Lambda Mumbai Operations also go paperless with EDC implementation

After implementation of EDC at Ahmedabad, Lambda extended its EDC capabilities to Mumbai making itself a Paperless Green Clinical Research Organization. This has been achieved by implementing a robust 21CFR Part11 compliant electronic data capture (EDC) system having added layer of security and controls with logical edit checks assuring faster and cost effective clinical trial solutions.

Successful conduct of another Nutraceutical study

Lambda successfully conducted another Nutraceutical study for an MNC after adding a new dimension to its capabilities by completing first nutraceutical study in recent past. Lambda has bestowed a new track record in the area of Nutraceutical studies with its customized cost-effective solutions. The companies intending to conduct studies in a standardized, scientific & competitive manner can rest assured to meet their expectations when study is awarded to Lambda to be conducted at Lambda’s state-of-the-art units.

Lambda successfully completes Pharmacokinetic analysis of Biosimilars

Lambda has successfully completed Pharmacokinetic Analysis of Biosimilars including EPO, Peg-GCSF and Peg INF a 2b for multicenter clinical trials. Lambda’s best-in-class CAP & NABL accredited Central Clinical Lab, is well equipped with latest techniques to perform various investigations and analysis.

Lambda has successfully validated Method for Orlistat (Food Fat and Fecal Fat Estimation) on FT-IR

Lambda has successfully completed Method Validation for Orlistat (Food Fat and Fecal Fat Estimation) on FT-IR instrument thus adding another "challenging" method in the list of its 600 validated bioanalytical methods.

Lambda has Successfully faced MHRA inspection of Bioanalytical lab at London

Lambda facilities have been inspected several times by various regulatory agencies successfully in past. Recently, Lambda’s Bioanalytical Lab at London has also been inspected by MHRA regulatory agency without any issues raised by authority.

Lambda successfully completes a high profile Phase I trial for a New Chemical Entity

Lambda successfully completed a Phase I trial for an NCE for Obesity. In total 28 patients were randomized, dosed & housed for the trial. The trial was completed within the prescribed time at our state-of-the-art Phase I unit at Lambda, Ahmedabad. Lambda with its special population databases like Diabetic & Obese patients is in the best position for efficient, timely & highly competitive execution of Phase I studies.

Lambda successfully conducts Nutraceutical study for a MNC

Adding a new dimension to its capabilities, Lambda successfully conducted a Nutraceutical study for an MNC. Thus, Lambda has once again raised the bar for Quality-conscious Nutraceutical companies intending to conduct studies in a standardized, scientific & competitive manner at its state-of-the-art units.

Lambda successfully faces ANVISA inspection in August 2011

After successfully facing a combined MHRA & AFSSAPS inspection in May 2011 becoming the first CRO in India to get accreditation by Ministry of Turkey as a recognized center to conduct Bioequivalence studies for Turkey submissions, Lambda successfully completed ANVISA inspection in August 2011 without any major findings.

Lambda's Ahmedabad facility approved by Ministry of Health, Turkey

Lambda's Bioavailability and Bioequivalence (BA/BE) facility at Ahmedabad, has been conferred by the GENERAL DIRECTORATE OF PHARMACEUTICALS AND PHARMACY FOR BA/BE STUDIES from the MINISTRY OF HEALTH OF TURKEY for the execution of studies in the centre. This award has been granted after the Ministry's delegation conducted a thorough inspection of the Systems and Processes of this facility to ensure that they are compliant with "last text of Helsinki Declaration", "Good Clinical Practices" and other related regulations.

Lambda becomes the first Indian CRO to offer Medical Imaging & Central Review services

Medical Imaging based surrogate end-points have become essential for clinical trials to provide an insight to drug safety and efficacy much faster than traditional clinical endpoints. Lambda is well placed to offer full spectrum of Central Review Services for wide range of therapeutic segments (including Oncology, Musculoskeletal, CNS) fully compliant to regulatory requirements.

Lambda offers UK based end-to-end PV services

Lambda's Pharamcovigilance unit offers - EU Qualified Person Services, Adverse event processing in an indigenously developed Validated Safety Database approved by the UK-MHRA, Risk Management Statements, Literature search and PSUR generation.

Lambda Therapeutic Research acquires North American CRO

Lambda Therapeutic Research, a multi-national Contract Research Organisation (CRO) headquartered in Ahmedabad, India successfully acquired from Biovail Corporation the business and assets of its contract research division, Biovail Contract Research (the “Biovail CRD Business”), through its subsidiary Lambda Therapeutic Research Inc. (“Lambda Canada”).

Mrs. Bindi Chudgar, Managing Director-Lambda said the company will now have a global infrastructure of 600+ clinical beds dedicated to Phase I Clinical Pharmacology, and ANDA/505b2 bioequivalence trials along with 45+ LC-MS/MS instruments and the full spectrum of clinical data management and biostatistical services.

Lambda is projecting strong growth at its four principal locations and as a result of this acquisition, the 2011 gross revenues of Lambda is projected in excess of $50 million USD. With a strong worldwide infrastructure in India, the United Kingdom, Poland and North America Lambda is uniquely poised to outperform the industry in 2011.

Lambda Canada will operate two facilities with over 46,000 square feet dedicated to clinical/bioanalytical services in Toronto, Canada. These facilities house six study clinics (including a 12-bed, Phase I First-in-Human unit) and a total capacity of 194 beds, as well as a clinical contact centre and subject screening unit, a fully equipped bioanalytical laboratory and a full-service clinical data management department.

Lambda Canada is led by a seasoned Management and Scientific Leadership team supported by a staff complement of 100+ employees experienced across all therapeutic disciplines. The Canadian business has conducted over 3,500 Phase I, bioavailability/bioequivalence and/or drug-interaction studies on more than 400 different chemical entities. They have a database that exceeds 100,000 adult male and female volunteers for potential enrollment in studies.

Additionally, with this acquisition Lambda has the enviable track-record of having been audited with systems and procedures in full compliance with the regulations of the United States Food and Drug Administration (US FDA), Therapeutic Products Directorate (Health Canada), European Agency for the Evaluation of Medicinal Products (EMA), and other comparable foreign regulatory bodies.

Mrs. Chudgar also added that this acquisition was seamlessly completed owing to their prior experience of having similar acquisitions in the UK, Europe and the USA. A major driver for this deal was the constant demand and requests from Indian clientele for cost effective solutions with international expertise. This Canadian acquisition allows Lambda to take advantage of the expedited Canadian regulatory filing process, which will be well within the reach of Lambda's clients across the world. Processes for seamless integration and all possible synergies have already been identified and poised to benefit Lambda's clients worldwide.