---
title: Managing preclinical programs into Phase I/II clinical trials
description: Operational Support
---

[Case Studies Archive - Alacrita ](https://www.alacrita.com/case-studies)

# [Managing preclinical programs into Phase I/II clinical trials](https://www.alacrita.com/case-studies/managing-preclinical-programs)

 Written by [Cort](https://www.alacrita.com/case-studies/author/cort) | Nov 18, 2011 1:54:04 PM

## Challenge:

A leading cancer research charity needed project management and drug development expertise to shepherd two preclinical programs into Phase I/II clinical trials. Alacrita was engaged to provide an expert resource.

## Solution:

Our duties included overseeing the formal preclinical development program, submission of IND and execution of a Phase I/II clinical trial for two of the charity’s targeted therapy compounds. We were responsible for the following:

 

- identifying and negotiating contracts with appropriate CROs
- managing the CRO relationships
- identifying and overcoming issues as they arose
- ensuring regulatory compliance
- liaising with ethics committees
- monitoring and ensuring GMP compliance
- providing regular progress reports

[View full post](https://www.alacrita.com/case-studies/managing-preclinical-programs)

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