Regulatory Solutions

  1. CoSign Digital Signatures

    Strict regulations, such as the FDA's 21 CFR part 11, require organizations in the life sciences industry to guarantee the authenticity, integrity and confidentiality of electronic records.

  2. Safety Technology

    From smart, technology-driven products like our hosted Oracle Argus safety database, Oracle Interchange, Oracle Argus Insight, the Transperfect Trial Interactive safety portal, the UL Eduneering Training platform, EDC integrations, electronic data migrations,  EasyCode™ Dictionary Management Tool and more to expert-infused services that deliver validation, CFR 21 Part 11 compliance, a technology support desk, system upgrades,  and resolution to functional gaps to improve safety work flows, Sentrx’s Technology Services Group always delivers two essential outcomes: confidence and trust.

  3. Control GMP Content And Prevent Revenue Loss In Life Sciences Manufacturing

    Life sciences organizations face more pressure than ever to run efficient, uninterrupted manufacturing production at the lowest possible cost. To stay compliant with government regulations, quality and manufacturing organizations must precisely follow Good Manufacturing Practices (GMP) standardized processes and maintain an associated document control process that adheres to those requirements.

  4. UX Training™ - Learning Management System Datasheet

    DATATRAK’s UX Training™ product manages training of any kind for anyone in a compliant environment. 

  5. Electronic Clinical Outcome Assessment (eCOA) Solutions

    CRF Health is a global leader in innovative electronic Clinical Outcome Assessment (eCOA) solutions that attain unmatched patient and site acceptance and consistenly deliver industry leading compliance rate of more than 90%.

  6. Contract & Regulatory Services Brochure

    With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones—including drug shipment, IRB approval, and patient randomization—can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents.

  7. eSP™: Electronic Short Path Software Platform Brochure

    Quick protocol configuration and enhanced study compliance, through eSP software’s clinical protocol predicted events and testing requirements, shorten deployment time.

  8. Document Management and Regulatory Compliance Solutions

    FirstDoc, EMC’s preferred Regulatory Compliance Solution for Life Sciences, is the proven document management and collaboration solution on Documentum that integrates with SharePoint.

  9. Adverse Event Reporting, Safety And Compliance Software

    Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it’s also incredibly labor-intensive.

  10. Document Management Software,compliance

    The DocuShare Compliance Module is an ideal solution for any organization seeking to provide control over electronic documents and their associated business processes.