Regulatory Insights

  1. 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.

  2. 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.

  3. 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

  4. Regulatory Approval Of Clinical Studies In The Netherlands

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

  5. Global Biosimilar Development

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

  6. 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.

  7. Future Trends For Online EDC In Clinical Studies: INTrial© Application On PCs, Tablets and Smartphones

    The positive effect of electronic data capture (EDC) on the increase of data quality and on the decrease of time to generate clean data is well known. Today the question no longer is “Shall we use EDC instead of paper work?” but to gain insight in the advantages and pitfalls of the various solutions available.

  8. How NOT To Respond To An FDA Warning Letter

    Has your company received an FDA warning letter? A proper response is critical and may mean the difference between whether the FDA accepts your response or determines that additional action is required. When crafting your response, make sure you do not make a bad situation worse by engaging in any of these mistakes.

  9. Beyond EDC: Resolving Data-Entry Challenges Faced By Electronic Data Capture Systems In Clinical Trials

    Electronic Data Capture (EDC) systems have swept the Clinical Trials industry in recent years, promising to transform the drug development process.

  10. Military Drug Trials Group Eliminates Errors And Inefficiencies Using Electronic Data Capture And Tablet PCs

    Infectious Disease Clinical Research Program (IDCRP) is a worldwide network of Department of Defense (DoD) clinical and research centers that have collaborated to investigate infectious disease challenges facing the military.