Site Monitoring Services:

Lotus Clinical Research Academy Pvt. Ltd. (LCRA) offers clinical monitoring services for clinical trials and BA/BE studies.We have a team of monitors headed by a  Project Manager & our monitoring services are governed by well defined SOPs and monitoring plans for each study.

LCRA has already monitored more than 80+ studies for submission to various Regulatory authorities like US FDA, EMEA, and Health Canada etc. 

Monitoring services for clinical trials include:

• Site assessment and feasibility
• Key personnel training
• Planning investigator meeting
• Site qualification & initiation
• Development of monitoring plan
• Preparation of interim and final monitoring visit report
• Site close out
• Closing monitoring report with sponsor

BA/BE Monitoring Services:

• Clinical monitoring of the Study
• Bioanalytical Monitoring – for MD/MV phase

Our Team:

• Pool of 06 monitors + 01 Project Manager
• Team members trained on GCP
• Monitored more than 80+ BA/BE studies till date for various regulatory submissions
• Involved in monitoring an large multicentric trial in India

We also provide trained resources to be placed at investigator sites for the conduct & for the entire duration of the clinical trial.