Strategic Clinical Trial Planning

At Harbor Clinical, we provide expertise to small/mid-sized biotech/pharma companies   to ensure the best possible outcomes of the clinical trials that are  crucial to their company’s success.  We provide subject matter experts across functional areas including quality assurance, vendor oversight, clinical operations, medical writing, regulatory, biometrics and strategic development. 

Our Strategic Planning capability is a great way to help your team ensure the best outcomes of your clinical development program.   By bringing in “outside eyes” who have been there and done that you can be confident that your planning is on point to achieve success.    Our biotech/pharma clients typically engage us when they:

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

At these key junctures, we can provide a variety of clinical planning activities at the molecule or portfolio level.  These often are:

• 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 plans to guide implementation/investment based on the planned portfolio.

We have numerous case histories and success stories where our team has provided critical benefits with strategic planning assistance to our biotech/pharma clients that we are happy to share with you.

If  you’d like to learn more, please fill in the form below and we’ll reach out to you to schedule a time to discuss your needs.