CIS Implements Tools to Benchmark and Develop KPIs for Good Clinical Practice Adherence
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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
