Business & Decision Life Sciences provides expert consulting services to identify and fulfill signal detection requirements in the pharmaceutical and medical device industries as well as other sectors.
Signal detection is more than simple data analysis associated with adverse events. Regulatory Expectations are that Life Sciences companies should be able to detect safety signals by proactively analyzing multiple sources of data from across different business domains (product development, clinical trials, post-marketing surveillance, customer complaints, etc). However, the need and ability to detect such signals varies between different Life Sciences organizations and it is important that processes and tools are relevant to the risks associated with the products, processes, and data being analyzed.
Business & Decision Life Sciences' experience in this field allows our consultants to fully analyze specific requirements for signal detection and design appropriate, proactive processes for signal detection and the reporting of safety data. To meet the requirements of each client, our consultants establish project needs, assess tools, technologies and vendors, and select the right solutions to allow alignment with regulatory expectations.