Drug Development Consultancy
Building on a wealth of experience and specialized expertise, Aptiv Solutions enables sponsors to implement product development and drug development programs that are intelligently designed, cost effective and timely – while also taking into account the practical considerations of translating a plan into action. The Aptiv Solutions Product Development Consultancy (PDC) group has wide-ranging experience across all key elements required to build a robust drug development strategy. Our experience, gained through hands-on drug development and applied through our project team approach, provides clients with expert leadership and management in the development of therapeutic products.
From our offices in Europe and theUS, our PDC program management experts guide cross-functional networked teams in the conception, refinement and conduct of product development with a global perspective. Our understanding of the full lifecycle of product development and knowledge of the current landscape means we are well placed to explore and execute traditional and alternative development strategies. Our team-based and collaborative approach encourages efficient use of valuable resources and progression of projects in a wide spectrum of therapeutic areas.
Smart Drug Development
We believe that “smart” development is only possible by defining a clear product strategy starting from early phase consulting, designing a focused intelligent development plan, and careful planning and management of the implementation. Aptiv Solutions brings clients the expertise and experience of a full product team – with members chosen for their therapeutic area and drug development knowledge – to achieve this goal.
We have experience across a range of therapeutic areas with an emphasis on Oncology, CNS, Cardiovascular, Respiratory Disease, Inflammation, Endocrinology and Infectious and Rare Diseases. We also maintain close links with key opinion leaders and regulators.
Clinical Product Development Expertise
- Assemble team of internal and external experts appropriate to the project and to meet client’s needs
- Full development strategy designed in partnership with the client
- Engage key opinion leaders (KOLs) early and often
- Develop rational development plan
- Define clear decision points and contingency plans
- Ensure cross-functional collaboration
- Develop risk management and mitigation strategy
- Develop cross-functional project plans, budgets and timelines
- Provide routine status reports
- Monitor activities against project plans
- Maintain accountability within the project team
- Develop communication plan within the project
- Development of a target product profile to help meet scientific & funding milestones
- Selection and management of scientific & clinical advisory boards, including protocol design groups
- Due diligence