Mission IR - Priming the PUMP
DATATRAK International, Inc. (DTRK) Unified E-Clinical Solutions Platform Key to Improved Efficiency, Reduced Cost in Clinical Trials
Posted on March 6, 2015 by MissionIR
Transparency Market Research’s October 2014 report on the clinical trial management system (CTMS) market indicates that the global CTMS space alone, worth just $844 million in 2013, is on track to grow at a 14% CAGR through 2019, when it will hit around $1.85 billion. CTMS software platforms are used to manage, store and analyze the huge volumes of clinical data associated with a given drug/device and to circumspectly execute the requisite planning, preparation, and reporting to carry out a clinical trial. Another report by Transparency Market Research, also out in 2014, focused on the broader e-clinical solution software market, which encompasses licensed enterprise, web-based and cloud-based deployments spanning the CTMS, as well as clinical data management, electronic clinical outcome assessment, randomization, trial supply management and safety solution markets. That report indicates a similarly robust outlook for the industry, with a projected CAGR of 13.8% through 2020, as the market swells from around $3 billion last year, to over $6.5 billion.
Growing pressure on the pharmaceutical industry to shave time off the clinical trial process and simultaneously increase drug productivity, as well as the rapid emergence of e-clinical solution users like healthcare providers and contract research organizations (CROs), have created serious tailwinds for the e-clinical solutions software market. Moreover, the growing cost to take a drug from conception through to FDA/EMA (or other relevant agency) marketing approval, has steadily increased over the years and major e-clinical solutions sector player Oracle (NYSE:ORCL) has documented the associated decline of U.S. and Europe in terms of their percentage share of the global clinical trials market.
Japan, China and India have all seen notable increases over the same interval, due in large part to improved regulatory and patent expiration laws in Asia, as well as lower overall clinical trial costs compared to the U.S. and Europe. Hence the massive demand, particularly in western markets, for comprehensive e-clinical solutions that can help cut time and money off the clinical trial process, as well as the associated rise of CROs, to whom developers can outsource their R&D work. The CRO market size alone was around $23.6 billion in 2014 according to Industry Standard Research Reports, where growth has been driven mostly by increasing R&D budgets ($245.7 billion in total) among biotech, specialty, and generics companies, in addition to the demand for cost-effective clinical trial outsourcing among new drug/device developers.
These market conditions have created a huge boon for companies like DATATRAK (OTCQX: DTRK), which serves the global clinical trials industry with their comprehensive, unified e-clinical solutions platform and related services. The company’s DATATRAK ONE® unified platform provides a single data source architecture that powers all of DTRK’s e-clinical solutions, brilliantly eliminating the often cumbersome and time consuming process of data integration. Built for the cloud, this architecture, complete with a superbly intuitive and easy-to-use interface, even allows for rapid mid-study changes to be made on the fly, while also maintaining rock-solid uptime.
Because the DATATRAK ONE architecture is a component-based platform of independent solutions which are designed to integrate seamlessly in any configuration, no matter what the specific deployment looks like, developers have full-spectrum control over all aspects of a given clinical study, with real-time access to all their clinical data. The DATATRAK ONE Unified Experience™ approach confers numerous benefits in addition to industry-leading system reliability, intuitive design and a unified data source, like improved site compliance, higher granularity in the data sets, reduced trial complexity, and accelerated, cheaper trialing, with a dramatic improvement in overall trial safety being a natural bonus. Moreover, the DATATRAK Clinical Consulting Services (DCCS) team brings the kind of trial type and phase spanning expertise needed for developers to run a truly successful trial. With the DCCS team becoming an actual extension of the development team and utilizing the same customer-centric approach that has already made DTRK a preferred provider with partners all over the globe, DTRK provides the software and the services developers need to compete and thrive in today’s highly competitive clinical trial market.
