Managing the investigational product lifecycle can be difficult without a system designed specifically for that function. It is a complex process with high stakes – one wrong move can halt a study, put subjects at risk, or open up a sponsor for a compliance audit.
The struggle is that product tracking systems can be rather pricey and there’s a lot of competition in organizations for IT budget. What we’ve advised clients in this situation to do is to consider adding a module to their existing clinical trial management system (CTMS).
A CTMS is a natural fit for an investigational product tracking module because the study, site, and subject data is already stored there, reducing the need for duplicate data entry and/or expensive integrations. Additionally, adding functionality to an already supported system reduces the overhead costs that come with a brand new system (extra servers or hosting fees, additional training for IT support staff, additional licenses, and so on).
Oracle’s Siebel CTMS is an ideal candidate for such a module because of how configurable the Siebel platform is. Siebel CTMS can be enhanced to include features like:
- Monitoring stored products until they’re ready to ship
- Scheduling shipments from the manufacturer to drug depots and from depots to sites around the world
- Tracking the receipt of shipments and recording the quantities received, used, spoiled, destroyed, etc.
- Managing the shipment of unused products back to the sponsor for destruction at the end of a study
Functionality like this leads to increased and accurate visibility into the status of your investigational products, improved compliance, and complete traceability. And, adding it to a system you already have greatly improves user adoption, in addition to the time and cost savings I mentioned above.
Perficient has added an investigational product tracking module to clients’ instances of Siebel CTMS at a fraction of the cost of a separate solution. For a closer look at this add-on module, send us a note.
