LA-SER is leading the way in the development and implementation of Risk Management and Benefit/Risk Management strategies, offering the best knowledge on drug-related risk issues, including risk assessment and sophisticated surveillance, risk perception, crisis management, as well as handling regulatory issues. In addition, our extensive experience in effectiveness studies, and real-world evidence of drug impact, is of cornerstone importance for the development of Benefit/Risk Management strategies and to conduct of related studies.
LA-SER approaches Risk and Benefit/Risk Management from two perspectives: Proactive Benefit/Risk Management and Reactive Rapid Response to alerts.
Risk assessment Studies
Risk management plans are individually designed and adapted to regulatory requirements. The relevant studies are conducted, including the full range of observational methods: active surveillance, PASS registries, electronic healthcare databases analyses, and several case-referent designs (case-control, case-cross over, case-cohorts) or case-time series. One of LA-SER’s key strengths is the unique PGRx methodology, that we developed, and apply worldwide.
Pharmacoepidemiologic General Research eXtension (PGRx™)
LA-SER has developed an innovative solution for the study of infrequent or delayed events potentially associated with drug use. This unique approach uses a systematic and simplified case-control methodology, known as the PGRx System.
Cases of incident diseases are collected from networks of clinicians in several countries. The diseases studied are either too infrequent to be easily found in most automated databases, or too difficult to diagnose with certainty to rely only on usual codes available in such databases. Also, PGRx is of help when it is important to document individual risk factors that may confound the association between exposure and disease or when the delay between exposure and disease occurrence is too long to be captured in most electronic records.
PGRx for Active Surveillance and Rapid Response to alert
Often initiated at the occasion of a particular study, the collection of cases is pursued on the long term, at least at a minimal level, to ensure a constant availability of networks to be mobilised, in case of any other alert. This approach, for instance, allowed us to be the first to implement a surveillance of H1N1 vaccination and Guillain-Barré syndrom, using our accessible networks and data collection tools. These tools include:
- Web-based clinical report forms adapted to the constraints of epidemiology research, user friendly, and requiring minimal clinician time.
- The ascertainment of exposure to drugs through guided telephone interviews and prescription records (obtained from physicians, pharmacies or by linkage to claims databases).
- A large sample of potential referents constantly recruited in each country, from which controls can be selected to be matched to cases.
More than 300 medicines meeting one of the following criteria are systematically tracked and evaluated:
- Newly marketed molecules (<3 years)
- Drugs targeted in risk-management plans
- All vaccines
- OTC drugs
Recent PGRx Studies
PGRx has been used to address requests from the EMA and other regulatory bodies. The activities of the PGRx System are reviewed by an international scientific board.
Web-based Monitoring & PASS Registries
LA-SER has extensive experience in web-based registries, acquired first through its PGRx experience, with web-based disease registries, and extended to PASS registries. We systematically tailor-fit the collection of data, for the problem at hand. Thanks to our extensive experience, web-based data collection tools are usually developed in 2 weeks or less.
Using training webinars for physicians, distance collaboration and all modern technology resources, as well as our 4 internal call & interview centres (based in Montreal, London, Paris and Rabat), we are able to monitor registries in more than 15 countries worldwide. More than 12 languages are spoken at LA-SER, by at least one physician or pharmacist, enabling us to relate efficiently and professionally to clinicians: English, French, Deutsch, Spanish, Portuguese, Italian, Arabic, Russian, Armenian, Hungarian, Polish, Swedish, Hindi, Gudjurati.
We provide PSURs using MEDRA coding and other services upon request.
Electronic Health Care Database Studies for Risk and Benefit-Risk Management
We have more than 25 years experience in using electronic health care databases (eHCD) for risk assessment. We were amongst the first users of the Saskatchewan database, the former ‘VAMP Research’ (now GPRD) database, the RAMQ database, PHARMO and others as soon as in the late 80s and early 90s, we have developed our knowledge and experience to a large array of databases worldwide, including eHCD from the US, Canada, UK, France, the Netherlands and others.
PROTECT
LA-SER-PGRx participates as a SME in the IMI-funded PROTECT programme of the EMA, as a member of WorkPackage 2 and the leader of WorkPackage 6. The latter consists in identifying sources of data for the assessment of methods developed in the former (and in other packages). A catalog of a hundred databases has been established.