The DATATRAK ONE architecture does it all: planning and management using the UX CTMS™ component; design and deployment in one tool with the UX Trial Design™ component; data capture and delivery with the UX EDC & Medical Coding™ component; randomized patients and automated supply with the UX Randomization & Trial Supply Management™ component; patient-driven data collection with the UX Patient Data Capture™ component; individual case safety report management with the UX Safety™ component; and robust user training, as well as certificate tracking with the UX Training™ component. This unified architecture also offers unprecedented capacity to be fully configured to the individual user’s specifications and is accessible via single sign-on, delivering a vastly improved user experience and the company genuinely considers its users to be partners as well, providing a wealth of expansion programs that can help forge an even closer bond under the DATATRAK CONNECT® banner.
The company has a CRO-focused partner program, which supports CROs via a collaborative effort that translates into further time and cost savings benefits, complete with co-marketing opportunities and access to the DATATRAK sandbox, as well as demo and bid defense support. The company also offers a technology partner program focused on granting tech providers an interoperable channel via access to the DATATRAK Exchange API (application programming interface), which enhances overall usability and understanding for tech providers of the architecture and its solutions, while simultaneously introducing them to potential clients who are already keen on the significant benefits of the platform. DATATRAK also does a highly unique reseller agreement program with strategic partners in adjacent industries where their architecture has yet to achieve a sizeable presence, like with China/Japan-focused NTT Data. This is a particularly lucrative vector for DTRK given the outlook for the Asian e-clinical solutions market and shows how spry the company can be when it comes to penetrating new markets.
The recent expansion in February of multi-year global enterprise agreements with three top CRO enterprise partners, who have opted to extend their relationship with DTRK and increase their global licensing capacity, is abundant proof of how the advanced DATATRAK platform is actively reshaping industry expectations. Cumbersome complexities like data integration, once considered unavoidable by most developers, vanish within the DATATRAK ONE architecture and innovations once thought impossible, like cross-study real-time data reporting, are already fully integrated features of the platform. In addition to the recently added cross-study manager, which provides tailored information support to each individual researcher, granting extremely flexible reporting across 100 plus fields, DTRK has added an automated information delivery scheduler, as well as collaboration-facilitating file versioning, to their full suite of enterprise-wide online data management tools.
Whether clinical trialing is outsourced work being done at a CRO, or in-house pharma/biotech or device development, DATATRAK prides itself on removing the most difficult to contend with complexities and delivering truly revolutionary advantages to the development process. This is particularly apparent with the platform’s ability to do aforementioned mid-study changes in the field of biopharma development, where the complex work never needs to come to a halt in order to integrate new changes, an advantage which translates directly into improved development cycle times and cost efficiencies. The advantages of the DATATRAK architecture are also readily apparent in the device development field, where the dynamic regulatory landscape presents unique challenges that can be ably surmounted by DTRK’s fusion of proven technologies and industry expertise, whether the specific goal is clinical trial data collection for pre-market authorization approval, or keeping tabs on product usage once the device has gone live.
Fully aligned services to support their unified technology platform rounds out the equation at DATATRAK. With an experienced arsenal of development teams, project managers and trial designers at their disposal, as well as a complete solution center and technology services under the DCCS umbrella, DTRK is a one-stop-shop for clinical trial industry developers looking to up their game. The company provides thorough training programs that are recognized throughout the industry as being top notch, thanks in large part to the company’s extremely knowledgeable learning solution specialists and the wide variety of hands-on training that is available to meet any client’s needs.
Diving deeper into the company’s services, we see that DATATRAK’s solution center is a highly personalized single source contact which goes above and beyond the traditional definitions of a help desk, providing customized, proactive help that dovetails exceptionally well with the company’s learning center, which is comprised of a knowledgebase covering every area of the e-clinical world. DATATRAK’s experienced team of clinical data managers also help support the company’s clients with full-service assistance, ranging from initial study builds through to database closeout, and the company has a wealth of experience in trial design as well, enabling clients to take the guess work out of preparing and executing across the vast landscape of therapeutic areas and trial Phases.
Get a closer look at DATATRAK by visiting www.Datatrak.com
