Narrowed profit margins, patent expiries on profitable drugs and escalating R&D costs have put significant pressure on Life Sciences organizations. The number of new product launches too have taken a hit. The estimated amount of introducing new drugs stands at $2.9 billion on average. There has been a serious amplification in market competition and surging customer expectations. Adding to the predicament, Life Sciences and Pharma companies must also adhere to stringent regulatory standards to improve the efficiency and quality of healthcare. Restoring consumer and investor confidence, and optimizing product portfolio to the patient population have been a top priority for Life Sciences and pharmaceutical firms.
The FDA (Food & Drug Administration) mandates healthcare professionals to provide detailed reports in case of Adverse Drug Reactions (ADR) when administered by a patient. Drug manufacturers need to be compliant with reporting regulations, and must compulsorily monitor the quality of drugs, and report any suspected undesirable effects encountered during the manufacturing process. Any delay in reporting will cause reporting to be inaccurate and unreliable. Drug Manufacturers and Pharma firms are compelled to build a robust reporting system for ADR assessment within their operations and get compliant of safety data.
Element has just the thing,
Great way to Save Costs – A Worry-free way to Ensure Compliance
Element’s collective response to the above underlying challenges is Corporate Adverse Event Reporting & Evaluation System (CARES). With CARES, organizations can benefit from a global validated mission-critical reporting system to perform accurate and timely reporting on adverse events related to manufacturer’s drugs at extremely reduced costs.
Successful deployment – It’s more than just numbers
Our extensive experience in the Life Sciences domain has translated to many successful deployments of our reporting system to leading Life Sciences organizations in more than 170 countries worldwide. We make use of the latest and trending technologies to effectively ensure quality and accuracy of the source data and timely reporting and ensure efficacy is maintained until the very end.