Clinical Pharmacology and Medical Affairs (CPMA)
bullet Clinical Pharmacology and Medical Affairs (CPMA):
With an extensive understanding of the intricate global generic business, we, at Lambda, have established a niche group expertise to handle Bioavailability and Bioequivalence studies for global regulatory submissions. This group also conducts Phase I (First in man) studies. The group consists of Medical professionals, Pharmacologists, Pharmacists, Nurses, Phlebotomists and others who are involved in:
 
bullet Seeking regulatory/IEC approvals
bullet Subject recruitment
bullet Subject screening and enrollment
bullet Design of protocols, informed consents and case record forms
bullet Conduct of clinical studies
bullet Ensure safety measures to enrolled subjects
bullet Writing integrated reports
 

We have access to 260 beds at Ahmedabad, 40 beds at Mumbai and 110 beds at Chennai facilities and have the capacity to undertake 15 - 18 Bioequivalence studies per month, depending on the size of the study. Currently, we enroll almost 800 - 900 subjects per month which entails screening of almost 1900 – 2100 subjects in a month. We have the capabilities for undertaking studies ranging from simple to complex designs such as: two-way, three-way, four way, five-way crossover, replicate designs, food effect studies, multiple dose studies, special population studies on volunteers including : Female Volunteers / Post Menopausal Volunteers / Geriatic Population studies, BE studies on patients etc.

Supported by a well equipped Clincal Lab and a Bioanlytical lab, we, at Lambda, can qualify as the right partner towards your drug development programme.

Our rugged procedures have been challenged and scrutinized by sponsors and regulatory agencies like ANVISA (Brazil), WHO, AFSSAPS (France), USFDA. Our commitment towards “Quality” and the regulatory audits have made Lambda one of the most successful clinical research partners in the region.

We have conducted more than 875 BA/BE studies, out of which 257 pilot studies and 618 pivotal studies. We have made 290 submissions to the European Union, 255 submissions to the USFDA, 17 submissions to ANVISA (Brazil), 28 to Canada, 16 to Australia and 12 to ANZ. We have successfully completed 12 Phase I studies (single ascending doses in oral and intravenous doses). Majority of our projects emerge from our existing clients, which strongly suggests the importance that Lambda gives to communication, project commitment and trust. It is the power of relationship and we value it.