IRB White Papers & Case Studies

  1. Moving Towards An Electronic Environment In Clinical Trials 5/3/2013

    With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.

  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. Signature Requirements For The eTMF 2/19/2013

    Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision-making, we’ve researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.

  4. Strategic Clinical Outsourcing Considerations: The Interdependency Of Clinical Drivers 1/15/2013

    A solid outsourcing strategy is critical to leading your organization to a successful outsourcing experience. Of course every organization in need of outsourced services must consider their priorities: Is it cost? Timelines? Team experience? Some combination? Inevitably the salient considerations are a combination of each of these factors, yet some will be weighed more heavily than others. By Kevin Boos, RDP Clinical Outsourcing, Scott Connor, Acurian, and Meenal Patel, RDP Clinical Outsourcing

  5. 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.

  6. Patient Major Depression Disorder Case Study 5/4/2012

    ePharmaSolutions, a global site activation and patient enrollment company developed and deployed a geo-targeted direct-to-patient outreach, education and recruitment campaign to augment enrollment for a Major Depressive Disorder program being conducted at 100 study centers in North America.

  7. MyTrialFinder Product Sheet 3/16/2012
    Beginning April 2012, clinical trial sponsors will have access to a new and innovative clinical trial patient recruitment approach: MyTrialFinder launches on WebMD.
  8. MyTrialFinder Product Sheet 3/16/2012
    Beginning April 2012, clinical trial sponsors will have access to a new and innovative clinical trial patient recruitment approach: MyTrialFinder launches on WebMD.
  9. Pharmacovigilance Monitoring Services 1/18/2012
    Norwich Clinical Services offers comprehensive pharmacovigilance services for pre-marketing product safety, post-marketing surveillance and data analysis.
  10. Employee-Driven Change Management Takes Copernicus Group IRB Completely Paperless 12/29/2011

    Copernicus Group IRB (CGIRB), with assistance from Sitrof and employee-driven change management, was able to transform from an entirely paper-reliant company with millions of pages of legacy documentation into a completely digital paperless organization in less than two years.