Phase I Clinical Trial

Our leadership and a proven track record in the effective conduct of Phase I Clinical Trial – specifically Clinical Studies for Phase I-IV trials is reflected in the fact that Lotus Labs has strategic working relationships with reputed hospitals that ensures having access to a large database spanning diverse therapeutic areas. Lotus Labs has extensive capabilities to conduct Phase I Studies in healthy volunteers which include studies First-in-Man, Single ascending dose, multiple ascending dose and new chemical entities.This ensures that we always have access to a large database spanning diverse therapeutic areas to effectively conduct Clinical Trials that would eventually further the prospects of path breaking proprietary diagnostics and therapies.

Lotus Labs has independent Phase I clinical trial facilities, state-of-the-art instrumentation and the expertise to conduct First-In-Human Studies, Pharmacokinetics in healthy volunteers, Bio-availability & Bio-equivalence studies, Drug Metabolism studies, Dose Proportionality studies, Multiple dose studies and Clinical Development programs. Lotus Labs has considerable experience in various dosage forms including injectables, oral dosage forms including suspensions, topical preparations and delayed release formulations.

Phase I Clinical trial facilities at Lotus Labs are spread across 4 locations aggregating a capacity of over 360 beds, with separate areas for subject screening and blood draws, pharmacy, state-of-the-art fully equipped ICU’s and tie-up with a multi-specialty hospital in the vicinity to handle emergencies. What’s more for conducting Phase I Clinical Trial, Lotus Labs has access to a database of over 18,000 active volunteers.

At Lotus Labs, our research programs employ the latest study designs in clinical pharmacology, bioanalytical method development and Pharmacokinetic analysis, conducted by a team of experienced and well-trained clinical coordinators and research associates. Our 360° approach to Clinical Trials ensures that sponsors benefit from the entire gamut of services – Feasibility Studies, Volunteer Recruitment & Planning, Clinical Trial Supplies & Management, Project Management, Clinical Monitoring, Bio Statistics and Pharmacy Services – ensuring strict adherence to GCP and other international regulatory requirements.