CliniOps Decentralized Clinical Trials (DCT) solution

Leverage technology to take your trials where your patients are
CliniOps Decentralized Clinical Trials (DCT) solution Leverage technology to take your trials where your patients are

CliniOps Decentralized Clinical Trials (DCT) solution Leverage technology to take your trials where your patients are

Avik Pal - Founder & CEO - CliniOps

Avik Pal: The mind behind CliniOps

Avik Pal, the founder, and CEO of CliniOps, is an IIT Kharagpur graduate and an MBA from the University of San Francisco. At the start of his career, he worked with two successful startups in Silicon Valley, California. In his second startup, Avik led global delivery, where he managed several fortune 500 clients. Avik was the President of the IIT Alumni Association of San Francisco Silicon Valley Chapter. He is also a board member at iKure, a HealthIT startup, for the last-mile healthcare delivery.

What laid the Foundation of CliniOps

In his previous company, many of the clients that Avik managed happened to be Pharma companies, and he gradually developed an interest in this domain. His association with iKure helped him appreciate and understand the challenges of collecting good quality data at the point of care, in resource poor healthcare settings. His interests developed further, when his wife, Dr. Reshmi Pal, transitioned from a medical profession to a clinical researcher, who introduced him to the field of clinical trial. A deeper understanding of the clinical trials made him aware of the large amount of data involved in the trials and the challenges around collection of good quality source data at the point of care, and that is where the idea of CliniOps took shape. To learn more, Avik participated in some of her studies as a healthy volunteer to better understand the challenges at the clinical trial centers. The first app he developed was to tackle the first issue he faced at the clinical trial center: signing informed consent. Next, they created an electronic data collection (EDC) to digitize the case reports forms in the same software, and with time it gradually developed into a robust unified platform for conducting clinical trials. In this journey, Avik was joined by his co-founder and CTO, Yerramalli Subramaniam, and Partha Chakraborty, who are both IIT Kharagpur alumni, and they all knew each other since college days.

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Avik Pal & Yerramalli Subramaniam

Understanding the Working of CliniOps Platform

CliniOps provides an unified platform solution, that can replace several siloed databases that are currently needed to run clinical trials. Their user-friendly interface provides end users with Case Report Forms on a tablet for easy collection of data at the point of care. Furthermore, data can be collected in complete offline mode and later synced when internet is available. Their system eliminates several manual errors involved in the traditional form of data collection resulting in high-quality clean data irrespective of the infrastructure and connectivity challenges at site locations. Talking about the high quality of data, Avik also mentions that the data collected is pre-mapped to FDA-compliant data standards. So as soon as the data collection is complete, it is ready for analytics.

Yet another breakthrough in clinical trials is CliniOps’s ability to provide real-time statistical analytics. In the traditional method of data collection for clinical trials, it takes several hours to several weeks after data lock to obtain an analysis ready clean dataset. Whereas in the digital platform by CliniOps, the data is available in real-time. Avik recalls an incident that happened during their work with the Gates foundation. Nobody expected to see the graphs and charts until about a year later; so they were amazed when they saw the graphs and charts with rich analytics being populated in real-time on CliniOps portal, from data collected around the world on the same day the study started. The success of their platform created a lot of traction within the Bill and Melinda Gates foundation. This ability of having real time insights on the data has further benefits, says Mr. Pal. In a clinical trial that was supposed to recruit 38,000 patients to meet the primary end-point, real time analytics by CliniOps showed that primary endpoint was achieved with only 26,000 patients; thereby saving significantly on additional recruitment.

Journey of CliniOps

The first phase of their adoption was in academia. CliniOps worked with top educational institutions like Stanford, Harvard, Boston University, Boston medical center, Washington University School of Medicine, to name a few. During that time, Avik co-authored several publications with Harvard and Boston university professors. In the Second phase, they worked with large foundations like Bill and Melinda Gates Foundation, Pediatric Aids foundation, National Kidney Foundation, DNDi et al. The Gates study in particular was a huge success. It was a massive study involving 38,000 patients from multiple countries, and was completed in less than two years, Bill Gates himself tweeted about the study as a ‘Massive Success’. In the third phase they gradually penetrated the industry and was adopted by the mid-market segment for their FDA regulated clinical trials in pharma, biotech, and medical devices. After the pandemic, they penetrated high-end pharma companies like Roche and Novartis.

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Avik Pal & Partha Chakraborty

Hurdles Along the Way

When CliniOps initially started, it faced many challenges and stiff resistance with respect to technology adoption from the traditional sites. Avik mentions that in a study on lymphatic filariasis for the Bill and Melinda Gates Foundation, the site in Indonesia strongly resisted the mobile based data collection approach; but as they started using it, they realized that using the platform was not only simple but also easier than following the traditional method with all the manual paperwork. Avik proudly states, “Indonesia was the first site that completed their enrollment quota of over 6,000 patients, which was the most resistant to begin with”

It took less than 18 months for CliniOps to complete the study and present the results at the ASTMH conference in Washington, DC, with the Gates foundation. The reports of the study were published in Pubmed and several high-end journals.

