Strategic Planning

  • Clinical Development Plan
  • Protocol Design
  • Timelines

Safety Services

  • Safety reporting assistance (SAE and UADE)
  • Monthly/quarterly safety report preparation
  • Committee establishment and oversight (e.g., Data Safety Monitoring Board)

Research Compliance & Regulatory Services

  • Auditing (e.g., vendors, GCPs/sites, trial master files)
  • Regulatory submissions, report writing contributions

Clinical Services

  • Document preparation (e.g. informed consent forms, study templates/logs, study plans)
  • Case report form design and development
  • CRO and vendor evaluation, selection, management and closeout
  • Committee establishment and oversight (e.g., Steering Committee, Clinical Events Committee
  • Site Selection and/or oversight including budget/investigator agreement negotiations
  • Training (e.g., in-house staff, site study staff, investigator meeting)
  • Project Management
  • Medical Monitoring (review SAE and pregnancy reports, Med Hx/ConMed/AE coding reviews, answer protocol questions as required)
  • Monitoring/site management and/or report review
  • Data analysis, interpretation, and presentation
  • Final study report preparation

Additional Services

  • Staff recruitment
  • SOP development and/or revisions
  • External training
  • Personnel management (in-house and field associates)
I have worked with Allison for the last 3 years and I can say you will not find a better Clinical Trials Manager than her. She is very knowledgeable of her SOPs, Regulations and the entire Clinical Trial Process. She is a great team player and leader. Her colleagues love her enthusiasm and positive attitude.
— Paul Mastoridis, Pharm.D. Vice-President Medical Affairs at Mylan Specialty, Division of Mylan Pharmaceuticals