Compliance Implementation Services (CIS), a pharmaceutical compliance consulting firm, is pleased to announce that it is expanding its Clinical R&D Compliance services with additional tools for Good Clinical Practice (GCP) Benchmarking and Key Performance Indicator (KPI) development.
CIS applies metrics to GCP compliance areas, allowing clients to routinely monitor, evaluate, and remediate clinical compliance risks. CIS uses its proprietary Inspection Readiness Profiles and GCP Regulatory Requirements Inventory tools to internally benchmark the current state of a sponsor’s GCP Quality Assurance and Quality Control systems and supporting controlled documents. This internal benchmarking identifies GCP compliance risks, provides a data-driven list of areas for improvement, facilitates rapid process enhancements, and enables application of root cause analysis and Corrective and Preventative Action (CAPA) planning for more complex compliance issues. Internal benchmarking is an early and essential step in establishing GCP Key Performance Indicators (KPIs), leading to a new measure of sponsor control and oversight of GCP compliance.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.