Special Report on the China Pharmaceuticals 2018
Global Business Reports
Interview Transcript of Jim Bob Ward, President and CEO – Datatrak International
Can you briefly introduce Datatrak’s company history and how its core service offering applies to the pharmaceutical industry?
The Datatrak Enterprise Cloud provides real-time business intelligence and oversight to data that our clinical research platform captures and manages from sites, patients and devices in multiple languages throughout the world. It’s all about ease of use. We provide a single point of access to all your clinical data from one unified database source depending on your roles and permissions. The initial value to our clients comes from products designed to accelerate reporting to sponsors and ultimately regulatory authorities at lower costs. The value-add comes from the analysis of your Big Data collected across pre-clinical, Phase I – Phase IV drug, device and diagnostic studies for ongoing product development.
Datatrak created the Electronic Data Capture (EDC) market in the late 90s. This product was cutting edge at the time, but by 2006 it was becoming obsolete. As a result, Datatrak acquired my company ClickFind, which created what is believed to be the first cloud-based clinical research platform. Our approach has been to consistently offer the latest and greatest versions of a unified system to reduce the cost and risk associated with integrating disparate systems as the industry migrates to the cloud.
Moving forward, Datatrak is focused on delivering client operational efficiencies through the next generation of technologies, which empower people to work remotely, from the office, while traveling or at home, as cloud-based teams in a global world. Teams that can be configured with the clinical and business tools necessary to represent the client’s corporate hierarchy with business process workflows and regulatory policies and procedures needed to operate as a cloud-based enterprise.
This is not a new initiative, our enterprise model was originally created with systems like Google, Salesforce, and Amazon in mind as the ultimate solution for enabling subject matter experts to conduct day-to-day business within a collaborative content-driven model. Technology changes, population growth and the resulting demand for big data analytics have irrevocably changed the role of the pharma and medical device industries. Our strength and scalability tests on the platform were highly successful and surprisingly viral, positioning the Enterprise Cloud as the next natural step to supporting clinical research and life sciences market growth.
Can you elaborate further on how your software solutions assist pharmaceutical companies in being more efficient?
IBM states that 90% of the world’s electronic data has been created in the last two years. The tsunami of data impacting the clinical research industry is so intense that its disturbing. Naturally our operating efficiencies enable us to offer solutions at half the price of our global competitors. That alone is no longer sufficient. As innovators, we have adopted the leading Sisense business intelligence platform and integrated their dashboards, data visualization, predictive analytics and more into our platform, Clinical Trial Management and Electronic Data Capture products as standard or client white-labeled offerings. Both solutions help clients identify new product and protocol opportunities while saving significant infrastructure investments.
What are the key challenges the pharmaceutical industry faces when it comes to incorporating data-driven solutions into their business models?
Investors and shareholders expect sponsors to use best practices to create opportunities from Big Data. However, the overwhelming and increasing amount of machine generated data from CTMS, EDC, EMR, core lab, images, clinical devices, patient wearables, and third-party data require new storage and analytical capabilities that may go beyond their internal expertise and budget. The cost and risk increases exponentially when faced with changing country and agency regulatory responsibilities affecting the security, access and ownership oversight of Big Data.
There are several challenges that go beyond the decision to invest and bring solutions in-house or partner in a Software as a Service model. Business Intelligence is primarily based on predictive analytics which is either based on scientific research or artificial intelligence. Both require capabilities that are not always readily available or inexpensive. The scientific research approach involves fewer numbers of trained statisticians who can identify solutions faster than AI. Unfortunately they are limited to what they don’t know. The AI approach involves large numbers of developers who can identify solutions slower than research scientists. However they can find solutions not limited by conventional science. The ultimate solution is to use both methods in a Big Data strategy.
Datatrak has been involved in 21 studies across 19 different CROs and company sponsors within China. What is your strategy for expanding further into the China market?
Our expertise is empowering partners with our technology. Our product line can be accessed in any language and meets the requirements of any of the countries where we operate. We have a strong partnership with NTT Data. They are a well-known entity in Asia and a trusted powerhouse in Japan where have reached the number two position. Our partnership with NTTD allows us to establish a presence in China, which includes IT infrastructure, over 2,000 employees with Chinese representatives to provide sales, training, support, infrastructure, and project management. Privacy, ethics and oversight remain top concerns for our clients in China, who are looking for high quality, standardized software to protect the quality of the products and privacy of patients.
What is your final message to our readership about the capabilities of Datatrak’s software solutions and your outlook on the necessity of integrating technology into a successful pharmaceutical business model?
We are a secure and trusted provider of global clinical research solutions with over 25 years of experience. Our Cloud Enterprise platform is scalable from the basic early stage trial to the most complex global trials. Our CTMS is unique in that it will import trials from competing EDC vendors that can be measured with our business intelligence dashboard. Datatrak is expanding into the Chinese market with an interest in creating long-term relationships. Relationships based on empowering clients to scale our technologies to their budgets and timelines that provide optimal return to investment.