08/06/2021
Exec Chat: eClinical Solutions Clears Muddy Clinical Trial Waters :: Medtech Insight
Exec Chat: eClinical Solutions Clears Muddy Clinical Trial Waters 08 Jun 2021
INTERVIEWS
by Barnaby Pickering barnaby.pickering@informa.com
Executive Summary Increasing clinical trial complexity goes hand in hand with increased reliance on advanced-analysis software. Raj Indupuri of eClinical Solutions believes the company's product will lead this emerging market.
Source: alamy
Boston-based eClinical Solutions has developed a suite of digital tools to enable users to analyze clinical trial data easily, quickly and accurately, taking away much of the tedious manual work previously required.
08/06/2021
Exec Chat: eClinical Solutions Clears Muddy Clinical Trial Waters :: Medtech Insight
Raj Indupuri, Bharat Agrawal and Bob Arnesen founded the company in 2012 after they recognized the challenges posed to researchers by the ever-increasing volume of clinical trial data. Along with the glut of legacy software and poor record management between facilities, trial organizers were struggling to analyze the growing volume of data. (Also see "Data Gathering Devices Offer Big Potential In Neurological Drug Trials" - In Vivo, 27 Apr, 2021.) "We believed companies would need modern data infrastructures to bring all this data [obtained from clinical trials] together, so that they can actually harness the value of this data and transform it into something meaningful for intelligent decision making,” eClinical CEO Raj Indupuri told Medtech Insight. At the core of eClinical is its principal product, elluminate, software designed to “make your job easier” as a researcher. The cloud-driven software allows researchers to “drag-and-drop" data into its interface, where it is automatically screened for errors, and formatted for analysis. Once trial researchers have obtained their data and input it into elluminate, they have the option to request eClinical to perform statistical analysis on the data. This approach allows for academics and pharmaceutical companies to have a clear data pipeline during trials, Indupuri explained. “We address the complete data lifecycle, from ingestion to consumption, rather than just a component of a modern data lifecycle.”
“Trials are only going to get more complex, and the amount of data is only going to increase." – Raj Indupuri The software was designed with clinical trials in mind. “Our platform works for any type of trials – drugs, clinical or otherwise. We’re agnostic in that sense,” Indupuri said.
“We have our own connectors, [software that links other software together,] so we can bring many electronic digital records systems together,” he said. “The platform is built in a way so that you can use the same capabilities irrespective of the type of the trial, providing the same level of insights and analytics.” This addresses a large challenge faced by clinical trials. Each trial collects vastly different data covering a huge range of parameters so normalizing data prior to analysis often proves difficult. The company also pays attention to data protection, which has become increasingly important because of European regulatory changes. “Right from the beginning, we started with respect to [General Data Protection Regulation]. GDPR takes it to the next level in terms of the controls that are needed around data privacy and information security,” Indupuri said. “We have a tight set of controls which limit the amounts of personally identifiable information that can be entered.”
The Future of SaaS and eClinical Indupuri was keen to highlight that software-as-a-service (SaaS) will likely become the prevailing business model within the medtech and pharmaceutical industries. “Trials are only going to get more complex, and the amount of data is only going to increase. It’s an exciting time for the industry.” The pandemic “has been a catalyst,” he said. “Companies are now investing more in transformation issues and data modernization initiatives.”
08/06/2021
Exec Chat: eClinical Solutions Clears Muddy Clinical Trial Waters :: Medtech Insight
“Industries will adopt more and more of these cloud-based systems to take advantage of the strong leadership in this space – it's very exciting.” – Raj Indupuri Over the next five years, Indupuri said that he expects eClinical to grow its market share to become the industry leader. He said the company will take advantage of its rapid innovation cycle; eClinical releases three major updates per year. eClinical is free to innovate its back-end artificial intelligence without needing to undergo regulatory approval repeatedly. Therefore, elluminate can closely follow clinical trial trends, ensuring that its analytical platform and user interface are tightly conformed to both regulatory and industry requirements, while decreasing the time for which researchers may have to wait for needed improvements or integrations, he said. Indupuri highlighted the need for innovation in the clinical trial sector. "Science has been groundbreaking but clinical development has not evolved a lot. There's so much investment in technologies in terms of vertical SaaS to solve these complex workflows,” he said. “Over the next few years, I think industries will adopt more and more of these cloud-based systems to take advantage of the strong leadership in this space – it's very exciting.”