Value-Added Service
Real-World Data (RWD) Collection
How is Real World Data Collection Integrated into Access Programs?
Real‑world data collection must be incorporated into access programs in a way that does not inhibit patient access. This requires data collection that is focused, justifiable, of minimal burden, aligned with routine treatment and country‑specific regulatory requirements.
At Tanner Pharma, we manage RWD collection through a practical, compliance‑driven approach.
Data requirements are tailored by country and site to reflect regulatory expectations and participation realities, ensuring meaningful data is captured without delaying treatment or creating access barriers.
What Operational Factors Shape RWD Collection?
Spontaneous safety event capture is standard in access programs
Baseline patient data is typically collected before first shipment
Data collection is often aligned with shipment cadence
Efficacy data cannot be mandated outside a protocol
Site participation may require compensation
Tanner’s Strategic Recommendations
Keep data collection focused, valuable and justified
Sponsors cannot insist on RWD collection as a prerequisite for a patient
Anticipate variable HCP and patient participation
Consider compensating sites if data collection is critical
Optimize datasets by country or site, focusing on where the data is most valuable
Confirm regulatory agreement where required
Engage HCPs early in planning
Our Approach to Real-World Data (RWD) Collection
Keep data collection aligned with existing workflows
Maintain regulatory and pharmacovigilance compliance
Focus on meaningful and practical datasets
Protect patient access and treatment timelines