At the Drug Information Association’s annual meeting, Pharm Exec got a few minutes to talk with a little software company named Microsoft’s about its work in creating integration between electronic data capture [EDC] and electronic health records [EHR], and its new Amalga technology.
Electronic Data Capture Integration
“I don’t think electronic data capture has evolved to where it should be yet – It’s not an adult yet,” said Microsoft life science strategist Les Jordon. “Companies say that they have a mature application, which is true, but we’ve got a lot of mature applications and everyone’s spin on EDC is slightly different. Where we see EDC going is really a merger of clinical trials management, which includes project management, electronic data capture, and integration with electronic medical records.”
Microsoft expects this merger of data sources will provide a seamless environment, so that pharma companies can find trial sites a lot easier and lower the expense of recruiting trial sites and maintaining them.
A pharma company can look at the different sites they want to use and choose one that uses technologies that can be joined with an existing EDC system. All it has to do is connect its electronic medical records with a Web service to an in-house EDC system. That significantly lowers the cost of entry for a trial site to be used.
One of the biggest problems with electronic records is the lack of standards. Take one look around DIA and you see dozens of companies touting their wares, but none of them work together. So a trial site must deal with a different system for every client and vice versa.
Microsoft is working with the Clinical Data Interchange Standards Consortium (CDISC) and other facilitators to adopt a standard for integration of the EMR and EDC. “Are we there yet? No,” said Jones.
The way the integrated platform will work is that the EMR will call into the EDC system and state that it has a patient on a particular clinical trial that needs a specific form to fill out. The EDC system then will send the form over to the EMR, which then will display the form in a Web browser. The physician can then fill out the form while the patient sits in the visit. Once completed, the form is then sent back to the EDC system.
“It’s the evolution of what we call single source – a project Microsoft started with CDISC seven years ago,” Jordan said.
Microsoft is pushing an open standard that will work with any system over Web services using CDISC and SAFE standards.
“We’ve been pushing along the players and trying to get some harmonization in the IHA to get this done,” Jordan said. “For us the biggest hurdle has been the development of standards. One of the beauties of open standards is that they are open, but one of the downfalls of open standards is that they are open. That’s the problem. We have to drive consensus between parties with different interests.”
Amalga Life Sciences
Microsoft revealed new information about its Amalga data integration/aggregation engine that allows companies to point data from disparate sources into Amalga and return relationships among the data.
The key word is relationships. It’s an inference engine that looks at all the clinical trials that are going on, existing early stage discovery data bases, lists of publications – any source that the company would want to point it to – and see what the relationship is between the data.
The program visually shows all the different ways data is related. For instance, there might be a biomarker that a particular compound in a certain set of individuals would lead to a particular adverse event, Jordan said. “We can prescreen for that and tell physicians not to prescribe to patients with this particular biomarker or that it’s more effective for patients with a particular biomarker,” Jordon said.
The system was boosted by Microsoft’s recent purchase of Rosetta, a genomics analysis software, previously owned by Merck. No word yet on how that data system will be incorprated into Amalga.