Integrated Scientific Advice

Our Solutions Clinical Development PPD Evidera Health Economics & Market Access PPD Evidera Market Access Integrated Scientific Advice

Cohesive evidence generation for regulators and HTA bodies

There is an increasing desire from regulators and health technology assessment (HTA) bodies to provide insight to pharmaceutical and biotechnology companies earlier in the drug development process, allowing better alignment of evidence needs for both regulatory approval and market access. While early engagement from regulatory agencies is standard practice, scientific advice from HTA bodies is a relatively recent addition that is rapidly gaining momentum, particularly, with the new European Health Technology Assessment Regulation.

Integrated Scientific Advice is a systematic approach to seeking regulatory and HTA scientific advice procedures employed by an integrated, cross-functional team

Benefit both access and pricing with ISA

Understanding in advance what your stakeholders want and require can save you substantial time, effort and cost by allowing you to plan effective evidence generation and deliver quality results. The many benefits of ISA include:

Early formal testing of aspirational value propositions and proposed evidence
De-risking the clinical development program by better understanding the expectations of regulators and payers
Internal alignment of stakeholders to effectively manage multiple evidence requirements
Minimizing duplication in evidence generation activities
Reducing time to HTA decision and patient access
Informing price range testing following feedback on the value proposition
Early understanding of evidence requirements for pricing models and managed access

Get ahead with an integrated and experienced team

Optimize your evidence generation plans to develop robust evidence that is relevant to all stakeholders (patients, clinicians, regulators, HTA bodies and payers) and supports timely patient access. Our integrated team provides evidence-based support combined with tailored project management to ensure timely delivery of a robust HTA package that maximizes the efficiency, quality and impact of ISA engagement.

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HTA scientific advice engagements

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Integrated regulatory and HTA advice engagements across 10+ companies

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Regulatory scientific advice engagements

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Indications in ISA engagements

Gain ISA strategy and implementation support

Integrated regulatory and HTA support Streamline regulatory and market access review with fully integrated submission support, including strategic consulting, real-world evidence, health economics, and HTA and regulatory consulting.

Senior expertise with former HTA committee members Leverage insights from senior team members, including veterans of HTA bodies such as NICE, with vast experience attending scientific advice meetings and HTA committee meetings.

Extensive regulatory and HTA scientific advice expertise Advance with confidence knowing your team has deep knowledge of HTA submission requirements, integrated scientific advice and extensive experience developing submissions for global HTAs.

Prominent role in industry methods development Trust you are in good hands with experts who have taken a prominent role in developing guidelines for industry methods, including ISPOR-SMDM modeling, ISPOR MCDA guidelines and guidelines for database selection in pharmacoepidemiologic research.

A collaborative approach

When working with clients, we take a comprehensive, collaborative approach that is customized to each client’s needs. This includes four key phases, with core processes in each to support integrated scientific advice, plus optional tasks tailored to meet specific identified goals.