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Pacific Drug Safety Summit: Getting Data from EDC to Safety Systems

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SafetyFirstFor the third consecutive year, Medidata was a Silver Sponsor at the 7th Annual Pacific Drug Safety Summit (PDSS) in San Francisco. The first day of the conference (which is the most exciting to me) was broken up into half-day tutorials, where we were able to sit down with a group of industry leaders and discuss our particular topics. Medidata had the privilege of leading one of these tutorials, which was on ”Pharmacovigilance and Clinical Trials: Minimizing Costs, Increasing Compliance and Increasing Data Quality.” We invited Krishna Patel from the Prudentia Group, who has some real hands-on experience with electronic data capture (EDC) to safety solutions. We also invited Kyle Stretch from Extedo to help co-present our tutorial. We were able to speak with various sponsors, partners and consultants about their challenges in getting data to a safety system from their EDC system, including the data quality and reconciliation issues. We discussed how technologies are allowing data that is already being captured in EDC systems to be sent electronically to the safety systems. This helps improve the data quality, reduce query cycles and significantly reduce reconciliation, along with many other benefits. We looked at how solutions like Medidata Safety Gateway can help address those challenges. It was an interactive and productive session and everyone I talked to was very happy they attended. As companies start to look at more effective and efficient ways to run clinical trials, redundant tasks like the entry of patient and safety data and medical coding need to be consolidated. Central coding and electronic exchanging of data from EDC to safety systems were discussed in quite detail, and it will be exciting to see how companies in the life science industry work to improve these processes. We spent most of the second day watching presentations by various companies and industry experts. Jen Markey, director of life sciences R&D at Deloitte Consulting, discussed current trends in drug safety and medical communications. And presenters from Abbvie, PRA, Eli Lilly, Incyte and November Research enlightened us on ways they are addressing various safety-related topics, like outsource safety or the handling of investigational new drugs (INDs). To me, the most exciting presentation of the day was on how organizations are managing adverse events (AEs) in company-sponsored media and mobile initiatives. As our world and industry communicate and receive more and more information via social media and mobile devices, it was interesting to hear how companies are adapting to monitor and control AE data captured through those outlets. PDSS gave a better understanding of how important it is to be able to successfully transfer data from EDC to safety systems. That way, companies can spend more time on evaluating the AE and patient data so they can make the proper assessments and then report to the regulatory authorities, rather than spending a lot of time manually entering data or reconciling databases. Guest blogger Sean Neal is a client services principal and principal consultant at Medidata. You can reach Sean by email or follow him @SafetyGateway.

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