Having around 700 qualified investigators from different specialties and access to varied patient population, Lotus Lab clinical development team has recently completed two patient based studies – one CNS bioequivalence study and one acne end point study in dermatology. The team is currently working on two oncology patient based studies and two ophthalmology (glaucoma and cataract related) studies. By the end of the year, the company proposes to initiate at least two more studies in urology and dermatology.
Established in 2001, Bengaluru based India’s leading full service CRO Lotus Labs has recently set up a full-fledged data management team to handle all the ongoing studies. The company has also tied up with channel partners for IWRS and packaging/ labeling requirements for the studies. Lotus has worked with sites in India, Bangladesh, US and also works with channel partners in Europe, US and ROW to cater to the global multicenter studies.
Inspected by US FDA, EMEA, ANSM, AGES, WHO, ANVISA, MHRA, MCC (South Africa & Zimbabwe), SFDA (Saudi), NPCB (Malaysia) and MOH Turkey, Lotus has successfully completed 65 Regulatory Inspections and is also approved for submission of studies to countries like GCC, Israel, Sudan and Tanzania. More than 180 BA/ BE studies conducted at Lotus have been approved by US FDA with no observations since last four audits.
Lotus has conducted clinical trials (phase II to IV) ranging from single to multi centre sites, with patient population enrolled in these studies ranging from 20 to 1200 in number and from various therapeutic segments like cardiovascular, psychiatry, oncology, neurology, diabetes, endocrinology, dermatology and nutrition.
The company has done clinical trials for various regulatory submissions; sites involved in two of our clinical trials have been successfully audited by US FDA.
Lotus has a fully equipped state-of-the-art 12 beds, phase I unit managed by a team of well trained and experienced professional staff. It offers specialized early phase services for First-in-Man 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 offers specialized services in the areas of bioavailability and bioequivalence, phase-I, clinical trial management phase II –IV, central laboratory, regulatory and data management backed by strong scientific and technical support.
The services are offered either as a package or as standalone services depending upon the client requirements. BAand BE:
Lotus Labs has a capacity of 340 beds (4 clinical facilities) and conducts around 14 clinical studies every month for various regulatory submissions, utilizing a database of 17000 healthy volunteers (male and female). Located in Bengaluru and Chennai, it has completed more than 1800 studies for all kinds of formulations including orals, injectables (IV, IM and subcutaneous), respiratory inhalers, extended release formulations, trans dermal patches, nasal and oral sprays and for topical preparations like creams and ointments and vaso-constriction studies.
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 from AB Sciex including 6 API 4000 and API 5500), 2 from Waters (Xevo TQ-S) and 4 HPLC. Lotus has developed around 380 validated methods and has bio-analytical capacity to analyze 35,000 samples every month. There is a dedicated team for developing and validating methods to take up MDMV according to study requirements.
Central laboratory services
Central laboratory at Lotus is College of American Pathologists (CAP) and NABL certified in accordance with the international standards of ISO 15189. Located in Lotus House, the lab is spread over 1400 square feet and the infrastructure includes state of the art equipment and experienced staff. The lab is also equipped with laboratory information system (LIS) to ensure the security and integrity for the online data transfer. All the samples generated from the in house BA/BE studies and clinical trials are analyzed at this lab. The lab services as a reference laboratory to other CRO’s also.
Recognitions
The company has 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. At the recently held 6th International Achievers Summit at Bangkok, Thailand, Lotus Labs was the recipient of “Fastest Growing Indian Company Excellence Award 2014” in the Global Corporate Achievements and Social Responsibilities segment.