Lotus Labs, India’s leading full service clinical research organization based in Bengaluru caters to a host of generic pharmaceutical and innovator companies based in the US. Lotus has done clinical trials for FDA submissions and sites involved in two clinical trials have been successfully inspected by USFDA without any major observations.
Established in 2001, Lotus Labs prides itself as one of the most admired and first Indian CRO to receive the prestigious “International Star for Leadership in Quality Award” in 2011 at Paris, for its quality standards.
Lotus has also been recognized as one of the best enterprises in the field of clinical research from India by the European Business Assembly, Socrates Committee, Oxford, UK, 2012
Since its inception, Lotus Labs has grown rapidly to be one of India’s premier clinical research organizations. It is the preferred clinical and pharmaceutical research partner for several leading pharmaceutical and biotechnology companies across the globe offering specialized services in the areas of bioavailability & bioequivalence, Phase-I, Clinical Trial Management Phase II –IV, central laboratory, regulatory and data management backed by strong scientific and technical support. These services are offered as a package or as standalone services depending upon client requirements.
Regulatory approvals for bioavailability &bioequivalence
Lotus has been inspected by USFDA and other agencies like EMEA, ANSM, AGES, WHO, ANVISA, MHRA, MCC (South Africa & Zimbabwe) and MOH Turkey.
Lotus has successfully completed 60 regulatory inspections out of which 14 inspections have been by FDA with no observations since last four audits. Lotus is also approved for submission of studies to Israel, Malaysia, Sudan and Tanzania.
More than 170 BA/ BE studies conducted at Lotus Labs have been approved by USFDA
Clinical expertise & facility
Lotus Labs has a fully equipped state-of-the-art 12 beds, Phase I unit managed by a team of well trained and experienced professional staff who offer specialized early phase studies, clinical pharmacology / end point studies, exploratory studies for various biomarkers and special population studies in breast cancer patients, renal impaired patients and hypogonadal patients.
Lotus has conducted clinical trials (Phase II to IV) ranging from single to multicentre sites, with patient population enrolled in these studies ranging from 15 to 1500 in number and from various therapeutic segments like dermatology, cardiovascular, psychiatry, oncology, neurology, diabetes, endocrinology and nutrition for clients based out of US.
For fast patient recruitment for clinical trials, Lotus derives its strength from its database of around 700 experienced and highly qualified investigators from different specialties who are located across India having access to varied patient population. Lotus has worked on sites in India, Bangladesh and has channel partners in Europe, US & ROW to cater to the global multicenter studies.
Bioavailability & bioequivalence
Lotus Labs has a capacity of 340 beds (four clinical facilities, located in Bengaluru and Chennai) and conducts studies utilizing a database of 17000 healthy volunteers (male and female). Lotus has completed around 1650 studies for all kinds of formulations including orals, injectables (IV, IM and subcutaneous), inhalers, extended release formulations, nasal and oral sprays and topical preparations like creams and ointments.
Lotus Labs has experience of conducting BA/BE studies in most of the therapeutic segments including cardiology, CNS acting drugs, anti retroviral, diabetes, dermatology, oncology, gastroenterology, antibiotics among others, including studies in patient population.
Bioanalytical laboratory
Equipped with 15 LCMS-MS instruments - (13 AB Sciex including 5 API 4000 and API 5500), 2 Waters (Xevo TQ-S) and 4 HPLC, Lotus has developed around 300 validated methods and has bio-analytical capacity to analyze 30,000 samples every month. Lotus has a dedicated team for developing and validating methods and a processing area dedicated to working on light sensitive molecules.
Central laboratory services
Central Laboratory at Lotus is CAP (College of American Pathologists) and NABL (National Accreditation Board for Testing and Calibration Laboratories) certified in accordance with the international standards of ISO 15189 with infrastructure that includes state of the art equipment and experienced staff. The lab is equipped with Laboratory Information System (LIS) to ensure the security and integrity for the online data transfer. The lab services as a reference laboratory and is utilized by other CRO’s and global clinical trials.u
For more information visit:
www.lotuslabs.com