ACL Digital’s PV unit is equipped to receive and process initial and follow-up reports of individual Adverse Event cases (Individual Case Report Processing) via a Safety database (e.g., Oracle Argus).
Our team is also trained in Medical and Scientific Literature search, identification and categorization of Adverse Events for assigned drugs, expedited or periodic reporting, Medical Reviews and Aggregate Reporting involving collective analysis of cases in the database. Aggregate Reports offer a broader view of the safety profile and risk-benefit evaluation of a drug.
PV Services include
- Expertise in innovator drugs, generic pharma, biologics, biosimilars, high-risk medical device
- Therapeutic Area experience: Oncology, Cardiovascular, Neorology, Orthopedecis, Endocrinology and Metabolic Disease, Gastroenterology, Immunology and Infectious Disease
- Dedicated PV professionals: Drug Safety Associates, PV Scientists, Risk Management Leads, Safety Leads, Medical Reviewers, experienced Safety Project Leadership
- Validated Safety Database hosting and maintenance: Oracle ARGUS, ArisG database
- Management of Safety Data Exchange Agreement (SDEA)
- Individual Case Safety Reports (ICSR)
- Coding of indications using Extended EudraVigilance Medicinal Product Dictionary (xEVMPD) and MedDRA
- Medical Device Reporting (FDA MDR)
- PV Literature Review and Monitoring: Refer to section on DIGITAL SERVICES AND SOLUTIONS
- Tracking of all PV compliance activities with corresponding Regulatory submission timelines
- Signal Detection and Management
- Risk Management Plan (RMP)
- Aggregate Reports: drafting, data review, Medical review, Regulatory submission (PADERs / PSURs / PBRERs / DSURs)