BGS Medical College and Hospital Conducts Site Initiation Visit for Multicentric Diabetic Foot Ulcer Clinical Trial

The Site Initiation Visit for the multicentric trial on Diabetic Foot Ulcer, by IPCA laboratories Pvt ltd was conducted at MEU Hall, 1st Floor, BGS Medical College and Hospital, Bengaluru, on 24th September 2026 from 09:30 AM to 4:00 PM. The SIV marked the formal initiation of study-related activities at the site and provided an opportunity for the site team and sponsor representatives to align on the study protocol, Good Clinical Practice (GCP), documentation requirements, investigational product handling, safety reporting, monitoring, and other operational requirements.

The inaugural session commenced by Dr. Malini, Head of the Department of Clinical Pharmacology, with a brief introduction. She highlighted the importance of ethical conduct, participant safety, quality documentation, GCP compliance, and coordinated teamwork in the successful conduct of clinical research at BGS Medical College and Hospital.

Study Team and Participants

• Principal Investigator (PI): Dr. Vijay B. Nagaraj

• Co-Investigator (Co-I): Dr. Tejas A.P, Associate Professor

• Head, Clinical Trial Unit: Dr. Dwajani.S , BGSMCH

• SMO: CEO, Leads: Mr. Jestin

• Clinical Research Coordinator (CRC): Ms. Anuja, Ms. Neethu and Mr. Bhanu

• CTN: Mrs. Dhanalakshmi

• Clinical Pharmacist: Ms.Navaneetha

• Sponsor Team: Sakshi Wandhare, CRA

The Site Initiation Visit provides the study team with an opportunity to establish a common understanding of study-specific requirements before and during initiation of study activities. The SIV strengthened coordination among the investigators, CRC, Clinical Trial Unit, Leads, and sponsor representatives, with emphasis on participant safety, protocol compliance, GCP, quality documentation, investigational product accountability, safety reporting, data quality, and monitoring readiness. The Department of Clinical Pharmacology serves as an important facilitator of clinical research activities at the institution. Through coordination, training, regulatory support, and oversight, the department supports the conduct of clinical studies in accordance with ethical principles, Good Clinical Practice, applicable regulatory requirements, and institutional procedures. The organization of the Site Initiation Visit reflects the department’s role in facilitating effective site readiness and coordinated clinical research activities. “Strengthening Clinical Research through GCP, Quality Documentation, Collaboration, and Participant Safety.”