Phase II – IV Clinical Trials:

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.

We provide the following Clinical Research services:

Pre Study Services:

• Protocol, ICD and Trial Documents preparation
• CRF designing and finalization
• Regulatory Approvals
• Assistance with EC Dossier and Approval
• Randomization Services

Study Conduct Services:

• Site assessment and feasibility
• Site monitoring
• Development of monitoring plan
• Project Management which includes project compliance to ICH/GCP standards
• Investigator site training
• Investigator meetings and payments
• Quality Assurance
• Clinical data management
• Statistical services
• Clinical study report preparation and finalization

Post Study Services:

• Study close out
• Query Resolution
• Site follow up