Regulatory Solutions

  1. CoSign Signature API (SAPI®)
    3/5/2013

    Signatures play a crucial role in our day-to-day lives. Organizations understand that paper processes are expensive and are looking to migrate from a pen on paper signature (wet signature) to a true paperless environment. CoSign allows organizations to easily meet this goal.

  2. 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.

  3. CoSign Digital Signatures
    2/27/2013

    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.

  4. Safety Technology
    12/21/2012

    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.

  5. Control GMP Content And Prevent Revenue Loss In Life Sciences Manufacturing
    11/21/2012

    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.

  6. UX Training™ - Learning Management System Datasheet
    10/11/2012

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

  7. Electronic Clinical Outcome Assessment (eCOA) Solutions
    8/30/2012

    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%.

  8. Contract & Regulatory Services Brochure
    8/29/2012

    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.

  9. eSP™: Electronic Short Path Software Platform Brochure
    4/27/2012

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

  10. Document Management and Regulatory Compliance Solutions
    12/23/2011

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