Integrated Evidence Generation Planning (IEGP)

Integrated Evidence Generation Planning (IEGP) is essential for enabling pharmaceutical, biopharmaceutical, biotechnology and medical technology companies in meeting the evidence needs of a range of key stakeholders, from regulatory bodies and healthcare providers (HCPs) to patients and payers. We customize our end-to-end IEGP approach to suit the specific internal processes of our client partners, ensuring we design a bespoke solution that helps maximize the value of scientific innovations and minimize risks throughout the product lifecycle.

In addition, we adapt our IEGP process for more specific evidence requirements as therapies become more specialized and focused on sub-populations and as evidence needs vary throughout the development and commercialization lifecycle.

Lumanity’s IEGP process is built on key principles that drive success:

Collaborative

We break down silos and align stakeholder needs across regions and functions – including Clinical, R&D, Regulatory, Medical Affairs, and Commercial – to coordinate actions and avoid fragmentation

Strategic Insight-driven

We leverage deep subject matter expertise to identify critical evidence needs for various stakeholder groups and translate complex data into actionable evidence

Early and Often

Engaging stakeholders early and often ensures that our strategies remain relevant and effectively address the needs of regulatory bodies, payers, HCPs, and patients throughout the product lifecycle

Our cross-functional IEGP framework is designed to support your organization from strategy development to evidence dissemination. Our approach harnesses specialist expertise from Lumanity’s medical strategy & communications, HE-HTA, real world evidence (RWE), clinical & regulatory, and market access teams to account for crucial perspectives and facilitate alignment with our client partners.

Our deep subject matter and medical strategy experts help translate complex data into evidence to support your value story:

• HEOR scientists, market access specialists, and regulatory experts identify key evidence needs to optimize regulatory review, access, and reimbursement
• RWE experts uncover evidence gaps, identify RWD sources to address them, and execute studies to generate RWE
• Global medical affairs and patient advocacy and engagement experts provide key insights into specific evidence needs across target audiences, including specialists, HCPs, regulators, payers, patients/patient advocacy groups (PAGs)
• Seasoned consultants advise on cross-functional alignment and help interpret stakeholder insights into your strategy to prioritize evidence needs