FEATURED ARTICLES

Breaking The Blind In Clinical Trials & Reporting To Health Authorities, Investigators & IRBs/Ethics Committees

This is a topic that has caused much consternation in pharmaceutical companies and has, in my experience, caused some clinical trials and even NDAs to fail due to an inadequate number of analyzable patients. By Bart Cobert

  • Considerations In Using Foreign Trial Data In U.S. NDA Submissions

    More and more drug companies are finding it financially advantageous to conduct clinical trials in foreign countries and to include data from these trials in NDA submissions. When offshore trials are properly conducted and the data is properly handled, this strategy can accelerate approval and lower the cost of drug development. By Ken Phelps, Camargo Pharmaceutical Services

  • Streamlining The Workflow of CRCs: Understand the Challenges, Provide Solutions

    Clinical Research Coordinators (CRCs) play a crucial role at sites in ensuring that research is conducted in a GCP-compliant manner. In many cases, processes could be streamlined to foster greater efficiency and quality in operations. In order to improve the processes, the challenges of current workflows must first be understood. 

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WHITE PAPERS & CASE STUDIES

  • Moving Towards An Electronic Environment In Clinical Trials

    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.

  • Improving Life Science Operations With Digital Signatures eBook

    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.

  • Signature Requirements For The eTMF

    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.

  • Strategic Clinical Outsourcing Considerations: The Interdependency Of Clinical Drivers

    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

  • 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.

  • Patient Major Depression Disorder Case Study

    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.

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SERVICES & PRODUCTS

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Study Start Up

One of the many challenges in conducting clinical trials is the speed to completion and finalization of essential and regulatory documents by the investigative site personnel.

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Institutional Review Board (IRB) Solutions

Whether you are a central IRB in North America or an IRB or Ethics Committee affiliated with a hospital, Trial Interactive has the ideal solution to streamline your processes.  

MyTrialFinder
Beginning April 2012, clinical trial sponsors will have access to a new and innovative clinical trial patient recruitment approach: MyTrialFinder launches on WebMD.
MyTrialFinder
Beginning April 2012, clinical trial sponsors will have access to a new and innovative clinical trial patient recruitment approach: MyTrialFinder launches on WebMD.
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NEWS

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