Pharma

BCC provides expertise on all pharmacovigilance / safety related activities and documentation for pre and post marketed products and handling various safety issues during the life cycle of drugs. 

Independently analyze, evaluate and medically interpret aggregate adverse event data, taking into account underlying disease in assessing causality, managing risk and optimizing benefit/risk of products. BCC conveys innovative approaches to signal detection and data-mining.  BCC provides insight to achieving favorable product safety labeling, offering an external market perspective. BCC is recognized for sound medical judgment and novel alternative methods to problem-solving. BCC has a broad breadth of knowledge and experience in managing global pharmacovigilance activities across all stages of global drug development.

BCC`s expertise include  signal detection, evaluation and the management of automated systems, safety data/medical literature analysis; case processing, aggregate safety reports, case reports, medical assessments of adverse event reports, regulatory documents, single case review. The worldwide global industrial expertise also  include  safety monitoring of clinical trials, working with multidisciplinary  clinical trial teams, submission and registration for new indications, overview of clinical study protocols, medical writing, etc.