Clinical trials labeling control

PRISYM ClinTrial is a feature rich module that combines with other products to provide a safe, accurate and traceable labeling environment for clinical trials.

When used in conjunction with PRISYM Medica, the solution fully complies with the requirements of 21 CFR Part 11, GCP and GMP.

PRISYM ClinTrial can help in meeting GLP, GCP and ISO requirements for clinical sample/material/product labeling and record keeping.

Deliverables

• Clinical trials label printing
• Secure access, event and audit logging
• Patient stratification
• Removal of patients during the trial
• Multiple centre, visit, treatment logging
• Customization of user-define variable
• Randomization based on treatments and stratification
• User definable group-weighting and sizing when randomizing
• Import/export to legacy databases (ODBC, DSN, CSV)
• Full product life cycle documentation

Options

• Integrated labeling and management
• 21 CFR Part 11 compliant
• GAMP 4 based product life cycle documentation
• Biometric user recognition
• Customized validation of installed system
• Custom software development and integration
• Custom database design and integration
• Customized maintenance and servicing
• Customized support and training

Applications

• Clinical trials labeling
• Trial materials storage and transfer

See what our clients are saying about PRISYM Clintrial

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Other pages you may find useful:

Prisym Clintrial
Prisym Inventory Manager
Prisym Medica
Prisym Medica Web
Prisym V5