Clinical
Clinical Strategy
Clinical Development Plan
The Clinical Development Plan defines the clinical pathway your company will take on the road to Marketing Applications.
Target Product Profile
A Target Product Profile is critical to defining the ultimate vision of your product, sets the criteria for success across internal functions, and is a critical part of a Clinical Development Plan.
Integrated Development Plan
An Integrated Development Plan is an overall product development plan that integrates all activities required for Marketing Application.
Study Design
A successful study design will address the requirements of the Clinical Development Plan and the Target Product Profiles.
We can help your company design efficient clinical trials to accelerate your development process while still addressing internal and/or external requirements.
Protocol Development
Our experts can translate a Study Design into a working Protocol Synopsis and then into a full Protocol.
Due Diligence
We provide assessment of medical need and feasibility of a proposed development strategy including the regulatory and clinical aspects.
Clinical Leadership Oversight
Our clinical experts can assume Leadership roles within our client’s organizations to help them drive their team’s success from strategic planning to implementation
- Project Development Team Leadership
- Clinical Program Leadership
- Clinical Director
- Study Team Lead
Clinical Execution Oversight
Our clinical experts can help our client's oversee execution of clinical trials
- Trial Initiations and Closeouts
- Data Review and interpretation
- Safety Review
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