Your product’s clinical strategy is an overarching master plan that guides the actions to achieve the long term aim of the product. It is driven as well as drives the reimbursement, and marketing strategies.
The clinical strategy
✔️ Gives you a competitive advantage, by bringing your device to market faster and supporting distinctive claims with well-founded clinical evidence.
✔️ Addresses specific regulatory requirements and relevant clinical research questions to be able to support clinical claims.
✔️ Fuels the reimbursement plan with the clinical evidence (e.g. the difference in diagnosis/treatment leads to an improvement in clinical outcomes) that can be used to justify reimbursement decisions.
✔️ For medical devices is developed in tandem with the device during the distinct phases of product development as design decisions might influence both risk management and claims.
“Execution is the ability to mesh strategy with reality, align people with goals, and achieve the promised results.”Larry Bossidy
The clinical development plan
The clinical strategy takes the form of a clinical development plan. The clinical development plan’s components (In general all biopharmaceutical products will need all of these components. For medical devices it is dependant of type and intended use):
- Literature review
- Individual trial design(s)
- Endpoints selection
- Investigators selection
- Target patient population
- Data collection points
- Appropriate statistical methods
Ultimately a well-defined and properly thought out clinical strategy will ensure regulatory approval, attainment of maximum reimbursement, successful market launch, and market adoption.
KW Advisory has extensive experience designing numerous clinical development plans and working with study sponsors to conduct research at sites best able to support the specific pharmaceutical and medical device from entry into clinical development through product launch and real-world evidence generation.
Clinical Advisory Services include:
- Global clinical strategy development including reimbursement, regulatory and marketing considerations
- Protocol development assistance: consultation on study designs, endpoints, and objectives
- Scientific and medical oversight of on-going trials
- Management of key opinion leaders and scientific advisory board
- Advisory consultation (includes discussions with the relevant team and stakeholders and/or review and inputs into the relevant following documents):
- Clinical evaluation report
- Protocol design and development
- Investigator brochure
- Instructions for use
- Case report form
- Informed consent
- Site selection
- Investigator meetings
- Clinical trial agreements
Contact Us at firstname.lastname@example.org to discuss further.