Our experienced staff recognizes that a well designed and executed preclinical safety program is critical to a successful drug development strategy and we work with clients to provide customized programs to support their goals. Members of our team have personal, hands-on experience in the development, approval, and execution of safety programs including managing large safety assessment operations at major pharma companies. Our services include:
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Plan Design
Assisting in the design of the preclinical compound development plan
Auditing Support
Auditing support including qualification visits, in process, and/or post study audits
Quality Assurance
Ensuring that program studies are completed according to US FDA GLP guidelines and to the client’s quality expectations
Study Monitoring
Serving as a study monitor to ensure maximal CRO compliance and execution efforts, we audit/monitor most studies weekly or bi-weekly
Project Management
Keeping the program on track and coordinating the components of the various entities responsible for completion
Meeting Coordination
Arranging and leading project team teleconferences with client and scientific staff, providing English translation
Support Contact
Real-time support to help resolve any issues that may arise during the program’s conduct
Final Review
Reviewing/editing the final reports to meet Western standards of content and language
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