Zircon Technologies: Accel EDC

by Vikas Vavilala

Automated eCRF population and real-time monitoring for clinical trials.
Carmel, United States HIT Drug Development Equity Raise

All Team Company Physicians Hospital Partners Mission Innovation Details Investor Info Due Diligence Docs Supporters Comments Updates

About our project

The problem we solve:
Currently in clinical trials there is a duplicate data entry problem. Research staff at clinical sites (e.g. hospitals) enter patient visit data once in the EMR (for the hospital), and again enter it into the EDC system (for the trial). This leads to several problems. It takes additional time & resources from the site's staff to perform another round of data entry that could have been spent with patients. Further, trial managers at the pharma company and/or CRO only see the data once it's entered in the EDC system. Given the lag of a few days to a couple weeks of when the patient is seen and the data is entered into the EDC system, this can create a significant delay. This delay causes multiple further issues: not only is the sponsor losing 6-7 figures of revenue daily, but they don't have insight into overall trends like site-level protocol issues, adverse events, and efficacy.
About our solution:
Our solution works by integrating with EDC providers and automatically populating the CRF forms for a given trial based on relevant EMR data. Here's the workflow: during a patient visit, research staff enter data into the EMR as usual. They then export the relevant PDF/CCDA files, instantly anonymize them using our desktop application, and then upload them to our HIPAA- and Part 11-compliant web app which is accessed through the EDC. Our NLP technology then extracts both structured and unstructured data (e.g. doctor's / clinical notes) and populates the relevant fields in the EDC that have been setup for the trial. The CRC then verifies that everything is correct - made easy with our linkback features which allow the CRC to view each data field against source - and upload to the EDC. On the other side, CRAs / monitors are able to perform remote data verification by viewing the anonymized source documents and rendered EDC side-by-side, allowing them to instantly spot potential issues.
Progress to date:

We have fully built out our technology: a desktop application that instantly anonymizes source EMR, a web application that allows CRCs to upload the anonymized EMR, the back-end which understands and structures all data (including ICD codes, demographics, labs, and clinical notes) and writes to the EDC. Further, our robust quality management system documents our technological and operational workflows and specifies our compliance with HIPAA and 21 CFR Part 11. Since May 2017, we have been working with 2 EDC companies and, as of September, finished integrating with their systems. Our technology will go live on a maintenance study with an oncology CRO in November, and we have a planned pilot with a university hospital system in Sweden starting early 2018. Our business model is revenue sharing with our partner EDCs who charge for our technology on a per-trial, per-month basis.


About Our Team


Creator: Vikas Vavilala
Education: Columbia University
Bio: Studied economics at Columbia and worked in finance/strategy at Eli Lilly & Co. Working in investment banking at JP Morgan, focusing on tech & healthcare companies and worked on $5B transactions.
Title: Co-Founder

About Team Members

Anirban Gangopadhyay
Co-Founder, BS
Biography: BS/MS from Columbia in computer science. Served as a TA for the advanced machine learning course. Software engineer at Department of Defense with a focus on machine learning.
Title: Co-Founder
Advanced Degree(s): BS

About Our Company

Zircon Technologies
Location: PO Box 35125
Carmel 46032
Website: https://zircontechnologies.com
Product Stage: Ready
YTD Sales: Working on it
Employees: 1-2

How We Help Physicians

Our technology helps physicians, PAs & research coordinators reduce repeated manual data entry tasks, identify errors sooner, diagnose clinical issues through our risk-based monitoring platform, and ultimately improve the patient experience by spending more time with the patient instead of at the computer. We have done over 3 dozen demos with research coordinators who have provided invaluable feedback regarding the design and functionality of our product, and they have had active input into creating a system that worked for them and saved them time. While our system does benefit sponsors, CROs, and ultimately patients, it is our end users - the clinical research staff - that we hope will be helped the most by eliminating manual data entry processes and focusing on the patient & clinical experience.


How We Help Hospitals

By helping the clinical research staff, we help hospitals as well. Particularly, we are passionate about helping community & rural hospitals attract clinical research despite a smaller staff. By eliminating tasks and allowing staff to focus on patients, we hope that they can undertake innovative clinical research just as effectively. Overall, we hope to enable hospitals and research teams identify adverse events through our risk-based monitoring platform ultimately deliver innovative therapies faster.


How We Help Partners

We help three primary types of companies in the clinical research ecosystem: sponsors (pharma), CROs, and EDCs. 

We help sponsors and CROs reduce trial time, monitoring expenses, delays due to protocol issues, ultimately to actualize the promise of real-time monitoring. By removing manual data entry processes at the site level, issues are identified as patients visit the clinical site, not weeks or months later. Our goal is to reduce trial delays and expenses tactically, while enabling faster strategic data-driven decisions around site compliance, safety & efficacy. 


Challenge Mission

Key Milestones Achieved and Planned

Milestones achieved include building out our EMR processing & structuring API/backend, successfully partnering & integrating with 2 EDCs, incorporating language translation at ingest, and building out our quality management system and HIPAA/Part 11 compliance. Our next milestone is successfully executing our pilots with each EDC partner, which we estimate will occur in Q1 or Q2 2018.



