Risk-Based Monitoring (RBM) is changing the way companies are conducting clinical trials. Adopting RBM requires changes to a company’s processes and tools for monitoring. Building a quality risk management program and implementing technology will be critical in strategies to increase quality and efficiency and deliver accurate analyses of clinical study site performance and data quality.
In this session, you’ll have the opportunity to analyze your current approach, your biggest people challenges and leave the session with specific actions you can take (or strategies you can use) with the people on your clinical team.
Do you have a system in place to prevent noncompliance and to ensure effective action planning with follow-up in the event of a significant deviation? The ICH E6 GCP updates expects that you do!
Attend our webinar training on the essentials of CAPA and Root Cause Analysis to apply to your clinical trials!
Good Documentation Practices are essential to a clinical trial’s success. New ICH GCP E6 (R2) guidelines provide updates and clarity to GCP definitions for documentation. Join us for this interactive session to learn more.
With the recent ICH E6 changes to include Quality Management in the conduct of clinical trials, it is important for companies to understand how to implement Quality Management – which includes Risk-Based Monitoring (RBM) – into their studies. The purpose of this session is to help you develop and implement a change management strategy that eases the burden of transition.
Whether you are kicking off a new project, trying to regain control of ongoing study financials, or just trying to gain best practices, this session will help reduce unpredictable scope increases and “wow” change orders, keeping you on top of your budget through your trial.
Successful completion of these three training sessions is intended to meet the needs of individuals who are either new to biopharmaceutical-based document management, Information Management, and regulatory submission publishing for health authorities, or already experienced in one area and looking to gain a broader understanding of the full continuum of regulated document and submission production activities.
Even with increased efforts to harmonize regulatory requirements between the US and European Union, the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) have different requirements for initiating and conducting clinical trials for medicinal products. Deciding which standards to follow and how to harmonize/organize your own efforts is a daunting task.
While pharmaceutical and biotech companies outsource clinical trial tasks to CROs, Sponsors retain responsibility for the safety of subjects and regulatory requirement compliance and must ensure that the CRO is managing the trial correctly. Join our 90-minute interactive to identify the steps of conducting an effective audit to determine a CRO’s compliance to GCP requirements, study protocol and CRO/Sponsor Contractual Agreements.
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