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Clinical Research Training
One of the world's leading human therapeutics companies in the biotechnology industry, this firm maintains a productive product pipeline that involves scores of clinical trials around the world each year.
Fulfilling its responsibilities as sponsor of those trials demands the compliance of its own organization and of responsible parties that can include Investigational Review Boards, Contract Research Organizations, Contract Research Associates, trial monitors, investigators and study site personnel.
UL assists the company comply with its responsibilities as the sponsor of clinical trials through a comprehensive knowledge solution, the foundation for which is Compliancewire®, UL's Part 11-validated system on the UL Platform, and our Critical Information Control System® (CICS).
Our clinical research training solution provides the following benefits:
- Enables the distribution, validation and documentation of critical information including Standard Operating Procedures (SOPs), study changes and status, regulatory updates, and corporate policies and procedures related to each clinical trial
- Provides a repository of resources for responsible parties ranging from Good Laboratory Practices (GLPs) to HHS-based requirements for patient confidentiality, ethics in clinical trials, and curricula for the certification of contract research associates.
- Delivers online testing for comprehension of critical information and curricula content, ensuring proficiency and understanding by responsible parties regardless of job function, language, knowledge level or changing regulatory requirements.
- Provides remote data entry to minimize the potential for errors in documentation and to comply with recordkeeping requirements.
- Stores all activities in audit-ready formats to protect the integrity of data and to comply with regulatory requirements.
UL's clinical research training solution enables the sponsor to manage the dissemination and integrity of information to and from its study partners around the globe.
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