Life Sciences is a highly regulated industry, and companies in this industry have a particularly important responsibility of complying with various rules and regulations across all functions of the business. The amount of new rules and regulations is continuing to increase, and the complexity of compliance is greater than ever before. Responding to this growth and complexity is a major challenge and the risk of non-compliance is high and can result in big fines, a damaged corporate reputation and most notably presents serious danger to patients’ lives.
Mar 19, 2019

In order to keep up with the changing pace, the approach to compliance needs to change. Many companies treat each compliance requirement as a separate management program, whether it’s clinical trial reporting, manufacturing lot tracking, pharmacovigilance, or any other requirements from a wide range of possibilities, and these programs tend to multiply. To add to this, each program often develops its own method for gathering data and reporting to regulatory authorities. This increases the cost of compliance as well as the potential for oversights and mistakes. A better approach is to standardize compliance, get closer to business partners, and build compliance into their business process. This is where an analytics solution can help.

With an analytics solution, and by harnessing all of the data that you and your business partners have access to, you can implement an integrated enterprise compliance architecture for collecting, organizing, and analyzing large volumes of compliance data and identify key actions for internal attention or provide reporting to the appropriate regulatory authorities in a uniformed manner. You’ll be able to:

• Optimize regulatory supervision for a streamlined product approval process
• Improve your pharmacovigilance with enhanced data analysis
• Intuitively analyze adverse reactions
• Monitor critical KPIs such as serious flags, proportional reporting ratios, and timeline for report to FDA (including the number of late reports and reasons why)
• Leverage AI to run algorithms to make ongoing improvements to your efforts and to predict the next breach or issue
• Track and evaluate your standing across multiple compliance programs to avoid errors and improve overall compliance effectiveness
• Streamline legal reporting and project management
• Benchmark safety measures

The consequences of non-compliance are serious, and there is no room for oversight and mistakes. At SDG Group, we specialize in helping Life Sciences companies to access and analyze all of their data, and we implement solutions that help standardize and improve regulatory compliance. Please contact us to learn more about how we are helping our customers in the Life Sciences industry.