PRISYM ClinTrial has positively impacted the streamlining of label processes for clinical trials companies requiring randomization and complete patient pack labeling
PRISYM ClinTrial is a clinical trials labeling package that provides specific features for managing randomized labels and records. It securely and accurately manages clinical trials data for supplies and complete patient kit/patient pack labeling.
PRISYM ClinTrial is a turn-key solution which follows clinical trial protocol to help in passing industry specific audits including FDA. With inbuilt security, it only allows authorized users to create, edit or print labels as well as monitor their activity.
The software supports clinical trials phase label printing, patient stratification, patient removal during a trial, multiple center, visit and treatment logging management, complete randomization based on treatments and stratification and product lifecycle documentation.
Features & Benefits
PRISYM ClinTrial has positively impacted the streamlining of label processes for many clinical trials companies.
- Management of on-demand labeling processes for kit/pack labeling – It offers one complete solution across the business from manufacturing labels to integrating with existing applications
- Open, randomized or scrambled trials to support your mechanism for clinical trials labeling
- Ability to meet global regulations including FDA compliance requirements
- Proactive review and approval work engine that reduces the likelihood of production errors and product recalls
- Auditable security protocols to control user permissions including design, review and approval privileges
- Links to ERP and MRP systems to ensure that all information from production can be delivered to the label at time of print
- Over 500 printer drivers within the software, specifically written by our expert developers to ensure high speed data transfer to a wide range of devices including thermal transfer printers, inkjet coders and RFID coders
- Integration with Vision Inspection solutions for post-print compliance
- Auditable security protocols and lifecycle documentation based on the GAMP 5 Model to gain GMP compliance by meeting all guidelines
The PRISYM ID team has specialist knowledge to make sure you know the “do’s and don’ts” of clinical trials label design and lifecycle management.
“Initially, there was no suitable system in place for printing labels, especially labels for randomized studies and projects. We knew, however, what level of quality we required and the PRISYM ID system not only delivered, but exceeded our expectations.”
- 30 years' experience in the labeling and auto-identification market, working with a range of companies from start-ups to blue chip organizations
- In-house test and validation team to support all compliance requirements and lifecycle documentation
- Accredited as a GS1 solution provider to make sure our clients produce compliant GS1 barcodes
- Experienced consultancy team to aid you with solution implementation, configuration and training
- Specialist expert developers building specific printer drivers to ensure high speed data transfer to a wide range of devices
- 24/7 software support services that will seamlessly manage your company’s needs from troubleshooting to upgrades, re-installation, and configurations.
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