Compliance

WHITE PAPERS AND CASE STUDIES

• Comparative Analysis For Non-IND Sites

  A cancer research organization that facilitates multi-national clinical trials was in the planning and coordination of a Phase III drug trial and wanted to expand the trial to include German sites. Conducted under an IND, the trial was going according to plan until German regulations changed.

   

   

• Demanding More From AI Governance In Drug Safety

  Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.

• Preparing For Post-Market Clinical Follow-Up Under EU MDR

  Gain a better understanding of the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.

• eCOA Supports Successful Antianginal Trial

  Gilead Sciences’ previous studies of Ranexa (ranolazine) relied on data from exercise treadmill parameters as the primary endpoint. But collecting data in this manner is costly, logistically challenging, and bears questionable clinical relevance — especially at the individual patient level. Learn how Gilead Sciences successfully utilized ERT handhelds to collect regulatory-compliant, patient-driven data in support of the primary efficacy endpoint in a Phase IV study of Ranexa.

• Fire And Life Safety And Security Industry

  New government regulations and the need to update outdated or non-compliant technology are requiring building owners and facilities managers to think about upgrading their fire alarm, security, and fire suppression systems with the latest technology available.

• Workforce Management Solution Supports Smart Meter Rollout During the technology evaluation stage, CHED Services recognized an opportunity to derive further benefits from the launch of a proven enterprise workforce management system. By Ventyx
• Validation Provider Shortens The Path To Equipment Qualification

  Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

• Virtual Study Yields High Compliance & Retention Rates

  Clinical research studies involving repeated patient reported outcome measures (PROs) face several challenges. Patients may fail to complete individual PROs, whether at all or within a specified time (i.e., reduced compliance). Patients may cease participating in a study altogether, dropping out before all study procedures are completed (i.e., reduced retention). Read how an app was used in a study that enrolled 124 patients resulted in the majority of participants in the study being 100% compliant and retained through study end.

• How Social Technologies Are Creating A New Paradigm For Addressing Business Objectives

  This case study investigates how Within3 supported a culture of innovation by introducing three pharmaceutical companies to secure, regulatory-compliant virtual advisory boards. By Within3

• Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records

  Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

• Petzl America Ascends To The Next Level Of Distribution Petzl America, a leading distributor of climbing, mountaineering and safety equipment, needed to streamline distribution operations in order to continue to meet customer compliance requirements and changes in order fulfillment characteristics. Submitted by Cornerstone Solutions
• AIIM Eyes Records Management In Government And Beyond At a recent advisory board meeting for ECM (enterprise content management) trade association AIIM, the hot, compliance-driven topic was electronic records management. Written by Tom von Gunden, Chief Editor