Pharmacovigilance System Review
Optum provides SOP development for companies setting up their pharmacovigilance systems. Audits of existing systems and gap analyses are also typically done. If you’re partnering with another company for pharmacovigilance, we can help develop Pharmacovigilance Agreements and conduct audits.
Optum provides training for clients on pharmacovigilance, including customized courses developed at the request of the client.
Clinical Trial-Related Pharmacovigilance
Expedited reporting for clinical trial-related adverse experiences is routinely done in Canada, the United States and Europe. IND Annual Reports or Clinical Trial Annual Summary reports are also routinely developed.
Marketing Application-Related Safety Documents
Optum routinely develops Application-Related Safety Documents including a Summary of Clinical Safety for Common Technical Documents, Integrated Summaries of Safety for the FDA, NDA Safety Update Reports, or Responses to 80-Day, 120-day, or 180-day reviews.
Medical Information: We provide medical information services for the Canadian and U.S. markets. Services are provided in English and French through a 1-800 number specific to an individual client. Our call centers typically answers phones during business hours, but 24/7 coverage can be provided on request. A log of all calls, by product, is maintained and provided to clients monthly. Calls are answered by a health care professional (pharmacist).
- Global and Local Literature Screening: Optum can help you comprehensively and cost-effectively manage your literature screening requirements. Our medical librarians screen Medline, Embase, journals not covered in these databases, and local literature weekly, and provide their findings to our clients. We identify Individual Case Study Reports (ICSRs), and develop CIOMS forms including case narratives, MedDRA coding, and medical assessment. All serious national and international reports are submitted as expedited reports. Cases are archived in our ARISgTM database. Additionally, we can carry out searches for the purpose of signal evaluation or identifying safety concerns for inclusion in PSURs.
- Individual Case Summary Reports (ICSRs): Any suspected adverse reactions are forwarded from our call center to the Pharmacovigilance Department. International cases are forwarded to the client’s Safety Mailbox. Adverse reactions are logged into our ARISgTM database; CIOMS or Medwatch forms are generated; and MedDRA coding, seriousness assessment, and expected assessments are done, as required by the client. For New Drugs, Canada also requires that unusual cases of lack of efficacy be submitted as expedited reports, and cases from our Medical Information Department are also screened for this.
- Aggregated Report Development: PSUR reports are prepared according to ICH requirements and filed with regulatory agencies as per regulatory requirements. Reports similar to PSURs are also routinely developed, including Canadian Annual Summary Reports and U.S. Periodic Adverse Drug Experience Reports.
Contact Anne Tomalin at Optum: 1.866.722.6734