Lotus Labs - Clinical Research Organisation, Clinical Trials, Clinical studies including BA/BE, PK/PD, Phase trials, SDS, MDS, Patient Studies, Bioanalytical Services, Solid Oral Formulations, Central Lab Services.

Lotus Labs is a Clinical Research Organization with extensive experience in conducting Clinical Trials and rendering services globally. With the nerve centre at Bangalore, India, Lotus Labs offers an extensive portfolio of services – spanning Phase I to III studies – for global pharmaceutical and biotechnology companies. With a battery of services, from end-to-end Clinical Trials to stand alone services, Lotus Labs has an impressive track record with expertise across all facets of Clinical Research.

Clinical Research Organisation India

As the preferred hub of Clinical Research Organisation - India & International sponsors, Lotus Labs is system driven, focusing on Client requirements including timelines with emphasis on quality. Clinical Research at Lotus Labs is powered by experienced professionals and cutting edge technology to adhere to globally recognized guidelines. Lotus Labs has extensive experience in conducting Clinical Trials in healthy volunteers, patients and special populations.

Clinical Research at Lotus Labs is powered by proficiency in the areas of Bio Studies, Clinical Trials, Bioanalytical Research, Biometrics, Medical Writing and Regulatory Services.

Clinical Studies BA/BE, PK/PD, Phase Trials, SDS, MDS

BA/BE studies

BA/BE Studies is one of the key services that are offered at Lotus Labs. The various studies on bioavailability (BA), bioequivalence (BE) and pharmacokinetics are conducted at our centers in strict compliance with international regulatory requirements. The BA/BE studies are meticulously monitored by an independent quality assurance department. Our expertise in BA/BE studies has ensured the development of over 240 validated bio-analytical methods to analyze over 30,000 samples per month. Lotus Labs has constituted a dedicated team which is competent to develop and validate a minimum of 5 methods for BA/BE studies every month.

PK/PD and Patient Studies

Lotus Labs offers best-in-class services to conduct Patient Studies and Special Population Studies through Pharmacokinetic and Pharmacodynamic studies (PK/PD studies) to assist its clients in drug development programs. Enriched by extensive experience and ably supported by cutting edge technology, teams at Lotus Labs have conducted several PK/PD and Patient studies. As part of the Patient Studies portfolio, our services include studies in Breast Cancer, Renal Impaired and Hypogonadal patients.

Bioanalytical Services

Bioanalytical Services has been a core competency at Lotus Labs to cater to the analytical testing requirements of Pharma and Biotechnology clients. Lotus Labs offers comprehensive bioanalytical services including method development and validation from several human matrices like blood, serum, plasma and urine, besides capability to analyze complex molecules for Phase I plasma samples from Oncology projects.

Solid Oral Formulation

A Solid Oral Formulation is a type of formulation used to analyse the absorption, distribution and elimination of various drugs. Solid Oral Formulations are actually tablets, capsules, soft gels and sprinkles. At Lotus labs, the experience in BA/BE studies addresses various formulations including Solid oral formulation (IR, ER, MR and dispersible tablets) and liquid oral formulations like syrups and suspensions. Lotus Labs, also, has considerable experience in various dosage forms including injectables like IM/IV and Sub Cutaneous (SC), topical preparation and nasal sprays.

Central Lab Services

Central Lab Services of Lotus Labs which are certified by CAP and NABL forms the core of various studies and research activities. The Central Laboratory is equipped with state-of-the-art infrastructure, an array of advanced equipment and impeccable logistics. The Central Lab Services provide Quick turn-around time with exemplary levels of consistency and quality. Central Lab Services are ably assisted by cutting edge technology including the latest in Laboratory Information Management System (LIMS) for online data transfer.