Milestones in the Journey Of CliniOps

According to Avik Pal, one of the first milestones of CliniOps was the acceptance of their solution by the regulatory agencies. Avik states, “At the end of the day, when you run a clinical trial, the end product you give to the FDA is data”. I am a humble engineer, not a scientist, doctor, or clinician, and our goal was to ensure that significant efficiencies are achieved through the use of smart technology and data science. It was indeed very satisfying when the first study that was conducted on our platform received the FDA approval”.

Another milestone for CliniOps is the recognition from Gartner, the highly reputed industry analyst firm. CliniOps was on Gartner’s ‘Hype cycle for life sciences R&D’, for three years in a row. Talking about the study they conducted for the Bill and Melinda Gates Foundation on lymphatic filariasis, Avik mentions an article published by the health minister of Kenya. If young unmarried women in Kenya get lymphatic filariasis, they are considered unworthy of getting married. The article documents the story of a woman who had lymphatic filariasis. She raised her hand during an assembly and started crying. Because the drug came early, she got treatment and cured in time, that helped her get married and now has her own family. Avik Pal says, “What really touches your heart is when you make a difference in someone’s life. Although we are not developing the drugs, our software helps bring a drug faster to the market, and in the process makes an impact in the lives of patients and their families.”

CliniOps Plan for the Future

CliniOps’s vision for the clinical research industry is to establish a continuum of care from the bench to the bedside. “This continuity is what we want to achieve through CliniOps, and we are working towards it", says Avik.

Although the initial aim of CliniOps was to improve efficiency and accuracy in the data collection process of clinical trials, the scenario is changing drastically post covid as massive changes are occurring in clinical trials process and procedures. In the present scenario, most patients prefer the convenience of their home and do not want to come to the hospital for their visits. “Patients are already suffering, and you are adding on to their burden by asking them to take a cab or drive to the hospital”, says Avik. Therefore, to make our clinical trials more patient centric, the need of the hour is Decentralized Clinical Trials (DCT) which helps you take your trials to where your patients are. Even before covid, CliniOps had the option for DCT, but its adoption became much more widespread post-Covid.

According to Avik, the implementation of DCT comes with its own set of issues as people needs to understand that a trial is neither 100% centralized or decentralized, but is generally a hybrid of the two as some trial procedures can happen at home, while some needs a hospital setup. CliniOps offers a technology that can help research centers conduct hybrid trials seamlessly. They use cutting-edge technology, telemedicine, and other advanced solutions to bring the trials to the patients. CliniOps plans to take this beyond by optimizing the process. “We are focused on continuum of care from clinical research to clinical care, and provide innovative technology that would ensure this continuity for those participating in clinical research”, said Avik Pal.

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CliniOps offsite meeting

CliniOps During Covid

CliniOps added several feathers to its crown when its software solution helped bring a drug faster in the market which would have otherwise taken much longer with traditional methods. When the pandemic hit the world, pharmaceutical companies raced against time to develop and deploy effective drugs and vaccines in a not-so-ideal scenario. CliniOps came to their rescue and helped conduct clinical trials to bring new drugs to the market.

Avik Pal recalls one such incident when they worked with Biocon. Just before covid, they met Kiran Mazumdar Shaw, the chairperson of Biocon, and presented their software to her, which she liked. As covid struck, Biocon wanted to start clinical trials with covid patients in critical conditions. However, it was not easy as the situation was quite scary, patients were dying, and the risk of getting infected was high. The main obstacle they encountered was getting the informed consent form signed by the patients, without which they could not even initiate the trials. The reason was when a covid patient was admitted in the hospital, most of them were not in a condition to sign the informed consent, and with the social distancing norms, those accompanying the patient was not allowed inside the hospital. Initially, the trial was supposed to start in August, 2020 when covid was at its peak. But without consent, Biocon could not get started and were stuck for about four months. However, after CliniOps joined the project, the study setup activities were completed in just four weeks and was implemented across hospitals in several languages. Legally Authorized Representative of the patient (LAR) located anywhere in the world were contacted via CliniOps’s video consenting module and were provided details of all trial information following which they and the physician digitally signed the consent form. This completed the consenting process according to the ICH-GCP guidelines for treating a patient. CliniOps seamlessly implemented the software in 12 different languages in over 26 medical institutions across India, including AIIMS and several government hospitals. Their software helped complete the clinical trials in a challenging situation and get DCGI approval for the drug.

A Word of advice for a Newcomer By Avik Pal

Talking about the time when he first started, Avik Pal mentioned that there were already several players in the field with excellent solutions. However, all of them had one limitation- all the solutions were developed as siloed applications and were designed for ideal conditions. Therefore, they did not serve their purpose in resource poor settings like a clinical center in sub-Saharan Africa, or a government hospital in a LMIC country. The challenge was to create a solution that would work irrespective of resources and facilities. The one piece of advice Avik Pal would like to give to any newcomer is, “First talk to your end user, understand their pain, their challenges, and then write your first line of code. It’s important to first understand the problem really well before you develop the solution”.

Callout Quote:

“We are focused on care continuum, from clinical research to clinical care, and provide innovative technology that would ensure this continuity for those participating in clinical research”, said Avik Pal, CEO, CliniOps.

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