Regulatory Solutions

  1. 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.

  2. 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.

  3. 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.

  4. Adverse Event Reporting, Safety And Compliance Software
    12/23/2011

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

  5. Document Management Software,compliance
    12/23/2011

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

  6. DocuShare Compliance Module
    12/23/2011

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

  7. Regulatory Affairs
    6/24/2011
    Our team of Regulatory Affairs experts plays a pivotal role in your project from initiation to completion, ensuring compliance with applicable laws and regulations throughout the process.
  8. ePRO Knowledge Center
    6/20/2011
    These published documents from the FDA and ISPOR support the use of ePRO in clinical trials.
  9. Regulatory Submissions
    6/14/2011
    Regulatory submissions are the most critical milestones in your clinical research program. Quality submissions can accelerate time to market, bring the benefit of new treatments to patients sooner, maximize research investments, and conserve patent life.
  10. Regulatory Affairs
    6/14/2011

    As the clinical development of new medical products becomes more complex, so has the route to regulatory compliance that ensures patient safety and regulatory compliance.