Global IT outsourcing firm Wipro Technologies has introduced its secure cloud-based Clinical Collaboration Portal that it says can reduce clinical drug trial time by 20 to 30 percent.
The Clinical Collaboration Portal is a mixture of clinical data capture, electronic data management and trial management. Researchers can also use the portal to order trial equipment.
In building the portal, Wipro wanted to create a way for pharmaceutical companies, drug sponsors, clinical researchers and regulators to communicate easily using electronic messaging such as SMS texting. It also allows users to exchange documents in real time using a single interface, rather than using snail mail and shipping services.
"There's a need for all these people to communicate through one single hub," R. Srinivas Rao, vice president and vertical head for Wipro's Life Sciences Solutions, told eWEEK.
Avoiding snail mail and shipping services can save many years of time in the clinical trial process. Transferring documents using these methods takes up to five or six days, according to Rao.
"Currently the documents collected during the clinical trials process are circulated today via regular mail or leading couriers in each region," he noted. "This approach is both time- and cost-intensive."
Using the Wipro portal, cycle time for submission and review of documents can be reduced to one to two days, Rao said.
"This reduction directly impacts the clinical trial cycle time, which will improve the trial efficiency and reduce the overall time investment," Rao explained. "This in turn can reduce costs for the organizations that have commissioned the trial."
The portal will also help improve communication among these groups in multiple regions, including North America, Asia and Europe. It creates a standard operating procedure for uses in these areas and creates reports of how trials are progressing globally.
Every time an adverse drug reaction, called a SUSAR (suspected unexpected serious adverse reaction), occurs during trials, researchers must inform all parties involved, a process that can increase the overhead of trials, according to Rao. "Through this collaboration portal, the SUSAR distribution can be done electronically without incurring any courier or mailing cost, and the acknowledgments can be tracked electronically," he said.
The Clinical Collaboration Portal provides a central location to manage financing for trials, schedule trial sessions, manage recruitment of patients and organize accurate reporting of trial results.
It also allows users to adhere to regulations. It follows U.S. FDA rules on electronic data capture and signatures, Rao said.
"Our portal helps all the trial participants including researchers consolidate critical trial-related communication and documents," he explained. "Whenever there are protocol violations or deviation, they can immediately communicate this via the portal without having to wait for the system."
Introduced on June 17, Wipro's portal is built on Microsoft SharePoint 2010 and SQL Server 2008 and works with Oracle clinical data management software.
On June 20, Oracle introduced its Health Sciences Trial Center application, which provides a single console to view multiple drug trials.
The Clinical Collaboration Portal also works with other vendors' products to handle electronic data capture, interactive voice recording and document and clinical trial management.