Phase II- IV
Clinical Trial Phases - Further the Prospects of Path Breaking Diagnostics and Therapies
Lotus Lab exhibits leadership and a proven track record in the effective conduct of Clinical trial phases. The effective management of Clinical trial phases, is reflected in the fact that we have strategic relationships with reputed hospitals and have worked with over 200+ clinical sites across India. This ensures that we always have access to a large database spanning diverse therapeutic areas to effectively conduct Clinical trial phases that would eventually further the prospects of path breaking proprietary diagnostics and therapies.
Capabilities in Clinical Trial Phases
Lotus has rich experience in conducting multi-centric, multi-national clinical trial phases with patient groups ranging from 15 to 1500 for the USFDA. 15 sites of these have been inspected by the USFDA for the studies conducted through Lotus has conducted.
We have worked with over 1000 clinical sites in India, US and Bangladesh, where we have recruited over 7,000 patients for various clinical trials.
Our 360⁰ approach to Clinical trial phases ensures that sponsors benefit from the entire gamut of services:
- Investigator/Site identification and selection
- Regulatory and ethics committee submission
- Patient recruitment
- Project management and monitoring
- Data management
- Central Reference laboratory (CAP and NABL Accredited)
- Bio-statistics and report writing
- Pharmacy Services – ensuring strict adherence to GCP and other international regulatory requirements
- Translation of study documents
- Medical monitoring and safety monitoring
Lotus Labs Advantages
Dedicated Project Management Team
Lotus project managers have vast experience and expertise in providing effective leadership for global and local clinical studies
Lotus team has experience in monitoring and managing clinical studies in various parts of the world for different regulatory agencies
Skilled and Focused Site Management
Efficient monitoring of clinical study sites ensures stringent compliance to protocol, GCP and regulatory requirements. Monitors ensure and establish effective communication with the study staff to achieve high quality standards.