Paperless Platforms

In an emerging paperless clinical development environment, it has never been more important for companies to develop a set of standard technology and process platforms, use them effectively in order to integrate pockets of information throughout the enterprise, and scale up new advanced technologies or integrate existing systems. Combinations of tools are used in an eClinical enterprise, some of which are study specific, such as EDC and IVR/IWRS, and others are used to record and report across many studies, such as clinical trial management systems (CTMS), business intelligence platforms, analysis, safety and submission systems. Within any given project, there is an order of events, from capturing regulatory information, site and patient recruitment, enrollment, treatment, managing visit status’ and queries, event reporting, study lock and ultimately, submission. This data is managed by any combination of the technological systems already mentioned.

When platform independent standards exist, such as CDISC’s operation data model (ODM) defining the eCRF and lab data, information can be passed from source to target systems with confidence. These standards enable an eClinical enterprise that supports the use of complete platforms, as well as the ability to interchange components over time, for vendor preferences or best-of-class tools, as technology continues to improve. The standard data models provided by CDISC already provide a comprehensive platform, which will be further enhanced by emerging logistical data models. Use of conventions, such as CDISC models, coupled with standard integration processes, not only enables significant improvements in overall efficiency and trial scaleability, but also addresses continuous industry changes.

Standard integration processes are also a key element when attempting to solve the integration puzzle, whilst providing additional efficiencies. It is not enough to simply have software compatibility. In an environment where clinical trial technologies are interchangeable, and data conventions become accepted, standardised data processes will ensure that there is little variation as personnel, tools and vendors change. Defining best practices in this area will ensure a path for the future.

INDUSTRY CHANGES

There are many changes in life sciences that must be constantly addressed by sponsors, service providers, software vendors and regulatory agencies in order to support and improve the clinical trial process. Some examples are provided in the following.