Clinical Development Strategy and Planning
In formulating a successful clinical development strategy, pharmaceutical and medical device companies must consider not only the needs of regulators, but also anticipate marketplace expectations around product uniqueness and value.
DRG offers a range of services to clients seeking to develop, pressure-test, or fine-tune their clinical strategy
Experience and knowledge
DRGC has long-standing experience working closely with our clients' scientific, medical/clinical, and commercial teams in support of these goals. By leveraging our deep knowledge of unmet needs, treatment paradigms, and product development histories in multiple disease areas, our understanding of global regulatory requirements and trends, and our access to a broad range of influential stakeholders (including payers, regulators, and thought-leading physicians), DRGC provides insights - and data-driven recommendations that can help shape and sharpen development strategies and clinical study planning.
Over the last three decades, we have partnered with our clients on a broad range of projects, including overall clinical program planning and clinical development strategy, that is based on internal considerations (e.g., indication expansion strategy, franchise development) and external factors (e.g., regulatory requirements, endpoint selection based on competitive and reimbursement landscape) to specific product value proposition development and testing.
- Target product profile development & testing
- Detailed benchmarking: systematic competitor analysis, analysis of product strengths, weaknesses, gaps, and opportunities, clinical trials by indication, regulatory decisions
- Clinical and medical development strategy, including trial endpoints and designs (input from payers, prescribers, KOLs)
- Label analysis
- Regulatory landscape analysis