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UL’s technologies and curricula help ensure compliance demands are met before and after pharmaceutical, biologics or biotechnology products reach the market. UL’s subject matter expertise in the field of GCP training has helped organizations minimize risk, assure data integrity, and meet regulatory compliance.
Combine Technology with GCP Expertise
Our best-in-class LMS and comprehensive GCP courses offer learning in a fast, convenient and effective manner via the web.
In pre- and post-market studies, our solutions have enabled compliance training, communications and defensible recordkeeping that minimizes the potential for error, protects study-related compliance data and achieves cost-efficiencies in the management of dispersed study sites. UL has helped clients address:
- Training related to Good Clinical Practices (GCP), Electronics Data Capture (EDC), ethics and safety to comply with FDA, ICH and other regulations laws;
- Protection of patient safety, confidentiality and informed consent;
- Extension of training from sponsors to investigators and study personnel, Contract Research Organizations (CROs), Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs), Investigational Review Boards (IRBs) and regulators;
- Distribution, validation and documentation of all study-related communications including safety notices, regulatory updates and protocol amendments.
Global Regulatory Compliance Learning
Addressing International Regulatory and Corporate Compliance Requirements