February 13, 2014 -- Dramatically increasing costs of clinical trials have resulted in a search to optimize the industry. Rooting out inefficiency wherever possible, advances in the evolving market of eClinical solutions have seen sustained growth for nearly a decade.
Beginning with a broad base of individual, specialized functionalities, many vendors swiftly expanded their portfolios through acquisition and integration. With ramped up regulatory pressures, increased 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, products must be truly Unified.
Our industry is facing the next phase of technology for clinical trials, and the choices being made today will have a systemic impact on clinical productivity for years to come. Unfortunately, the eClinical solutions space is in the midst of a misleading code switch from “integrated” to “unified”.
The Unified future DATATRAK has offered from the beginning is fundamentally different from that being offered by our competitors.
Integrated Products
Integrated products are the compilation of separate, distinct systems not created to work together. Integrated platforms require additional code development to create a link between the individual systems. The bridge must be built, and if it is built by the eClinical vendor this will be reflected in their pricing scheme. Construction is not the only price of a bridge; it requires steady maintenance. This silently affects the cost of any development effort that touches integrated parts. Enhancements and bug fixes often change the underlying data models or how they are accessed; the integration that translates these disparate systems must be updated accordingly. In an integrated eClinical platform, this is reflected in the difficulty, downtime and costs of providing bug fixes, enhancements and completing change orders. All are complicated by maintaining this bridge between products not internally developed from the ground up, and while the consumer may not have to deal with the headache themselves, they certainly pay for it.
Integrated systems 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 move between modules quite frequently, incurring these penalties to performance every step of the way. More importantly, every time data is transformed, it is exposed to the risk of corruption. The movement of data makes validation operations crucial, frequent and expensive in an integrated platform. IBM estimates that an alarming 8-12% of the total cost of clinical trials is simply moving data between disparate systems.
Unified Product
Unification is the concept that software products are not coaxed into playing nicely together, they are built for each other. They utilize the same system for representing data so all of a client’s clinical data can be housed in a single database. Properly executing this architecture completely obsoletes the practice of data migration.
Data and database migration is required to move data from one access point to another. This is a costly procedure in terms of both fees and system downtime while the data is being moved, 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 cost and inconvenience of data migration has led prominent vendors like Medidata into such bizarre business practices as providing bug fixes only when explicitly requested by a client. This outdated procedure is now the accepted norm in clinical trials because a majority of eClinical vendors present it as a simple matter of course. If your vendor performs data migration, you are not using a Unified platform.
Unified solutions are built on the same system architecture; by operating on a single database, data silos are rendered nonexistent. They should feature a common interface, meaning no matter what product a user might be operating in, the tools at their disposal all have a familiar appearance and layout. This keeps training simple, and it reduces timelines and related costs. Unification delivers a seamless eClinical experience.
Unification is, for DATATRAK, not a feature, but a design philosophy. Our efficiencies of design and levels of reliability cannot be replicated by competitors because the choice to build a Unified system has to be made from Day 1. IT has introduced powerful change to the industry, but this does not stop at the point solutions of EDC, IRT or CTMS. The new reality is that a single end-to-end system, a Unified system, is needed to keep this giant engine running at full steam. The Unified DATATRAK ONE CLINICAL ERP™ is the only purpose-built system. Period. This is the Unified future available Today.
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