Outsourcing Preclinical Development Management, and Monitoring in India

Project Management and pro-active Study Monitoring is an essential component to ensure success of an outsourced contract research project. ClinTech Research's designated project manager in the USA will work closely with your study team to manage your study timelines and to ensure two-way communication through a single-point-of-contact in the USA.

Monitoring outsourced GLP toxicology studies from USA to India is a cumbersome, time consuming and challenging. ClinTech Research develops and implements outsourced preclinical study monitoring programs for drug development companies in the USA which enable them to access the GLP-compliant preclinical infrastructure facilities in India while maintaining the Quality and Compliance oversight obligations on behalf of our sponsors.

ClinTech Research is able to provide GLP-compliant Toxicology & Safety Pharmacology services that include preclinical project management and monitoring of these studies. Our vendor-independent preclinical study safety monitoring services in India ensures that preclinical study meets the requirements for US FDA, ICH, OECD GLP guidelines Specific preclinical project management & study monitoring services include:
Prepare Preclinical Safety Plan according to Protocol and GLP guidelines

Develop detailed Project Plan with activities, timelines and resources, including critical milestones and key decision points in the program

Vendor-independent preclinical safety monitoring in India

Prepare, review, and edit the preclinical monitoring report

Peer review of histopathology findings/reports done by CROs in India

Manage the client/vendor relationship by monitoring vendor progress and keeping the client informed including troubleshoot technical issues