Clinical Trial Services
Unlike other GXP disciplines, GCP clinical research is performed at many different institutions and frequently on a global basis. Each investigator site is different and has its unique set of problems, yet the data from this research must be comparable and gathered in a consistent way that meets the letter and spirit of GCP regulations and guidelines to be viable in regulatory submissions.
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Examples |
Interphase Systems can help you:
- Address and correct issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the FDA,
- Training Clinical Trial monitors,
- Documentation development and,
- Audits
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- GCP Training of Clinical Monitors, Medical Monitors and investigational site teams
- Standard Operating Procedure development
- Development of Clinical Trials Documentation
- See Audits for additional Clinical Trial support
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