Overview
Bespoke service in Pharmacoepidemiology
While larger pharma companies may have in-house pharmacoepidemiology expertise, many small to medium companies don’t have this facility. DSRU Consulting can fill this gap.
Observational studies and big data are becoming part of the pharmaceutical scene. They are used in a wide range of areas, from pharmacovigilance (their original home) to health technology assessment and clinical development (including regulatory approval).
We have been conducting observational studies and using real world data since the 1980s. We can collect our own data in both primary and secondary care, as well as having access to established data sources.
Case Study
We provide advice and hands-on support in pharmacoepidemiology, including planning and conducting observational studies.
- We were contacted by a small generics company with a pharmacovigilance team of two
- They needed to propose PASS studies to the regulators but didn’t know how to go about it
- We discussed the parameters with the company to establish the indication, population and questions to answer
- We agreed to provide advice under DSRU Consulting and offered a price-capped package in recognition of their restricted budget
- We consulted expert prescribers of the drug in order to understand prescribing behaviour and to propose realistic sample sizes and study timescales
- The DSRU Consulting team deduced the best data sources to use to study safety and utilisation in primary vs secondary care, calculated the required sample size and time frame for the studies
- We provided outline protocols to the company for a CPRD study and a hospital-based study based on our SCEM methodology
- The company were happy with the advice provided by DSRU Consulting and requested that the DSRU team conduct both CPRD and hospital studies
Key features
- Access to an experienced team of epidemiologists, physicians and data scientists – not just a lone consultant.
- The DSRU Consulting team has decades of experience in developing and conducting observational studies
- We have an in-depth understanding of regulatory requirements
- We can provide advice only or can plan and conduct an observational study as necessary
- We can work with you to refine your requirements regarding observational data sources
- We provide either advice on a case by case basis or can be retained to provide continuous support
- As a non-profit organisation, the DSRU service is very good value
