Strategic Clinical Trial Planning

INTRODUCTION:

Clinical trial planning is a critical activity for early-stage biotechnology companies preparing for
clinical milestones such as entry into the clinic or pipeline progression. Often the need for detailed planning activities arises in relation to investment decisions or asset development plans. Early-stage companies often need these activities before they have hired clinical staff. Typically, these companies have strong scientific and business teams but not the requisite clinical operations knowledge to develop robust plans that meet the expectations of company
executives and investors. Harbor Clinical is uniquely positioned to provide this
expertise.


WHO WE HELP:

Biotechnology/biopharma companies who:
1) have assets in the pre-clinical phase and planning to enter the clinic
2) have completed Phase 1 safety studies successfully and planning clinical
program expansion
3) have proof-of-concept clinical data and are planning for late-stage
funding/IPO or partnering with another company.


HOW DOES HARBOR CLINICAL HELP:

Clinical planning activities can be done at the molecule or portfolio level and typically include:
• Creation of a clinical development plan that outlines the various studies that will be needed to take a molecule(s) from initial safety testing through registration trials.
• Development of timelines for planned programs from entry into the clinic to regulatory filing as outlined in the clinical development plan.
• Budgets mapped to timeline by quarter/year.
• Resourcing plans to include internal staffing and vended services required as
the portfolio evolves.
• Clinical systems plan to guide implementation/investment based on the
planned portfolio.

Case Study:

Strategic Clinical Development Consulting

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