Our Competitive Advantages

We currently know of no other competitors, however it is possible for other market entrants. Our technology is fairly novel in that it solves multiple bottlenecks that prevent true remote, real-time monitoring: ability to work with any EMR provider/schema; elimination of a need to go through IT, build a high-footprint HL7 interface, or pay for data from the EMR provider; anonymizing the EMR source; automating the CRF-write process in a user-friendly way (by providing linkback for easy verification and edit tools for the rendered CRF); and enabling remote SDV for the CRA with side-by-side source and CRF analysis. 

Further, we believe our novel strategy of growing with our EDC partners instead of trying to compete against them allows us to more seamlessly and quickly integrate into trials and avoid experiencing a lot of pain while learning about the clinical trial ecosystem and peculiarities.



Barriers to Entry

While we have filed a utility patent on our technology, it is common knowledge that software patents are notoriously difficult to defend. We believe that our proprietary technology, which to date lacks clear competitors, as well as our process for ingesting EMR data and automatically writing to the EDC, is very difficult to replicate. Further, our relationships with existing EDC companies help us greatly accelerate our time to market and put us in a position to solidify early-mover advantage - as we have learned in clinical trials, technology is only a small piece of the puzzle. There are several interrelated entities that must all work together to achieve a successful outcome. The EDC is the center in terms of housing and analyzing all data & reporting for a trial - by plugging into their existing infrastructure, we are able to leverage it as if it were our own. This is a huge advantage over other tech companies that may be employing a traditional go-it-alone strategy. 



Traction, Funding and Partners

We have bootstrapped our company to date. We are looking to raise another $50k of funding to cover our initial costs related to the pilots. 

Innovation Details

Intellectual Property Summary

We have a provisional patent on our core technology and are in the process of filing a utility patent

video pwd: zircondemo

Clinical Information

We have two trials which will start over the next 3-4 months which will provide validation of efficacy in the clinical environment.

Regulatory Status

Our technology is 21 CFR Part 11 compliant, and we do not believe we will be covered by other FDA regulations or require additional clearance at this time.

How we will use the funds raised

We are currently looking for $50k of seed funding. This will cover $20k of AWS hosting fees, $20k of costs (travel, development, site payments), and $10k of G&A costs (specifically for legal and compliance). 

Thank You

Our goal is to accelerate the pace of drug discovery by removing the non-medical barriers in the R&D process. We've focused on an area which is of severe angst to clinical sites around duplicate data entry, which causes many follow-on issues with the trial - most importantly, the inability to receive and analyze clinical data in real-time at the time of patient visits. This can lead to many issues, such as problems with protocol compliance not being discovered and addressed for weeks on end, or even worse, unforeseen adverse events being missed or noticed too late. There can be significant patient harm done, and by enabling real-time & remote monitoring, we hope to empower both clinicians and pharma companies to run clinical trials in the safest, most efficient way possible.

Investor Info

Market Size

We estimate that our total market opportunity is $150M in the US. On average, we expect to charge a blended average of $1,000 / month / trial. Across all trial stages (preclinical to late stage) and types (academic vs. industry), we estimate there are 15,000 trials per year in the US and that the average trial takes 10 months. 

Projected 3 Year Growth

Over the next 3 years, we aim to partner with 30 EDC companies who work on an average of 100 trials/year. This represents an annual revenue runrate of $27M and 20% market share (we assume we share 10% of revenues with our partner EDCs). In our first year, we hope to have completed trials with 3 EDCs (already signed with 2), with many more EDCs being signed up during our second year. During our third year, we hope to significantly grow our presence within each EDC by working across all trials that are going through their respective systems.

Revenue Model

As mentioned above, our revenue model is to charge license fees on a per trial, per month basis to sponsors & CROs through the EDC. We assume that, based on what EDCs currently charge for their usage and add-on services, we can reasonably charge $1,000 per trial per month. To incentivize our partners, we share 10% of revenues with them on a long-term basis to help grow both businesses.

Competitors

We currently know of no other companies with this particular offering. Most EDCs these days have their own eSource and wearables platform, which permit the clinical site to upload documents to the platform and enable crude remote monitoring. But there is little workflow and technical intelligence built into this - most importantly, this represents an additional cost for the clinical site (in terms of increased work) with no benefit, and therefore does nothing to solve the problem of material time lags between data creation (at the time of patient visit) and analysis (when the data is entered into the EDC and available for sponsors / CROs to validate and analyze). 

Traction

We reached out to over 20 EDC companies and had interest from 12 of them. We then chose 2 EDCs whom we thought would be good initial partners as we developed our technology and introduced it in the clinical setting. Our product is fully built out, and we are now preparing to launch on 2 trials (one with each EDC), including a maintenace study with a large oncology CRO and a multi-site study with a university hospital system in Sweden. Finally, we have a strategic partnership with an international European CRO who provided us details about their workflows and the scope of the problem from an operational perspective, and with whom we expect to be launching trials with in Q2 2018.

Due Diligence Docs

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Vikas Vavilala
Co-Founder
Columbia University

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