Axiom Presents “Preventing Failure: How to leverage people and technology to mitigate common FDA audit findings” at Outsourcing in Clinical Trials Southeast 2021
DURHAM, N.C., March 29, 2021 (GLOBE NEWSWIRE) — Axiom Real-Time Metrics (“Axiom”), premier provider of unified eClinical solutions and services focused on small-to-medium life science organizations, is exhibiting on March 30-31, 2021, at the annual Outsourcing in Clinical Trials Southeast. The 2021 edition of the conference will be hosted virtually, welcoming pharma and biotech companies in the region to share knowledge and brainstorm solutions to challenges in clinical trial operations and technological solutions.
Sharing their expertise, Axiom’s Heather DiFruscia, Associate Director of RTSM/IWRS, and Brian Dempster, Senior Director of Global Clinical Management, will be presenting “Preventing Failure: How to leverage people and technology to mitigate common FDA audit findings,” on March 30th at 2:30 PM EDT/11:30 AM PDT. The session will highlight the advantages of eTMF documentation and key considerations, how to set and monitor your metrics accordingly, and the benefits of integrated systems.
“Failure to prepare is preparing to fail,” Dempster explains, “Documentation in clinical trials unfortunately often becomes an afterthought. At Axiom, we believe in starting with the end in mind, a clear plan at the outset of the study is very important, supported by an intuitive and smart solution for managing your TMF. Axiom’s Fusion eTMF module has a built in eTMF Health Reporting feature that monitors and sends smart notifications on overdue or missing documentation.”
“TMF preparedness is essential to passing FDA audits,” DiFruscia added. “Often times when you are working on a study, you might have data in separate systems. Without central access to key data, your study team may be delayed in documenting and addressing issues. Fusion’s eTMF module connects seamlessly with our other eClinical solutions such as EDC, RTSM, and ePRO so all of your study data and documentation is in one place.”
Learn more about Axiom’s Fusion eClinical Suite: https://www.axiommetrics.com/fusion-eclinical-suite/
About Axiom Real-Time Metrics
Headquartered in Toronto, Canada, Axiom delivers intuitive, powerful and cost-effective eClinical solutions and services focused around your entire study. Axiom Fusion eClinical Suite delivers a powerful range of innovative end-user focused, unified functionality and 15+ modules. Fusion serves as the Connected Hub for your entire clinical study data and operational needs. Fusion Delivers: EDC, DM, RTSM/IWRS, CTMS, Inventory Management, ePRO, IVR, Patient Portal, AE/SAE Tracking, Safety Database, Central Lab, Imaging, eTMF, and 24/7 Project and Clinical Data Reporting. Services include: Data Management, On-Demand Data Analytics, Biostatistics and Pharmacovigilance.
For more information, please visit https://www.axiommetrics.com