Regulatory Insights

  1. Catching Up With The Consumerization Of Technology In The Clinical Trial World

    Not too long ago, a clinical operations professional likely enjoyed more powerful technology capabilities at the office than at home. She had a sophisticated email infrastructure, shared calendaring, a high-speed network and maybe a Blackberry.

    At some point during the last 15 years this trend flipped. Suddenly people had better tools in their personal lives and the limitations of their office tools became apparent by comparison – for example, systems that won’t talk to each other, small inbox quotas, file size attachment restrictions, slow email searches and difficult file sharing. Meanwhile, consumer technology rapidly became more sophisticated, available and accessible with collaborative cloud-based tools, personal devices and similar applications to improve the efficiency of everyday tasks.

  2. The Plain Writing Act of 2010: Lessons for Industry

    FDA and other federal agencies are bound by the Plain Writing Act of 2010 to use “clear government communication that the public can understand and use.”  It seems ridiculous that we’d need legislation for such a thing, since “understandable” and “useful” are such obvious and fundamental attributes of communication.  There’s even a companion document, the 118-page Federal Plain Language Guidelines (FPLG). By Laurie Meehan, Polaris Compliance Consultants, Inc.

  3. Expediting Companion Diagnostic Development Through Collaboration

    August 2011 cemented a remarkable two months for companion diagnostics, with the FDA posting draft guidance on companion diagnostics in July and then approving two cancer drugs and their accompanying tests weeks later. Zelboraf® and the BRAF mutation test for patients with metastatic melanoma were approved August 17, and Xalkori® and the corresponding Vysis ALK Break Apart FISH Probe Kit, which detects gene rearrangements, were approved just nine days later.

  4. Patient Reported Outcomes: A Key To Compliance Success Factors

    Subject compliance is a hot topic in the industry right now. Some of the discussions out there can be a little misleading since ‘compliance’ means different things to different people / companies.

  5. PhlexEview: Transforming Costly Paper Processes Into Value Driven Compliance

    This paper discusses some of the challenges of traditional paper-based TMFs and provides details about PhlexEview, Phlexglobal’s eTMF system. It also suggests a new approach to TMF compliance that extracts and sets the expectation for continuing value from TMF content, rather than locking it away in paper storage where its value is minimized. By Karen Redding, Global Business Development Director, Phlexglobal, Ltd.

    PhlexEview supports compliance and collaboration by leveraging industry standards and making TMF content available to users, regardless of their location. The ability to access and view TMF content at any time transforms sluggish and inert paper processes and helps organisations to realize time and cost savings by reducing travel costs, positioning team members to proactively identify compliance issues and implement corrective actions and by facilitating global collaboration.

  6. Benefits Of Non-Clinical Scientific And Regulatory Support For Late Phase Studies

    This case study illustrates how robust non-clinical advice and consultancy can expedite and accelerate drug development and increase the likelihood of regulatory acceptance
    for development programs.

  7. Eight Best Practices For Compliant Essential Site Regulatory Documents

    In the push to initiate clinical trials, activating sites is understandably the primary focus—leaving essential site regulatory documents as a secondary priority and a bit of a “necessary evil.” Indeed, most sponsors and CROs approach essential site regulatory documents as a check-the-box exercise. By Patrice Pompa, Director, Regulatory Document Management Services and Kevin T. Williams, MBA, MS, Vice President, Corporate Development and Marketing, CFS Clinical

  8. Regulatory Approval Of Clinical Studies In The Netherlands

    The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands. 

  9. Global Biosimilar Development

    Inconsistency in nomenclature used for biosimilars has led to confusion in referring to some products.

  10. End-To-End Management Of Clinical Trials Data

    The introduction of electronic data capture (EDC) systems in clinical trial data management and analysis triggered the promise of better-managed clinical trials – with greater efficiency, faster access to higher-quality clinical data and better mapping of data flows to business processes.