Medical literature is an important source of information on suspected adverse reaction case reports. As regulations are becoming more stringent, marketing authorization holders (MAHs) may face the challenge of incorporating ever-increasing safety data from literature into their pharmacovigilance (PV) efforts to achieve compliance. The quality and efficiency of the literature monitoring process has a significant impact on the quality of periodic safety reports, detection of new safety signals and eventually benefit-risk evaluation (BRE) of medicinal products. Importantly, shortcomings in this critical process have the potential to impact the MAHs overall PV activities including Regulatory compliance and potential impact on company reputation due to inadequate BRE of company products leading to potential drug recalls.
As part of PV surveillance process, Freyr assists organizations with specialized literature monitoring services to overcome the challenge of monitoring literature. Right from Signal assessment to Individual Case Study Reports (ICSR) to Periodic Safety Update Reports (PSUR) to Medical Literature Monitoring (MLM), Freyr’s team ensures the safety is monitored all through.
Freyr is specializedin Literature monitoring services for:
- Signal Assessment
- Aggregate Report/Periodic Safety Reports
- Single point of contact for the entire range of safety services including ICSR, Aggregate reports, Qualified Person Responsible for PV (QPPV) services, the US Agent services, Signal Detection & Evaluation, database migration, adverse event reconciliation, and local affiliate services
- Initial kick-off to submissions to HA and handling/addressing HA queries
- In-depth safety knowledge perfectly integrated with required IT capabilities
- Expertise in ICSR case management including case triage/book-in, case processing, narrative writing, medical review, quality control and submission
- Staff with hands-on experience in handling/managing standard and customized safety databases like Aris G, Oracle Argus, Adverse Event Reporting System (AERS), FDA's AERS (FAERS), SCEPTRE, Empirica Trace, Sapphire, Clintrac to name few
- Expertise in writing aggregate safety documents as per various HA and submission requirements like Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSURs), Periodic Adverse Drug Experience Report (PADERs), Annual Safety Report (ASRs), Risk Management Program (RMPs), Risk Evaluation and Mitigation Strategy (REMS), any other country specific reports, etc.
- Expertise in setting up PV systems and processes, PV Database Evaluation, PV Database Validation, Harmonization, writing SOPs and training employees as per local Regulatory requirements in various geographies
- Experience in conducting mock audits, training on facing inspections, support in preparing Corrective and Preventive Action (CAPA) and remediation activities
- Extensive experience in PV process harmonization and creation of Company Core Data Sheet (CCDS) and Core Safety Information (CSI)
- Experience in tracking safety variations and PV System Master File (PSMF) compliance
- Defined processes of thorough scientific, medical, editorial and quality control review
- Timely delivery with the highest standard of quality
- Expert program and project management support to maintain compliance