Due Diligence is critical before dedicating precious time and resources to a research project that appears to hold commercial promise. Due Diligence is typically performed by investors but can, and should, be conducted by sponsors. Doing so increases their chances of financing success, partnering, mergers and acquisitions (M&As), and product licensing. For companies developing multiple products, Due Diligence can also inform and assist in deciding which products to budget for as part of portfolio management.

What is Due Diligence in clinical research?

Sponsors request third-party Due Diligence involving R&D assessments to increase investors’ evaluation in the current competitive market. Due Diligence is a systematic way to analyze and mitigate risk from a business or investment decision.

• Clinical Due Diligence involves examining the disease selected based on the product MOA, the clinical plan, and Ph 1 & 2 synopses, including the patient selection and the inclusion/exclusion criteria. The sponsor’s proposed clinical plan and study design are benchmarked against the competition.
• Regulatory Due Diligence involves understanding the product and the therapeutic areas to evaluate the sponsor’s regulatory strategy completeness and risks.