Preparing to Partner with a Contract Research Organization: What you need to know for an effective and efficient relationship

Event description

Presenters: Sharon Daily, PhD

Approaching Contract Research Organizations (CROs) to perform necessary studies to aid your product's success can be a daunting task. Many investigators turn to the Catalyze technical team with questions like: What studies are needed to approach the FDA? What is a reasonable amount to expect to pay for a CRO's services? How do I know what services to request? Do I need to have a pre-IND meeting before, or after, hiring a CRO?

Join us for a webinar presented by Dr. Sharon Daily, an experienced professional in pharmaceutical development specializing in regulatory strategy of safety programs for drugs and biologics, where she will walk through the questions you need answer before approaching a CRO in order to have an efficient and effective relationship, and to ultimately set your product up for regulatory success. Dr. Daily will present several real-world cases as practical examples demonstrating why adequate preparation before approaching a CRO will save you time and money.

This webinar is the first in a three-part series that will provide practical advice with examples for medtech innovators preparing to hire a Contract Research Organization or Contract Manufacturing Organization (CMO). The next webinar in our series will focus on approaching and partnering with CMOs in January 2024. The series will conclude with a discussion about medical device-specific considerations when partnering with CROs/CMOs.

Webinar presented on November 8, 2023 to an invited audience.

This video is provided for educational purposes only.

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This research was, in part, funded by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.