The COPCOV clinical trial represents (at least when it was launched) the largest COVID-19 focused interventional clinical trial in the world. The randomized prophylaxis study led by University of Oxford-supported Mahidol Oxford Tropical Medicine Research Unit (MORU) in Bangkok, Thailand, involves the recruitment of up to 40,000 frontline healthcare workers and associated team members around the world with a heavy concentration in Asia. Toronto-based Axiom Real-Time Metrics (“Axiom”), an “eClinical” software vendor, announced they were selected to support this prestigious clinical trial. Apparently, Oxford is sold on the vendor’s eClinical suite known as “Fusion,” which includes an integrated bundle of clinical trials management tools, including Electronic Data Collection (EDC), electronic Patient Reported Outcomes (ePRO), and Randomization and Reporting functions. This is a strategic win for Axiom, which competes in an incredibly competitive space with aggressive software and “cloud” based companies.
COPCOV represents an incredibly important interventional study led by one of the world’s elite academic clinical research sponsors. With massive scale under an incredibly pressure-driven pandemic environment, that a relatively unknown Canadian vendor was selected is a testimony clearly to their product quality. After all a vendor must be able to deliver in a study with up to 40,000 patients and 100 sites distributed worldwide.
Impressive Configuration Speed
Often so-called enterprise software sold into large pharmaceutical sponsors takes quite an effort to set up and configure the system for use. It is not unusual to hear about electronic data capture or IXRS (subject and investigational product randomization) deployments to take significant time. Naomi Waithira, Head of Data Management at Mahidol Oxford Research Unit, University of Oxford, first acknowledged the great experience working with this vendor and reported that the integrated product was configured “in just a few weeks.” TrialSite News can assure those in the TrialSite Network interested in clinical trials technology that this deployment speed combined with a still happy customer is a notable data point.
The best vendors partner with their clients to form a value-added, win-win relationship that can endure over years. Andrew Schachter is the founder and CEO of Axiom and commented in their recent press release, “We are honored that the University of Oxford and its collaborators have placed trust in Axiom with respect to the criticality of the real-time capture of clinical daily patient reported outcomes to this study and the management of its trial data.” The CEO shared that it was a matter of pride that his company not only won this deal but has been a partner in the delivery of the solution.
Emerging as a Company to Consider
Axiom, founded back in 2001, has been a consistent player in the eClincial market but has it was based in Toronto and didn’t raise outside capital; it wasn’t that well known in the large American market to the same level as Oracle, Medidata (Dassualt) or Veeva for that matter. But the company spent years developing and refining an integrated suite of clinical trials technology tools that now total over 15 modules. Then in 2019, a pharma-savvy private equity group called Great Point Partners bought into the venture and now the Canadian company has major funding backing its growth moves.
Their unified, intuitive suite (Fusion) of products include the following: electronic data capture (EDC), data management (DM), integrated web response technology (IWRS), clinical trial management system (CTMS), inventory management, integrated voice response (IVR), Patient Portal, adverse event/serious adverse event (SAE) tracking, safety data base, central lab imaging, eTMF and 24/7 project and clinical data reporting. Now with a financial partner/shareholder with approximately $1.5 billion under management, the company could start positioning and marketing itself to clash with the larger competitors.
With an estimated $150 to 200 employees, the privately held firm reported in 2019 that the company grew 5,000% and team growth of 900% since 2010. In 2019, it opened a new state-of-the-art facility with 30,000 square feet in Toronto. The company shares it has 10,000 sites that have used the system representing 650 completed studies.
The Importance of Data Management in Clinical Trials
The ultimate currency of the clinical trial is high quality data generated, collected, managed and reported on during the clinical trial. This data will make its way into reporting and if successful regulatory submissions for regulatory authority market authorization. Clinical trials can be long, complex and expensive affair with inherent risk for delays and failure. An individual study can range from simple and straightforward studies in the hundreds of thousands to over one hundred million. Hence the data management represents a vital underlying services and activity in clinical research. If the data management solutions seamlessly integrate with all of the data collection nodes and endpoints, the net result can be a dramatic reduction in time from clinical development to approval and hence marketing. With high cost drugs costing north of $2.6 billion, the famous metric is that one day’s delay represents a lot of capital. Getting all of this right is of critical importance.