Since 2009, iMedicalApps has given readers the latest in digital health with a deep knowledge of medicine, the mHealth marketplace, and what makes apps work.

Our audience – the largest group of clinicians interested in digital health anywhere on the internet – is pretty tech savvy, too. And they’ve created startups, apps, and platforms, some of which may be the “next big thing” in healthcare.

To showcase these up-and-comers, we’ve decided to create the iMedicalApps Tech Feature.

For our first Tech Feature, we’d like to present a startup founded by Komathi Stem, MSE, a biomedical engineer with a long track record in the pharmaceutical industry, focused on driving the next generation of clinical research.

Their company monARC is an interoperable smart health record platform that passively consolidates clinical data from medical records, images, and labs.

Tell us about the group you’re working with and your own background/credentials.

I am a PharmD and iOS programmer and have been working in the digital health space for a few years and worked in the Clinical Innovation teams at Genentech and Eli Lilly. Our founder, Komathi Stem, has worked for more than 20 years in pharma, with the last 5-7 years working on bringing digital health into clinical trials. The entire multidisciplinary team of monARC hails from drug development, clinical research, app development, data security and patient engagement, and has deep industry ties. monARC’s advisory board is made up of executives from 3M, Pear Therapeutics and Indalo Therapeutics as well as Tufts University.

Tell us about the clinical need that you’re addressing – why is what you’re doing worth doing?

New treatments are greatly delayed during the clinical trial process, with a large bottleneck being at the design and enrollment stage of clinical trials. monARC is able to inform clinical trial designs to avoid costly amendments, pre-qualify patients to exponentially accelerate patient enrollment, and enable connected clinical trials to broaden access to a wider and more diverse subject population.

Tell us about monARC. How does it address the clinical need?

monARC activates Patient Research Networks powered with a transformative data collection and analytics platform that converges data from clinical care and digital devices (smartphones and sensors) into a Smart Health Record. The Smart Health Record is a holistic, computable, longitudinal medical record that generates deep insights to inform trial designs and stratify patients. In addition, the platform leverages telemedicine and mobile technologies to facilitate trial participation from anywhere, anytime.

What makes what you’re doing innovative?

monARC Bionetworks is creating a new data-sharing economy where patients can directly donate their data and participate in clinical trials anywhere, anytime. The result is faster, better, cheaper clinical trials, with patients more easily able to join trials and bring treatments to market faster. Our approach will accelerate trial recruitment, improve retention and enroll a more diverse study population. It will also generate novel endpoints and evidence for remote care models. The platform will save biopharma companies 3-4 years of development time valued at $1M a day and generate $80M in operational cost savings per program.

Does your product need FDA approval or any other regulatory approval?

We have built our platform to generate FDA submissible data. So trials run using our technology will be able to submit their trial results to the FDA.

How does your product protect patient privacy? Please explain how you maintain privacy and HIPAA compliance for the health data gathered? Do you sell or share patient data (identified or deidentified)?

Our product adheres to both HIPAA and 21 CFR Part 11 compliance, ensuring that patient privacy is protected. This is a large area of focus for us as a company. Any data that gets sold to researchers is at a population level and is de-identified. If we qualify patients for trials, we give them the opportunity to decide if they’d like to join it before sending over their information to the trial.

What advantages does monARC offer over other digital-health companies that have developed digital cohorts like Sage Bionetworks or third-party developers like Medable, who can support similar infrastructure for researchers to build these cohorts themselves?

monARC is an end-to-end platform (from recruitment to connected clinical trials) that gives pharma an easy adoption, rather than only being utilized as a point solution, such as the companies you had listed. Also, we are already executing on clinical trials and have more around the corner, showing that we have a solution that goes beyond other offerings, witnessed by our early adoption. By creating a large Patient Research Network that easily allows patients to share their data with researchers, it is a strategy that is easier for both patients and researchers to get on board with because it doesn’t require every research organization within IPF to have to create their own networks, they can now collaborate together

For monARC Bionteworks

Komathi Stem, MSE

Komathi Stem, MSE

Komathi is a biomedical engineer with over 24 years of drug development expertise across multiple therapeutic areas. She is passionate about leveraging digital technologies to empower patients and enable greater collaboration to exponentially transform clinical research to be faster, cheaper and accessible to all patients. Senior leader, Eli Lilly, Astra Zeneca, Amgen and Genentech and an Innovation leader at Roche. Commercial, Operations, Regulatory, Portfolio Management and Innovation.

Sunny Nagra, PharmD

Sunny Nagra, PharmD

While obtaining his PharmD, Sunny noticed the need for the healthcare industry to embrace the use of technology to enable patients to live smarter and healthier lives. Sunny has spent time with the innovation groups at both Genentech and Eli Lilly, helping to create the next generation of clinical trials.

To learn more about monARC, check out their website or the app.