the strength that we have in India…so that our sponsors will have total coverage around the world wherever they are, at any point in time,” Williams said. Clinsys will increase its India employee base (currently at 175) as well as the new TrialStat office in Canada.

Before this acquisition, many studies conducted by Clinsys—similar to the rest of the industry—were paper-based. Clinsys will continue to offer paper-based studies at sponsors’ request, but Williams predicted that the popularity of paper-based studies will wane as sponsors experience the efficiency and cost-savings of EDC platforms like TrialStat CA.

“I think that this whole SAAS technology, which is essentially called ‘software as a service’ technology, is something that really is the wave of the future, and I think you’re going to see a lot of platforms developed using that technology. We’re really at the forefront of that, so I think that’s a good place for us to be at this point in time,” Williams said.

In addition to the TrialStat CA platform, Clinsys will continue to offer Medidata’s Rave as an EDC platform.

“There are some studies that [Medidata] is ideal for, there are some studies that [Trialstat] is ideal for…and we’re happy to continue to do that,” Williams said. “We have, up to this point, been somewhat EDC system agnostic because we work on several different platforms that our sponsors have.”

Upcoming Events

  • 06Jun

    Gene & Cell Therapy Regulation: Comparability and Other New Developments

  • 07Jun

    Developing World-Class SOPs: Optimizing Quality and Compliance

  • 08Jun

    Implementing ICH E8 R1 Recommendations Increases Site and Participant Relationship Scoring Measures

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • MAGI East 2023

    MAGI East 2023 Preview: Janssen Reports on Environmental Impact of Trials

  • Complexity-360x240.png

    Phase 3 Trials Significantly Rising in Complexity, Says CSDD

  • Quality Level Scale

    Build Quality into Trials Like You’d Build a House, Says FDA’s BIMO Director

  • DE&I

    Trust-Building, Community Connection Still Essential to DE&I Efforts, Experts Say

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing