Wipro Technologies has developed a secure cloud-based solution ‘Clinical Collaboration Portal’, to help its customer base of Drug Development Owners (Sponsors), CROs (Clinical Research Organizations), clinical sites and regulators to significantly improve collaboration capabilities for multi-region clinical trials.
Clinical trials for global studies require close collaboration between partners and regulators across multiple regions to conduct multi-region clinical trials effectively and rapidly. The portal platform will reduce the clinical trial cycle time by 20-30% by speeding up communication and document exchanges between all the stakeholders who are the sponsor organization, CRO staff along with clinical site coordinators and principal investigators. The portal platform can be leveraged as an enterprise level solution to increase efficiency and lower the cost of clinical operations.
There is an intensifying need in the market for a platform that can centralize information, manage financing, facilitate accurate reporting, automatic scheduling and provide the ease of patient recruitment. This need for increased collaboration in clinical trial operation elements, coupled with the need to cater to different styles of recruiting patients, for different therapeutic areas and identifying the best clinical sites that can perform clinical studies, in adherence with the local regulations, has opened up a potential market for a collaboration portal.
This Wipro portal has the capability to better manage all the data required to conduct a clinical trial that makes up the trial master file – which, in the existing clinical trial model, is dominantly paper based in combination with shared folders across geographies.
By enforcing a common Standard Operating Procedures across the groups which are involved in clinical trials, the Wipro Clinical Collaboration portal helps them to better adhere to regulatory frameworks such as Good Clinical Practice (GCP) guidelines to avoid any oversight in the trial management process.
“The Wipro Clinical Collaboration ‘cloud’ based portal is supported by Wipro’s Rapid Trial framework and very well integrated with leading market products for Electronic Data Capture (EDC), Interactive Voice Recording System (IVRS), Safety, electronic Trial Master File, document management systems and Clinical Trial Management System (CTMS) solutions with a zero CAPEX in a highly compliant, best-in-class system,” said R Srinivas Rao, vice president and Vertical Head – Life Sciences Solutions, Wipro Technologies.
“A platform which enables the exchange of documents and communication seamlessly and in compliance with global standards i.e. CFR (Code of Federal Regulations) part 11, while performing the clinical trials really relieves our customers from worrying about the compliance and validation of any solution used in the clinical trial space and helps them focus better on core trial conduct and efficiency,” he added.