LASER ANALYTICA has cutting-edge knowledge and experience in the development and analysis of observation systems, using electronic health care databases (eHCD), electronic medical records (eMR) and its own unique resource (PGRx), to investigate:
- Impact of medicines and health technologies on drug and resource utilization
- Comparative/relative effectiveness of medicines & health technologies
- Relative risk and continuous benefit-risk of pharmaceuticals
These studies are conducted in a variety of contexts to inform decisions such as:
- Post-authorization efficacy/effectiveness studies (EMA’s PAES & FDA Post marketing commitments)
- Post-authorization safety studies (EMA’s RMPs & FDA REMS)
- Continuous benefit-risk assessment
- EU HTA dossiers and US payers
- Coverage with evidence development
- Market access evaluations
- Rapid response to alerts and crisis management
These services are served by the reliance on our advanced pharmacoepidemiology, data management and statistical teams.
e-HCD & eMR
Selected experience with eMRs & eHCDs
- US – Medstat, Premiere, Ingenix, Ford Health System, LabRx, others
- UK – CPRD, THIN
- France – EDB
- Canada – RAMQ, Saskatchewan, Ontario
- Germany – BKK sickness funds databases
- Netherlands – PHARMO
- Denmark – National eHCD (psychiatry)
- Sweden – National eHCD
- Multiple disease specific registries
Pharmacoepidemiologic General Research eXtension (PGRx)
Real world datasets for multiple purposes
No. 1 datasets for continuous benefit-risk assessment now available forHEOR studies & performance assessment
First developed for the study of the safety and risk of medicines, PGRx datasets were rapidly applied to the study of the comparative effectiveness of drugs in the prevention of morbidity and mortality outcomes. They now also incorporate information of special interest for health economics and payers’ decision purposes.
Case-based data for risk & effectiveness assessment
PGRx datasets allow in-depth analysis and regulatory-grade studies, as part of RMP, REMS, Continuous Benefit/Risk assessment, Post-Authorisation Safety Studies (PASS), Post-Authorisation Efficacy Studies (PAES), Coverage with Evidence Development (CED) or rapid response to alerts. PGRx data were used for pioneer continuous benefit-risk assessments and are the No1 primary data collections cited for that purpose on the ENCePP site.
New data for HEOR studies and decisions
Data collected by PGRx also provides in-depth information for the study of treatment pathways, clinical decisions, and patient journeys useful in predictive modeling, bridging studies, population impact assessment, cost-effectiveness studies, budget impact and other economic appraisals. PGRx data were used for pioneer outcome- based performance plans and provide a unique opportunity to expedite market access
Both medical & patient data
The only datasets to offer a possibility of follow-up and linkage
Using standardised data collection tools that have been validated in multiple studies, the PGRx Observation System offers a unique opportunity for obtaining extremely high quality data in real time, combining both medical information and patient reported outcomes
Data are collected from medical records and/or directly from physicians, providing detailed information on diagnoses and associated subconditions, laboratory tests, imaging and other diagnostic procedures, medication use and other healthcare resources.
A unique feature of PGRx data is that a linked subsample of patients are surveyed directly through autoquestionnaires or interviews on their drug use, adherence to treatment, including OTC drug use, personal history, risk factors, quality of life and outcomes. Patient consent allows follow-up and linkage to electronic records from other sources.
Datasets in multiple therapy areas
PGRx licenses data from our networks of centers across Europe and North America, maintaining data collection in multiple therapy areas. More than 20 disorders are presently available in PGRx, from a dozen therapy areas. The list is constantly up-dated and increased in response to need.
With PGRx Real World Datasets we commit to deliver:
- Fast, real time data: the PGRx System provides data in a few weeks on almost any disorder or clinical sub-population, thereby allowing rapid responses to any information need
- Credible data: PGRx provides high specificity of disease diagnosis and uses only validated questionnaires on patient reported outcomes and drug use
- Ethical data: PGRx data collection being approved by ethics committees, and samples collected in respect of epidemiological principles, the data can be used for peer-review publications and reports to health authorities
- Powerful data: because only cases of interest are collected, and with a high positive predictive value on all parameters considered, the PGRx datasets are as powerful as very large databases or surveys that eventually provide only a few really relevant sets of data.
- Efficient data: the costs of PGRx data is fixed and includes all expenses and fees, including investigators’ fees. The multiple users of the system, and sometimes of the same data, allows very significant savings.
*The PGRx trade name belongs to Lucien Abenhaim and Lamiae Grimaldi. The use of the systematic case-referent methodology is on free access.