PRISYM ClinTrial is an ‘add-on’ software module to PRISYM Medica labeling software that provides additional features for managing randomized medical studies labeling and records for Clinical Trials. It is ideal for securely and accurately managing data for clinical trials supplies and complete patient kits / patient packs labeling that is completed in most clinical research trials.
When used in conjunction with PRISYM Medica, PRISYM ClinTrial software supports you with complying to the requirements of FDA 21 CFR Part 11. This clincal trial labeling software is based on GAMP V model and so can support you in meeting GLP, GCP, GMP and ISO requirements for clinical research trials samples, clinical trial phases and clinical trials drug labeling, drug packaging, and record keeping.
PRISYM ClinTrial software enables you to deliver:
- Clinical trials phase label printing
- Secure access, event and audit logging
- Patient stratification
- Removal of patients during the trial
- Multiple center, visit, treatment logging
- Customization of user-defined 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 lifecycle documentation
PRISYM ClinTrials software offers:
- Integrated labeling and management solution based on current labeling regulations
- Support in acheiving 21 CFR Part 11 FDA compliance
- GAMP 5 based product lifecycle 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 for PRISYM ClinTrial software
- Clinical trials labeling following labeling regulations
- Randomized study labeling
- Patient pack labeling
- Treatment kits labeling (drug labeling)
- Clinical trials supplies labeling (drug packaging)
- Pharmaceutical valuation
- Medical clinical trials
To find out more about PRISYM ClinTrials visit www.prisymid.com
