Clinical Trials Department Establishment & Management

End-to-end setup and operational management of clinical trial departments at hospitals and research sites. Establishing a robust Clinical Trials Department is foundational for ethical, efficient, and compliant research, as outlined in ICH GCP E6(R2) Section 4 (Investigator Responsibilities) and ICMR Ethical Guidelines for Biomedical Research (2017) on institutional infrastructure. Our service provides end-to-end support for hospitals, research institutions, and independent sites, ensuring alignment with NDCT Rules, 2019 (Schedule Y) and CDSCO requirements for site qualification.We specialize in cooperating with pharmaceutical, biotechnology, and medical device companies to conduct clinical research trials, integrate speedy patient enrollment solutions into clinical trials, and rescue delayed clinical trials/FDA submissions.

Practical Guidelines and Support

Infrastructure Planning

Assess and design facilities per ICH GCP 4.1 (adequate resources) and ICMR recommendations, including dedicated trial space, secure storage for investigational products (IPs), and IT systems for electronic data capture (EDC) compliant with 21 CFR Part 11.

SOP Development

Create tailored SOPs for study initiation (ICH GCP 5.6), subject recruitment (NDCT Rule 19), safety reporting (ICH GCP 4.11), and close-out (ICH GCP 4.13), with version control and annual reviews.

Workflow and Compliance Frameworks

Implement risk-based monitoring plans (ICH GCP 5.18) and quality management systems (ICH GCP 1.65), including Ethics Committee (EC) integration and sponsor agreements (NDCT Rule 18).

Ongoing Management

Quarterly performance audits, KPI tracking (e.g., enrollment rates per ICMR metrics), and process optimization to integrate trials into hospital workflows without disrupting patient care.