Research and Development

There are numerous areas where Princeton Blue solutions can improve the efficiency and productivity of the drug development process. The one that stands out to benefit the most is during Phase III clinical trials. This phase has the highest number of people involvement, both internally and externally. Information must flow in the most efficient way possible between trial sponsor, trial management team, trial investigator, the IRD, the participating sites and other 3rd parties involved in the trial, including IVRS and EDC vendors.

Communication between these parties is mostly batch file oriented and in some cases these files are sent every 2-4 weeks. We’ve also seen situations where external IVRS vendors provide printed reports which are then re-entered manually into the sponsor’s Clinical Trial Management System creating a lag in some cases of up to 6 weeks. With Phase III trials running upwards of $750,000 per day, a 2-6 weeks delay in receiving site information from IVRS and EDC vendors does not provide the trial administrators with the visibility they need to run it efficiently. And every day lost in the trial is a day lost from the monopoly marketing stage of the drug. There are many other similar examples within the drug development process where standards based communication between the internal and external parties can significantly shave weeks and months off the drug development lifecycle creating significant value for the Life Sciences industry.

Some of the areas where Princeton Blue can add value within R&D include:

• Workflow-based protocol authoring
• Standards based messaging (using an Enterprise Service Bus) between external IVRS and EDC vendors and the various internal applications, including CTMS
• Business Process Management (BPM) centric approach to Adverse Event reporting ensures visibility and proactive alerting during this FDA watched process