Business & Decision provides comprehensive and flexible pharmacovigilance and drug/device services and solutions that are broad in scope, delivering the highest level of regulatory compliance for its clients.
Regulatory agencies expect Life Sciences companies to take a comprehensive and proactive approach to assuring the safety of patients.
In order to fulfill such expectations Life Sciences companies must align organizational processes with regulatory requirements, incentivize the detection and escalation of risks, open and leverage new channels of collaboration, remove traditional barriers between the safety and clinical trials 'silos', and ensure 'C' level ownership of safety issues throughout the organization.
To meet increasing demands for the proactive management of safety issues, intelligent signal detection and analysis must be used for safety events and signals, leveraging new data management and data mining standards. This requires the use of technology which aligns operational and governance processes, standardizes terminology and data models, integrates data from multiple traditional and non-traditional sources and which provides incremental return on investment.
As recognized thought leaders in Life Sciences with significant experience in multiple business domains (drug/device development, clinical, operations, sales & marketing and regulatory compliance), Business & Decision is the ideal choice to assist organizations to meet the growing expectations for pharmacovigilance and drug/device safety.
Business & Decision's broad experience allows them to supplement traditional approaches to product safety (adverse events reporting and signal detection) with a broader, more strategic approach, integrating data and intelligence from the entire product lifecycle.
As an international consultancy and systems integrator specializing in Life Sciences we are able to assist clients in the assessment of their existing processes and systems, to develop Risk Evaluation & Mitigation Strategies (REMS), to advise on the selection of safety tools and systems and to implement and integrate solutions delivering a total safety solution.