Drug Safety, Pharmacovigilance, and Risk Management

Our consultants can provide the expertise to assist in the development and management of your clinical and post marketed safety programs to ensure patient safety through efficient and effective processes.

Strategic Safety Consulting

  • Gap analysis and process improvement assessments
  • Strategic planning for growth of your safety department

AE/SAE Case Processing

  • Call Center Support, event data entry, logging and tracking, coding (MedDRA, WHO Drug), legacy case data entry, analysis of similar events, narrative writing, QCreview.

Physician Practice

  • Medical Review
  • Regulatory Response
  • Product Lifecycle Management
  • REMS, benefit risk assessments and risk management planning
  • Signal Detection and aggregate data review
  • Literature Reviews and summaries
  • Completion of Aggregate Reports
  • Preparation of Drug Safety portions of IND/BLA/NDA/ ad hoc reports

To learn more about our services, contact us today!

Toll Free: 1-866-879-1963

Phone: 781-569-0607

Fax: 866-915-6480

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