Clinical Trials Software Labeling

PRISYM ClinTrial short for Clinical Trial is an "add-on" software module to PRISYM Medica labeling software that provides additional features for managing randomized study labeling and records. PRISYM ClinTrial is ideal for securely and accurately managing clinical trials data for clinical trials supplies and complete patient kits / patient packs labeling done in most clinical research trials

When used in conjunction with PRISYM Medica, PRISYM Clinical Trial software fully complies with the requirements of 21 CFR Part 11, GCP and GMP, and is FDA compliant for an FDA audit that checks for labeling regulations or pharmaceutical validation.

PRISYM ClinTrial can help in meeting GLP, GCP and ISO requirements for clinical research trials samples, clinical trial phases and clinical trials drug labeling, drug packaging, and record keeping.

PRISYM clinical trials software deliverables

• 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 life cycle documentation

PRISYM clinical trials software options

• Integrated labeling and management based on labeling regulations
• 21 CFR Part 11 FDA compliance
• 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 for PRISYM clinical trials 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