Clinical Regulatory Document Writing for Submission.

Our Leadership

CHRISTOPHER CUSUMANO, B.A.

Senior Director, Quality Control

Chris’s knowledge and understanding of clinical and statistical data as well as his keen attention to detail and ever present communication skills have established his reputation as Senior Director, Quality Control (QC) at PreciseDox. With approximately 30 years of experience spanning clinical research (data management, Clinical Research Associate, and Clinical Research Manager) and document QC, Chris has an exceptional reputation for timely and thorough document reviews. He has performed QC reviews of regulatory clinical documents in numerous indications for various NDA/BLAs. Prior to becoming a QC professional, Chris worked in clinical research for a few different organizations (Memorial Sloan Kettering Cancer Center as Data Coordinator; Research Triangle Institute as Regional Data Monitor; Sanofi Winthrop as a Clinical Research Scientist and Manager; Precision Research, Inc. as Clinical Research Manager). As the Senior Director of Quality Control at PreciseDox, Chris is the primary document QC reviewer for all PreciseDox projects. He manages the QC projects in accordance with client timelines and works closely with internal QC staff, independent subcontractors, and medical writers, both in-house and client based, to ensure production of the final document

Our mission is to consistently produce precise and timely clinical regulatory documents that assist pharmaceutical and biotechnology organizations with developing new and promising therapies.

INTEGRITY is the guiding principle behind our decision-making process and the work we produce.

We value open and ongoing COMMUNICATION both internally and in our client relationships.

We respect and encourage COLLABORATION within our internal organization as well as with our clients.

We have an unwavering DEDICATION to our clients to produce high-quality documents in line with client timelines.

Our ADAPTABILITY is key to continue providing effective client support in an ever-changing regulatory environment.

As an organization, we promise to provide accurate and timely documents. Consistently.