Clinical
& Regulatory AffairsThe Clinical and Regulatory Affairs (CRA)
of Biological E. Limited was
established in 2002 with a vision to create
a force in the clinical research arena in
full compliance with ICH - Good Clinical Practice
(GCP) guidelines.
Its mission is to engage in challenging Phase-II
to Phase-IV clinical research programmes for
a growing portfolio of domestic and internationally
based pharmaceutical clients.
The CRA team consists of young, dynamic, passionate
and enthusiastic research professionals. They are capable of meeting
and delivering robust results to all study
requirements
through experience and commitment.
CRA respects and values the
relationship it shares with associated
organizations, right from understanding
the study requirements to designing the study
and tracking it to completion.
CRA is Committed· To completing projects successfully
· To meeting project timelines.
· To providing accurate results
· To accelerate decision-making
· To focus attention at every stage
of work
· To efficient and cost-effective systems
and services.
AchievementIn the short span of three and a half years
the CRA team has successfully conducted 4
single and multi-centric Phase III and IV
trials on a total population of 602 healthy
volunteers. CRA is currently working on two more studies in the area of preventive vaccines
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