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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:
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Seeking
regulatory/IEC approvals |
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Subject recruitment |
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Subject screening and enrollment |
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Design of protocols, informed consents and case record forms |
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Conduct of clinical studies |
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Ensure safety measures to enrolled subjects |
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Writing integrated
reports |
We
have access to 260 beds at Ahmedabad,
Mumbai and 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, 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 over 652 Bioequivalence
studies, over 389 of these being pivotal.
The majority of our submissions have been
to the Europe (185), USFDA (177), ANVISA
(17), Canada (11), ANZ (5) and Australia
(3). We have successfully completed 9
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.
Our expertise in first in man studies:
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Successfully conducted 9 phase 1 studies so
far
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Ability to recruit large number of healthy volunteers and conduct clinical studies at Ahmedabad and
Mumbai
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Evaluating pre-clinical data and preparation of
protocols
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Assessing safety
data
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Regulatory specific report
writing |
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