Delivering the Ultimate Clinical Trial Suite Today
The dramatically increasing costs of clinical trials are under scrutiny. The need to develop more efficient treatments has become the focus of the clinical trials industry. Technology has emerged as an optimal solution amid the ongoing effort to reduce costs. The continued evolution of technology has driven advances in the eClinical solutions market with sustained growth for nearly a decade. During this time, the product offerings of typical eClinical vendors have gone through several distinct phases of development.
Beginning with a broad base of individual, specialized functionalities, many vendors expanded their portfolios through acquisition and subsequent integration of the disparate systems. Increasing demands for clinical trial efficiency are rendering the point solutions of EDC, IRT and CTMS obsolete, and the integrated software suites cumbersome. In order to maximize the potential enabled by eClinical solutions, they must be truly unified.
We now take a moment to paint a clear state of the industry, and to reinforce what should be meant by a unified solution or system. The unified solution Fountayn has offered, from the beginning, is fundamentally different from some of our competitors’ integrated products. The Fountayn Platform empowers users to efficiently design, deliver and manage clinical trials. When we say a ‘unified solution,’ we mean a full suite of products built to work together from the first line of code, in order to reduce inefficiencies and data risk.
Looking Back
Fountayn issued the seminal whitepaper titled, “The EDC Value Proposition to the Pharmaceutical Industry” at a time when EDC vendors were still struggling with a hesitant Pharmaceutical industry.
This study introduced tangible case-by case evidence for the wealth of untapped efficiencies in eClinical technology and issued a call to action. The ensuing period d of rapid innovation and diversification within the emerging eClinical ecosystem would form the base of the platforms we recognize today. It was at this time that Fountayn began talking about the need for an end-to-end unified eClinical platform, and not long thereafter we delivered the first cloud- based eClinical platform on the market. This release also held the distinction of being the first solution on the market that combined EDC and IRT, but more on that later. Leveraging the responsive nature of Cloud Computing and implementing Software as a Service (SaaS) models created the opportunity to transform the IT function across the industry.
Pharmaceutical companies realized however that an unhealthy portion of the efficiency gained through renovation of IT systems was lost with a new problem arising; contracting with disparate vendors. Numerous service contracts were logistically difficult to manage, but more importantly, the proprietary database architectures of these incompatible products fractured clinical data across numerous data silos. To reclaim some of the functionality lost by operating across data silos, companies were forced to integrate these products in-house, resulting in data duplication, migration and new sources of risk.
Dealing with Integrated Solutions
Investing time and resources into a bridge integrating disparate IT systems that handle strongly-related data is wasteful. Pharmaceutical companies seeking to shift the burden of integration had only a few courses of action available:
Wait for widespread adoption of data standards, easing the task of integration.
Contract with eClinical vendors that provide pre-integrated products as an enterprise offering.
Locate a vendor that provided multiple core functionalities.
Adoption of Data Standards
Unfortunately, in any technology industry, the incentive for vendors to push for standards is low. Vendors benefit from the ability to “lock-in” customers by storing their users’ data in proprietary formats. By eliminating the efficiencies of a one-vendor system, standards expose dominant vendors to the threat of competition from innovative products developed by smaller, more agile companies. The upcoming reauthorization of PDUFA V by the FDA promises to lead to the development of clinical data standards and detailed implementation guides of 2017. As a more agile company, Fountayn has embraced open data standards and the challenge to innovate that comes with it. To date, we are compliant with seven CDISC standards and implementations.
Outsourced Integration
With standards not yet established, contracting with multiple eClinical vendors to provide pre-integrated products emerged as the most popular choice. As the industry began embracing the option to outsource integration, many single-product eClinical vendors began the process of acquiring products to complement their existing offerings. Among the most notable is Oracle’s acquisition of Phase Forward, Perceptive’s acquisition of ClinPhone and Medidata’s acquisition of Clinical Force. While acquisitions provided the benefit of a one-stop shop for clinical IT, it can also come with the issues of product integration, as the products built or acquired were not developed, from the beginning, to work together; many can still have data silos that require migration and manipulation of data. Migration and manipulation of data does not represent a ‘unified solution,’ even if sold under the umbrella of a single vendor’s brand.
The Fountayn Platform does not require data migrations, as, from the first line of code, all our individual solutions have been built to work together without the migration and manipulation of data.
The Cost of Integration - Buyer Beware
The technology “bridge” that integrates disparate systems must be built, and if it is built by the eClinical vendor, this will be reflected in its pricing scheme. But construction is just the beginning; it requires steady maintenance to ensure functionality remains as other changes are made. This can silently affect the cost of any development effort that touches integrated parts.
