I–IV
Clinical Trial Phases Supported
6
Core Therapeutic Focus Areas
25+
Years of Biotech-Focused Development
CRMG is a nimble clinical development services organization, focused on providing biotech and pharmaceutical companies with an assortment of capabilities tailored to support clinical development programs and studies from Phases I – IV.
Our organization's foundation was built on our formative experiences in biotech, which allows our clinical and medical professionals to understand what it's like to sit on our client's side of the table, and to use that experience and knowledge to help plan and execute your study in a highly collaborative environment.
Our experienced teams have expertise across a wide array of therapeutic categories, with particular strategic focus in the following key areas:
MoreAreas of Focus
CRMG's vision from its inception has been to create a clinical consulting and research organization that focused on the needs of the biotech sector. We strive to be more than a service provider, but rather a partner that provides guidance on your study design, with the ability to operationally execute and deliver your trial against challenging timelines.
Learn What Makes Us Different
Integrity, Quality, Knowledge, and Passion. The cornerstones of success in life are the core of our business. Our mission is to deliver these key elements to each of our sponsors regardless of size, without exception.
Stephen Cincotta
President & CEO
Phase IIIB Diabetes Study
A sponsor approached CRMG with a first-in-class diabetes drug that was initially denied approval by the FDA. The FDA required a large safety study be performed, given concerns over cardiovascular risks for the product.
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Critical TMF Rescue Study
Based on our reputation for quality and attention to detail, a biotech organization approached CRMG to provide rescue trial master file (TMF) support for a large, global Phase III study. Upon an audit of the TMF at the sponsor's…
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Phase II Renal Study
A Sponsor approached CRMG regarding a Phase II study of a novel phosphate binder previously approved for use in end stage renal patients on dialysis. The Sponsor's objective was to generate data to support expanding the label claim for this product to encompass chronic kidney disease (CKD) patients not on dialysis.
read more >We are proud of our successful track record and the partnerships that we have created with our sponsors, with many programs leading to NDA submissions and approvals.