We’ll work with you to evaluate the correct level of RWD collection for your program, building this into our compliant program design. We collect the data in our 21CFR Part 11 compliant management system SMARThub®.
Alignment across functions in the sponsor company is key to RWD collection. The RWE generated may impact future clinical development programs, market access and commercialization strategies. That’s why we’ve developed a series of tools and processes to aid this discovery and alignment process.
One key question is what level of data should be collected. We use our experience in both data collection and physician/pharmacist engagement combination with your therapy and product knowledge. As a result, we can develop an attainable, robust RWD set that aligns with your objectives. This can then be used for further regulatory submissions or reimbursement discussions.
EAP will normally be run across multiple jurisdictions. Depending on your program there may be obligations or limitations on the level of RWD collected.
We use our regulatory knowledge and experience to develop compliant data sets in each country.
Our bespoke management system, SMARThub (Supporting Medicines Access in Real Time), allows us to collect data at any point in the physician or patient journey.
SMARThub is an innovative system for creating, collating and analysing bespoke data sets in a way that’s intuitive and 21CFR Part 11 compliant.