Real world data solutions for every need

Clinical trials are the mainstay for demonstrating the efficacy and safety of a product for regulatory approval; however, patient outcomes may differ when the product is used in clinical practice post approval. Therefore, sponsors rely on the analysis of real-world patient data to understand the ‘real-life’ effectiveness of their products. Real world evidence (RWE) has become important for regulatory decision-making as well, touching all areas of the healthcare value chain. Historically, RWE was used for post-market safety monitoring, but now pharmaceutical and biotech companies are beginning to use RWE data to support clinical trial design and observational studies to generate better treatment approaches, while healthcare systems are collecting and using RWE to substantiate coverage decisions.

Real World Data Solutions (RWDS) – A solutions oriented approach to RWE

Drawing on decades of experience, we offer real world data solutions for a variety of client needs across the pharmaceutical development pipeline ranging from RWE inputs into clinical trial design, regulatory strategy, external control arms, global and local market access needs, pricing and reimbursement (P&R) requirements and during market maintenance. Some of the typical research questions addressed are summarized below.

• Quantify Opportunity: Unmet needs, treatment patterns, burden of illness, market sizing
• Justify Access: Cost minimization, cost offsets, cost effectiveness and budget impact analysis, patient/caregiver/societal perspectives
• Measure Performance: Drug utilization studies, relative effectiveness, outcomes performance, Post-authorisation efficacy study (PAES)
• Ensure Safety: Benefit/risk assessment, risk management, signal detection, Post-Authorization Safety Studies (PASS)

Key elements of our RWDS projects can be classified into the following categories.