Regulatory Insights

  1. FDA’s December 2012 Guidance On IND And BA/BE Reporting – Part I

    FDA published in December 2012 a final guidance on IND and BA/BE reporting along with a brief Q&A accompanying it. By Bart Cobert

  2. FDA’s SOP For FDA’s PV Inspectors

    In December 15, 2012 FDA issued its updated Chapter 53 on Postmarketing  Adverse Drug Experience (PADE) Reporting Instructions. This is part of FDA’s Compliance Program Guidance Manual but is, in reality, more or less an SOP for FDA’s inspectors. By Bart Cobert

  3. Source Documents And Data Retention In Drug Safety

    In late November 2012, FDA released a new draft guidance entitled “Electronic Source Data in Clinical Investigations”. By Bart Cobert

  4. The Sunshine Act: Physician Payment Sunshine Provisions

    The Sunshine Act requires manufacturers of drugs, devices, biologicals, and medical supplies to begin recording all physician payments—including payments made for clinical trial research

  5. Guidance For Industry eSource Documentation In Clinical Investigations

    The FDA is encouraging electronic source data for clinical investigations. This presentation looks at the intentions of the guidance, related regulations and guidelines, understanding new clarified definitions, and what this new guidance means to DATARAK and other EDC vendors being eSource compliant.

  6. Grant Payment Practices: Five Requirements For Stronger Investigator Relationships

    In the clinical trials industry, profitability and regulatory compliance pressures continue to mount. Consequently, pharmaceutical companies are striving to maximize their research and development spending by reducing clinical trial cycle times and focusing on their core competencies—all while maintaining high standards of quality. By James M. Dicesare and Kevin T.Williams, Clinical Financial Services, LLC (CFS).


  7. eClinical Trial Auditing Quality & Compliance

    Effective auditing of eClinical trials provides objective evidence to sponsors and supervisory agencies that trial data has been collected according to established policies and procedures safeguarding data quality, security and privacy. In this article, PHT Director of Quality Management & Compliance Rod Thorell and Laura Araujo, Senior Consultant of Quality Management at Halloran Consulting Group, discuss the importance of auditing, explain how it is conducted, and review contemporary issues of auditing. By PHT Corporation

  8. Ever Considered Mobile Nursing For Your Clinical Trials?

    Mobile nursing for a clinical trial is performed by a qualified nurse at an alternate location (home, office, vacation) requiring the same data quality and subject safety as on site visits. By offering mobile visits for clinical trials, the site can see improvement in patient recruitment, patient retention and compliance, expanded geographic reach and increased subject convenience.

  9. Connecting The FDA And Pharma/Biotech Industry
    Even with more than 8,800 employees and an annual budget of around $3.2B, the FDA’s task of protecting the public health seems daunting, considering the complexity of products being developed by industry. By Rob Wright
  10. Patient Compliance, ePRO And The Role Of The Care-giver

    Sponsor companies are increasingly required to employ methods for patient-reported outcomes (PROs) that ensure timely, accurate and attributable data collection, as well as to improve patient compliance.