Clinical Studies

  • Clinical Study Design and Management in the USExperience in conducting global clinical trials by managing multi-functional international study teams in adherence to ICH Guidelines and other applicable regulations
  • Expertise in the design, feasibility assessment, and planning of single and multi-center Phase I-IV clinical trials
  • Experience in compiling and writing technical documents such as investigational drug brochures, protocols, informed consents, and clinical study reports
  • Experience in identification, qualification, and selection of clinical research organizations (CROs), core laboratory, clinical laboratory, and niche providers (e.g., data management services) against clinical trial needs
  • Experience in the management of institutional and commercial IRBs including submissions, document management, and query responses
  • Expertise in investigator identification, qualification, selection, training, and oversight
  • Expertise in qualifying, selecting, training, managing field based study monitors and medical monitors against clinical trial needs
  • Expertise in the creation of subject and study site staff instructions and data collection tools including the use of web-based, video, electronic, and paper formats
  • Expertise in the management of Data Safety Monitoring Boards, Steering Committees, Clinical Endpoint Adjudication Committees, including charter development
  • Expertise in requirements of 21CFR 312, 50 & 54, pertinent FDA Guidance, and Good Clinical Practice (ICH E6 Guidelines for GCP)
  • Expertise in creating and implementing Monitoring, Audit, Data Management, and Trial Master File plans
  • Expertise in investigational drug accountability procedures including for controlled substances