Pharmaceutical companies today face a problem in form of the complexity of managing the increasing number of bio-specimens (tissue, blood, DNA, RNA, etc.) generated during the clinical trials process. With the heightened regulatory and privacy compliance necessitated by Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), 21 CFR Part 11, Health Insurance Portability and Accountability Act (HIPAA) and Internal Review Board (IRB) requirements, they need a solution that accurately tracks patient consent, HIPAA waivers, laboratory conditions, and electronic signatures.

Furthermore, as organizations recognize the additional value of utilizing samples during the discovery process for pharmacogenomics and pharmacoproteomics, solutions need to be able to easily store, locate, and access vital biospecimens along with critical genomic, proteomic, and phenotypic information without difficult system integration.

In creating vSTMS™, we partnered with proven software development experts and applied practical experience in global clinical sample management, bio-banking research and manufacturing to develop the most sophisticated system on the market. vSTMS™ follows HIPPA and FDA Title 21 CFR Part 11 guidelines. In addition to passing a rigorous internal testing process conducted by our company, vSTMS has met or exceeded all requirements of every independent audit conducted by bio-storage technologies’ clients. It also offers a query option employing ICD and SNOMED coding systems.

Specimen Tracking and Management System for Pharmaceutical (vSTMS™-Pharma), the web-based system enables you to monitor sample and specimen activity, view audit trails and documentation, view your entire stored inventory, schedule shipments and run customized reports on materials stored at your facility ensuring you can always access information about your stored biomaterials from your intranet and/or internet.

• Web based easy to use interface.
• Supporting GLP operations.
• Complying with regulatory and legal requirements.
• Coupling specimen management with integrative analytics.
• Allows for specific level of security provision to each user.
• Run tests on the given specimen and keep records of all such tests, their pre-condition, post conditions and results.
• Efficiently place annotated samples into inventory.
• Bar code tracking system to find individual units/vials/aliquots within a box.
• Record temperature history if material is moved in inventory.
• Maintains the material distribution history.
• Provision of compliance - the lab result entries are double-checked for accuracy.
• Rich support for a web calendar that notifies user of all important activities on monthly, weekly and daily basis.
• Provides high levels of performance in handling large Volumes of data and simultaneous users.
• Logs application exceptions in a consistent format to effectively diagnose application problems.