SciMax and Oracle Collaborate to Expedite Reporting of Adverse Events, Aiding Operational Performance and Regulatory Compliance
SciMax Global, a leading scientific communications and medical affairs consulting and technology solutions provider, in collaboration with Oracle and Techsol Life Sciences, an Oracle PartnerNetwork (OPN) member, are now able to provide Life Sciences customers the ability to have timely compliance with reported Adverse Events (AEs) through an out-of-the-box integration that adheres to industry standards, defined by ICH E2B. Oracle Argus is an industry-leading solution for processing, analyzing, and reporting adverse event cases originating in pre- and post-market drugs, biologics, vaccines, devices, and combination products. Oracle has recently been named a Leader in the recent IDC MarketScape: Worldwide Life Science R&D Pharmacovigilance Solutions 2022 Vendor Assessment. The integration between SciMax’s fully validated SCIMAX MI (MedInquirer) system and Oracle Argus aids in critical responsiveness to AE reporting. “SciMax has long recognized the important role medical information plays in being on the front line of receiving potential Adverse Events. SCIMAX MI has comprehensive AE data capture capabilities as well as duplicate search, case versioning and follow-up processes which ensure the pharmacovigilance team has all the relevant and critical data in a timely manner,” Joe Pierce, CEO of SciMax said. The out-of-the-box integration allows for a seamless transfer of initial and follow-up AEs to Oracle Argus received with medical information requests or independently from SCIMAX MI while helping ensure correctness of data captured, completeness of data transferred, and adherence to time compliance requirements. “With our best-in-class cloud platform, SciMax is leveraging the scalability and technology integration capabilities that Oracle Argus provides to future-proof its services, and to provide Life Sciences customers with expedited reporting on Adverse Events,” said Drew Zwiebel, Global Vice President, Alliances & Channels, Oracle Health Sciences. The integration leverages industry standard E2B. SCIMAX MI supports the generation of an extended E2B for all data captured as part of an Adverse Event. The E2B can be transmitted via gateway to Oracle Argus as an initial or follow-up AE. Oracle Argus can import and send an acknowledgment back to SCIMAX MI with a Safety System ID and any additional data required by SCIMAX MI. The elimination of manual, double data entry protects against inaccurate data being entered into the AE system. The integration has been fully tested and validated and is available with minimal configuration. “As a preferred, leading digital transformation and system integration partner of both Oracle and SciMax, Techsol has been leading efforts in successfully implementing the integration between Oracle Argus and SCIMAX MI for more than three years now across multiple customers,” said Satya S S Sagi, Founder & CEO, Techsol. About SciMax SciMax Global is an innovative Scientific Communications and Medical Affairs consulting and technology solutions provider in the pharmaceutical industry. With a unified cloud Technology Platform and value-driven Consulting Services, SciMax has proven capabilities to help Pharmaceutical and Life Science organizations manage Medical Affairs programs. About Oracle Health Sciences As a leader in Life Sciences cloud technology, Oracle Health Sciences’ Clinical One and Safety One are trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance. With over 20 years’ experience, Oracle Health Sciences is committed to supporting clinical development, delivering innovation to accelerate advancements, and empowering the Life Sciences industry to improve patient outcomes. Oracle Health Sciences. For life. About Techsol Techsol Life Sciences is an integrated clinical development, medical affairs and post-marketing surveillance business solutions provider to global biopharmaceutical, medical device, food, and nutraceuticals companies. With our commitment to bringing novel treatments and therapies faster to market, we deliver regulatory compliant clinical research services, GxP technology consulting solutions in combination with our unified SaaS platforms. Using our deep-domain scientific expertise and technology innovation, we help sponsors to reduce time-to-market, save costs, and realize maximum value, across pharmaceutical and medical device business functions through clinical research, compliance oversight, insights generation, digitalization and GxP process automation. Trademarks Oracle, Java and MySQL are registered trademarks of Oracle Corporation.