Pharmaceutical Regulatory Affairs: Open Access

Kenneth A Getz

Publications

• Research Article
  Internal Facilitation Committees Improving Protocol Design Feasibility
  Author(s): Kenneth A Getz and Jennifer KimKenneth A Getz and Jennifer Kim
  
  Biopharmaceutical companies are actively seeking ways to simplify study design complexity and improve protocol feasibility. One new approach adopted by a growing number of companies has been to establish internal facilitation committees charged with evaluating the benefits and costs of various study design elements (e.g. volunteer eligibility criteria and protocol procedures). In late 2012, Tufts CSDD conducted in-depth interviews and compiled and analyzed profiles of internal facilitation committees implemented recently by ten major pharmaceutical. This article dis.. Read More»
  DOI: 10.4172/2167-7689.1000111

  Abstract PDF