eClinical started as a services organization in 2006, a time when the pharma industry was witnessing sweeping changes, the most prominent being a steep rise in the adoption of clinical systems. “This directly resulted in utilization of multiple service providers, adherence to complex regulatory requirements, and adoption of data standards that gave rise to new challenges,” recalls Indupuri. These challenges, ranging from trial data dispersed in different formats and systems to support efficient reporting and analysis of the data spurred eClinical into developing software, in 2010. Since then, the company is focused on leveraging cloud and analytics and continuously adding innovative capabilities into elluminate.
elluminate utilizes secure cloud-based architecture and offers scalable management of clinical data as well as efficient computing for data analytics. Our end-to-end platform enables clients to seamlessly import data from different sources, formats, and systems into one central repository for self-service analytics. “elluminate requires no infrastructure at the client’s side and successfully delivers mature data integration capabilities,” assures Indupuri. The solution doesn’t require tedious customizations which take a long time to implement along with the spending of massive resources and efforts. Elluminate supports multiple use cases from Risk Based Monitoring (RBM) to Safety Signal Detection and is seamlessly interoperable with other systems. “If a clinical system outputs data in CDISC ODM format, for instance, elluminate can easily import it,” affirms the CEO.
We, at eClinical, strive to ‘liberate’ the cloud and analytics technologies, empowering our clients in the process
In reporting and analysis, if the client uses Study Data Tabulation Model (SDTM) data model, elluminate empowers the clients to integrate the data with a few clicks and publish it. Within a few minutes, clients have access to advanced visualizations which enables decision-makers to look for outliers or identify new patterns. The data that is published is governed and controlled to avoid any integrity or quality issues. “We incorporated several capabilities within the platform to support this governance including meta data management, compliance with standards, and audit trail to ensure the data flows from the source to analytical modules seamlessly,” says Indupuri.
A Boston-based Biotech company, focused on oncology-related clinical trials, was struggling to build databases and designing Case Report Forms (eCRF) for efficient collection. The client’s initial solution provider was unable to provide competent design practices which led to the databases getting too complex to utilize. eClinical, once called in, refurbished the databases in terms of collecting the data elements, and combined complex eCRFs and converted them into simple usable ones. The technical services team extracted data from the redesigned databases and transformed it into useful information while the sponsor team accessed the data and analyzed it easily utilizing elluminate. The client thus gained insightful visibility into tumor response rates and other trends.
eClinical will continue to leverage cloud and analytics to deliver a combination of products and services as, “we firmly believe, to maximize the potential of these technologies, is the Holy Grail for success in pharma and saving lives as never before,” concludes Indupuri.