Enhancements and bug fixes can often change the underlying data models or the manner in which they are accessed. When this happens, the bridge that integrates the disparate systems must also be updated. In an integrated eClinical platform, this is often reflected in the difficulty, downtime and associated costs of providing bug fixes, enhancements and completing change orders. The complications created by maintaining this bridge between products not internally developed from the ground up can be worked around so the consumer may not have to deal with the headache themselves, but they likely pay for it.
Integrated systems can suffer a blow to both efficiency and reliability. Often data transformations are performed using expensive extract-transform-load (ETL) procedures, to convert data pulled from one system into a format recognizable to another. In an eClinical suite, data may need to migrate between modules quite frequently, requiring data manipulation every step of the way. More importantly, every time data is transformed, it is exposed to the risk of corruption. Errors do occur, and the more moving parts that exist, the greater the risk. The migration and manipulation of data can make validation operations even more crucial, frequent and expensive in an integrated platform.
Data migration is commonly required by eClinical vendors that deliver integrated solutions when performing system upgrades, bug-fixes, or mid-study changes and Protocol Amendments. This is a costly procedure both in fees and system downtime, more so if errors are found during validation. A study conducted by IBM found that, while migrations are routine, 83% experienced problems, with system downtime cited as the leading problem. The additional costs of these migrations are dependent on each trial; however, the impact doesn’t end there. The FDA presented findings that 43% of their review time is focused on data migrations. Eliminating data migrations in the clinical trial process can dramatically reduce the review process.
Product development can be greatly limited with integrated solutions. Because the disparate systems are not built to work together, a change in one system requires additional time and investment in all other systems that are touched, driving R&D costs and timelines up. Difficulties such as these are the reason your current vendor may offer Single Sign-On functionality as a separate product rather than a feature of its platform. This functionality is itself likely an integration of disparate login systems and the costly design effort to build it is the reason it isn’t offered for free.
Not all such enhancements are as simple as the single sign-on. Over time, these limitations can add up to a significant gap of product innovation that is simply notpossible on an integrated software platform.In the rapidly changing landscape of clinical trials, limiting a solution’s ability to respond and adapt to change can have difficult and unpredictable consequences for both the vendor and the user. The problem facing many eClinical vendors is one of a rapidly expanding perception of what the “core functionalities” of their platforms should be, and the shrinking space of what is acceptable as a solution.
The Fountayn Platform requires no data migrations, so enhancements are focused on delivering an ever-better product. Bug fixes are easily implemented with no downtime. With no data migration or manipulation, potential errors are not only avoided, but valuable time is saved. Our R&D expenditures support real product improvements unencumbered by the complexity of data silos and resultant migrations. Because our product is built as one unified solution, the only option is a single sign-on.
Multiple Core Functionalities
Identifying a vendor that offers a full suite of products, built to work together under a unified structure eliminates the complexity and risk of integrated solutions and their data silos. Ideally, cloud-based service models should reduce silos by delivering purpose-built, end-to-end infrastructures as a utility. In order to realize this benefit, the infrastructure, the basic foundation of the system, must be part of a unified solution.
Defining Unified & Benefits
‘Unified’ software products are not coaxed into working together, but are built for each other. They utilize the same system for managing data so all clinical data can be sourced across a variety of eClinical applications. This unified architecture makes data migration obsolete, delivering higher efficiency, reducing risk and providing better quality data, not to mention a shorter review time by the FDA.
Fountayn delivers a unified eClinical solution that obviates data migration, mid-study change downtime, or data synchronization across systems, in our unified platform, all data is available across all solutions, around the globe immediately in real time.
If your vendor performs data migration, you are not using a unified platform. Unified solutions are built on the same system architecture in which data silos are rendered nonexistent. Unified solutions feature a common interface, meaning no matter what product users might be applying, the tools at their disposal all have a similar approach and process. This keeps training simple, and it reduces timelines and related costs. Unified solutions deliver a seamless eClinical experience.
Unified products are far more flexible in the application of innovation. Simplified and open communication channels between unified products allow developers to build upon them without risk of breaking ‘fixes’ in the effort. Unified systems free the developer to focus on new features that harness higher quality data, target the needs of clinical trials, the people that run them and the patients who participate in them, without the complexity of addressing technology bridges.
Fountayn’s data platform is fundamentally different from all the other purportedly “unified” products that have cropped up in the last year. In many cases, these vendors are simply misusing the term.
Putting the Right Foot Forward
Fountayn by contrast, foresaw the need for a unified platform and built each product with the assumption that these were simply parts of the greater whole. Today, the Fountayn Platform offers a full suite of products, which can be utilized individually, in pairs, in groups or as a whole without complication. Think about the seven products as light switches; you can simply turn them off or on and they will work seamlessly together because they are all part of a unified solution.
Because each of these products was designed as part of a unified whole, they are specifically crafted to take advantage of this relationship in ways that products that have been integrated (or advertised as “unified”) as an afterthought, cannot.
*Fountayn Formerly Known as Datatrak