Purdue Pharma has chosen Microsoft and Interse to help automate and enhance clinical trial document management.  This solution is based on Microsoft Office SharePoint portal server 2003 and Interse’s iBox metadata management and search solution. Purdue can now use metadata management and search capabilities to streamline processes associated with document management. Anthony Sclafani, Purdue’s assistant director, collaborative business solutions, said, “Sorting through file shares was a completely manual process, which was a problem with multiple financial and logistical implications. Those problems are now a thing of the past, as the new document management solution allows users to access important information with just a few clicks.” We recently wrote about another Microsoft partnership with First Consulting Group here.

CDISC is running a course on the Study Data Tabulation Model (SDTM), a specification in the FDA eCTD Guidance as the model for submitting clinical and preclinical data to the FDA in support of marketing applications. The course will be taught by two CDISC veterans, Frank Newby and Mary Lenzen, and held in early August at the San Diego offices of i3 Statprobe.

Advanced Clinical Software (ACS), which provides clinical trial management software (CTMS), announced that William Beaumont Hospital’s Royal Oak Campus, one of the largest hospitals in the U.S., has chosen ACS’ StudyManager software as their end-to-end solution for managing clinical trials. The Michigan hospital chose the CTMS solution to increase efficiency and standardization of methodology for managing clinical trials across multiple therapeutic areas. With its web-based architecture, StudyManager allows users to create a centralized clinical trial database infrastructure to be deployed across different departments. It provides managers with financial and budgeting tools to determine the financial impact of participating in a study. Bruce Schatzman, president of ACS, said, “StudyManager is a natural choice for William Beaumont because of their need to efficiently manage such a large number of clinical research activities in real time.”

Green Mountain Logic (GML), which provides targeted technology solutions to the life science industry, has signed an agreement with OmniComm, an eClinical software and services company, to develop an interface between GML’s LabPas CT and OmniComm’s TrialMaster electronic data capture (EDC) product. LabPas CT electronically captures validated data during recruiting, on the clinic floor, in the lab and through export to EDC. TrialMaster is an EDC software solution that allows clinical trial sponsors and investigative sites to collect, validate, transmit and analyze clinical study data, including patient histories, patient dosing, adverse events and other clinical trial related information. The new interface will transmit validated Phase I clinical trial data directly from LabPas CT into OmniComm’s TrialMaster. Stephen Johnson, senior VP of business development said, “Phase I clinics in particular will benefit tremendously from this partnership, as real-time bedside data capture and integration with instrumentation is crucial to their decision-making process.”

Premier Research Group (PRG) announced the acquisition of ARS and D-Target, which continues PRG’s stated strategy of building an international business both organically and through strategically placed acquisitions. ARS will immediately strengthen Premier Research’s presence in the growing New England biotech market, while D-Target’s medical device focus will bring expanded expertise in that area to both U.S. and European customers. ARS also brings well established capabilities and expertise in Oracle Clinical. Simon Yaxley, chief executive officer of Premier Research said, “Both offer a number of complementary synergies to the enlarged group and further strengthen Premier Research’s position in the international CRO market.” ARS and D-Target are the fifth and sixth acquisitions since Premier Research became a publicly-traded company in late 2004.

Could a third of physicians have electronic medical records (EMRs) by 2011, four years from now? Personally, we wouldn’t bet on it. But that’s the prediction of a new survey by the Millennium Research Group. “The success rates of EMRs vary. Many physicians lack the training required to efficiently utilize a sophisticated EMR system,” said April Chan, an analyst at MRG. “A number of vendors are now introducing more streamlined and simplified versions of their EMR systems to increase physician usability and acceptance. The software-as-a-service delivery model will be an attractive alternative for small- and medium-sized practices.”

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