Drug developers today must choose among a myriad of clinical software solutions. Cloud-based solutions, offering improved data exchange, are picking up as data safety concerns abate. However, the more technology solutions that become available, the more they contribute to layering and underlying challenges through numerous disparate clinical trial systems. The latest solutions focus on improved access to all data, regardless of the systems in use.
Clinical software provider PharmaPros has just launched its eClinical Intelligence platform, which leverages cloud computing to acquire data from any source system in real time. The company has also changed its name to eClinical Insights to reflect its core business transition from a technology-enabled services organization to a SaaS-based software firm.
So, what are some of the latest technology trends and what areas can we expect clinical software products to focus on in the future? Brion Regan, head of Strategic Development, eClinical Insights discusses the business transition and the future of clinical software.
Contract Pharma: What was the thinking behind the company's name change?
Brion Regan: PharmaPros has been in business since 1996 and has evolved over the years. The company's initial business model focused on implementing and integrating large scale clinical systems for Big Pharma, and has since evolved into a niche services organization delivering technology-enabled clinical trials management services for mid-sized BioPharma and Medical Device companies.
The company's most recent business transition began in 2009 with the launch of our first Software-as-a-Service (SaaS) product, Dataflow Manager. Since then, we've developed a suite of SaaS products, all built on our cloud-based integration and analytics platform. As such, the name change is more reflective of this transition to a SaaS-based software firm, and speaks to the core of what we provide.
CP: What current obstacles do you look to overcome in the clinical data realm? Also, what areas have seen major transformation?
BR: Over the past 20 years, our industry has made significant advancements in the area of electronic data capture. While this innovation has delivered significant improvements in how clinical trials data is captured and stored, it has also contributed to one of the critical business challenges the industry faces today, which is how to turn these disparate electronic data sources into integrated and actionable information.
Rather than build a “big-data” repository, or suite of data capture systems, or yet another ad-hoc reporting tool, eClinical Insights has chosen to focus on improving the business of clinical trials management by delivering integrated workflow applications that are driven by real-time data through the cloud.
CP: How did you achieve that?
BR: We invested heavily in our data sharing and integration capabilities. We can confidently say that we've integrated with more eClinical technologies (in a scalable and repeatable way), than other companies in our industry. The custom integrations, VPNs, and ETL tools the industry has traditionally leveraged to share data are not a scalable or cost-effective answer for the future. Instead we focused on building out-of-the-box web-services interfaces to the industry’s leading EDC products, along with developing a framework that allows us to integrate with any database technology via web-services. Solving this challenge has enabled us to build products on a single web-based platform, which our customers could use alongside their existing systems.
While we have had great success in integrating data from disparate sources and products, there is still work to be done across the industry. Many data-capture vendors have not yet addressed outbound data sharing, and are still in the early stages of developing commercially available web-services APIs [application programming interface] to enable streamlined data sharing with third-party applications.
CP: Have security concerns regarding cloud platforms subsided?
BR: With the adoption of EDC over the past decade, clinical research data is increasingly being collected remotely at third-party data centers. As a result, the clinical research industry has made progress with remote data storage and new boundaries have been forged surrounding data access in general. The responsibilities, controls, and security management provided by third-party data centers and system administrators have delivered significant improvements compared to when data were all centrally managed and stored in-house. This evolution has ultimately served as groundwork of the broader movement toward cloud technologies.
CP: How are these concerns addressed?
BR: Concerns regarding access to clinical data in the cloud can be addressed by developing technologies that meet clinical research requirements, and by thorough testing. For example, with our clinical data hub, Adapt Central, data is integrated transactionally from source capture systems to enable complete traceability and auditing of the original clinical data record. This enables us to address data governance concerns, and ensure compliance with regulations for clinical research, such as FDA 21 CFR Part 11. Also, system testing, documented requirements and results, along with quality development practices that are auditable by third parties, are essential.
CP: Do you see more companies utilizing cloud platforms or moving research networks there?
BR: What we are finding is that there are several fit-for-purpose clouds. Depending on the need, various types of cloud applications exist, from public to private, and interdepartmental clouds. eClinical Insights is working to build a cloud fit for clinical research, and we have dedicated significant efforts to ensure that our cloud meets the requirements and regulations for clinical research in order to allay potential concerns. All security requirements that have been established by the FDA can be achieved in a cloud-computing model. It's more a matter of shifting the paradigm of clinical data management practices.
CP: What are the challenges surrounding externalized networks?
BR: This technology is still emerging, and there’s a lot of work that needs to be done by all third-party technology providers to build better interfaces for data interchange. Few organizations use one vendor for all of their technology needs. As such, the ability to build interfaces between third-party systems is critical to enabling a more integrated approach to managing and leveraging clinical research data for new innovations.
CP: How does the new eClinical Intelligence platform work?
BR: With a proprietary data integration framework, cloud-based eClinical data hub, and a business analytics engine, all serving as the core of the platform, our products can interface with any clinical technology a customer is using, and deliver on the mission-critical intelligence that resides in their data, with no disruption to their underlying systems.
Customers can subscribe to one or more of our products, which are oriented toward specific functional areas such as data management and clinical operations, through one integrated platform. Each of the products leverages a common architecture and are all driven by real-time data.
With the ability to integrate with any system a customer is using, our applications can be layered on top or alongside other systems, to provide integrated workflow across their clinical trials operations. From trial performance analytics and dashboards to clinical endpoint adjudication, our focus is on delivering visibility and control across the disparate systems and diverse teams being used to conduct clinical trials across the globe, and enabling trial sponsors and their CROs to collaborate more effectively.
CP: What are some of the latest technology trends and what areas can we expect products to focus on in the near future?
BR: One interesting trend is the transition away from the traditional clinical trials management systems (CTMS) of the past. These were typically repurposed CRM systems implemented behind the customer firewall, and could serve as a jack-of-all-trades for managing trial information and documents.
What we're now seeing is the emergence of technologies that focus on one functional area that would fall under the big umbrella of CTMS, such as site payments, or document management, and do it really well. These new technologies are available in the cloud, and have been developed from the ground-up to support clinical trials management.
This trend is also disruptive for an industry that has been slow to adopt change. While these companies are innovating and automating manual processes, they are also contributing to the continued proliferation of clinical trials systems.
While there may be an urge to physically centralize all this information, this trend will ultimately make it easier to put the pieces of the puzzle back together to form a holistic picture. The reason why is that they are built to interoperate with other technologies via web-services. Much like we experience on Amazon or online banking websites, the future of technology is this amalgamation of tools that combined, deliver better visibility and control.
We see this trend as an opportunity to effect positive change through better information-sharing and process automation. Our goal is to integrate these best-of-breed technologies through our eClinical Intelligence platform and provide our customers with enhanced capabilities across their eClinical enterprise. With the industry's recent focus on risk-based strategies for site monitoring, and consortium collaborations such as TransCelerate BioPharma, clinical technology solutions that share this collaborative spirit will be necessary to fully realizing, and scaling these initiatives.