BioCelerate CRO Virtual Roundtable

NonClinical Protocol Template Initiative

BioCelerate is developing a protocol template meant for first-in-human enabling, repeat-dose general toxicology studies, which it intends to make publicly available for free to anyone who wishes to use it. Having a common template will help minimize cost, errors, and improve operational efficiencies during the interpretation and execution of studies. It is important to the project team to make sure CRO feedback is included in the development process. We are planning a CRO Virtual Roundtable in which we will review the draft protocol template, aiming to generate discussion around formatting and content with all those involved.  The roundtable is free of charge to all participants. 

Not Available for this date?  If you are interested, but not available for this date, please complete the registration form and select YES in the Consenting Box to be notified of upcoming activities related to the development of the BioCelerate Nonclinical Protocol Template to provide input in the future. 

Roundtable Objectives:

  • Overview of the initiative
  • A review of the current repeat-dose general toxicology protocol template developed by BioCelerate, highlighting specific sections where CRO feedback is encouraged. 
  • Open discussion on challenges CROs experience with implementing a harmonized template

Target Audience:

Nonclinical CROs: CROs are most experienced in dealing with the nuances of protocol development across multiple Sponsors, and nonclinical CRO feedback would be incredibly valuable to the BioCelerate initiative.

August 22nd 2019 from 08:00 AM to 10:00 AM GMT -5

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Please click the "Register now" button below to register for the roundtable. 

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