To ensure the best possibility for an asset’s success and avoid potential setbacks, each step of the drug development and commercialization process, from discovery through loss of exclusivity, must be strategically planned. Evidera provides a team of experts that provides end-to-end regulatory, clinical development, and value and access consulting services that span all phases of development. With over 30 years of experience, our team of clinicians, scientists, analysts, and consultants provides a wealth of diverse knowledge that can provide insight as stand-alone engagements or serve as an ongoing extension of your team.
Strategic Regulatory Consulting
Creating a detailed, pre-clinical plan with an eye toward later stages of development for your asset is vital. Our non-clinical, regulatory experts specialize in developing plans that satisfy the needs of regulators to move a product to the clinic and beyond.
Our expertise spans a wide range of product types and routes of administration with services including:
- Evaluating technical data including chemistry/manufacturing, pre-clinical, and clinical
- Designing and managing programs
- Determining the appropriate regulatory procedure and legal status for products
- Designing protocols; monitoring studies; and providing scientific oversight, data interpretation, and report reviews
- Proposing optimal filing and submission strategies
- Performing gap analyses
- Writing non-clinical sections of investigational new drug (IND) applications, clinical trial applications (CTA), marketing authorization applications (MAA)
- Ongoing contact with regulatory authorities to facilitate compliance
Strategic Clinical Development Consulting
Our clinical development consultants are experts in the design and execution of full product development programs. With access to a range of internal experts including physicians, biostatisticians, and clinical scientists, our team can help design a clinical development plan that reduces risk and maximizes clinical success. Our services include:
- Cross-functional, integrated product development plans
- Minimum and target product profiles and associated clinical development plans
- Clinical trial design
- Adaptive trial design
- Protocol development and optimization
Strategic Value & Access Consulting
With rigorous, evolving, and heterogeneous health technology assessment and payer evaluation criteria, challenging price negotiations, and a dynamic competitive environment, drug and device developers need to prepare their market access strategy early in the product lifecycle to ensure optimal access. Our expert team of industry leaders, former payers, policy experts, and experienced strategists can help you navigate complex evidence requirements and anticipate and overcome payer barriers to help you achieve optimal price and access.
Value & Access Offerings
- Global pricing and market access strategy and roadmaps
- Value and evidence strategy and planning
- Integrated scientific advice for evidence generation optimization
- Payer advisory boards and engagement plans
- Value story development and testing
- Cross-functional team alignment through market access workshops
- In-licensing decision support
- Strategic development and implementation for country-specific pricing and reimbursement
- Value and launch support through our excellence framework
In-Depth Experience Across Specialties
Strategic Value &
Access Consulting
Drive and demonstrate payer value throughout the development lifecycle to maximize a product’s success in today’s competitive market
Strategic Regulatory &
Clinical Development Consulting
Effectively plan for and overcome any challenges your product may face from discovery through approval with a customized plan that increases efficiency, reduces risk, and maximizes your product’s value
Value & Development Consulting Resources
Value & Development Consulting Experts
