As we move into a new decade, one thing remains very clear – technology, medical science and healthcare are advancing at a dizzying pace. When coupled with new sources of data, increasingly complex study designs and new insights from analytic sources, clinical trials are also evolving more rapidly than ever. Sponsors and CROs need technology solutions to maintain the same rapid pace of change to support new requirements. At the same time, they must effectively manage the data and maintain compliance under highly scrutinized budgets and tight timelines.
These dynamics are demanding a new mindset toward clinical trials, including how teams build and manage studies to collect and clean data, while delivering successful clinical trial results as efficiently as possible. This shifting mindset focuses on enabling expertise with practical capabilities to streamline data collection, analysis and reporting while also providing the flexibility to adjust to changing requirements. As sponsors and CROs try to get the most from their eClinical solutions, there are four priorities to consider when selecting an eClinical technology that have clearly emerged as defining factors for success.
Today’s eClinical buyers demand technology solutions that address these priorities simultaneously. All four are equally important. The combination of functionality, flexibility, simplicity and affordability determines how efficient, scalable, and proactive clinical trial teams can be in the face of increasingly complex and dynamic clinical trial requirements. It also dictates the degree that clinical trial teams can enable their expertise and apply creativity to study design activities. The delicate balance of these four factors in an eClinical solution can help researchers maximize technology to enable expertise and flexibility throughout the entire clinical trial process.
Whether you are a CRO or a sponsor, you shouldn’t have to face the false dilemma of choosing between flexibility and simplicity or affordability and functionality. For example, a simple user interface that doesn’t extend across multiple users and tasks has limited benefit. Every time a data manager is required to hand over a task to a programmer, the interaction has the potential to be a bottleneck or a detour that can derail the project and add to time and costs. This quickly eats up any efficiencies gained by a simple user interface design.
A high degree of functionality can be found in broad unified platforms built with native applications. These platforms provide greater functionality without the increase in complexity that is seen in complex eClinical suites that may rely on integrated systems that don’s inherently ‘talk to one another’. A unified platform with native application enables configuration as a preferred alternative to customization. In addition, preventive functionality such as real-time edit checks reduce work and implementation of this type of business logic results in better data quality across the system. At the same time, auto-generation of human-readable “intents” for business logic shorten validation times and replace manual creation and validation which traditionally took time and were error-prone.
A platform that enables you to extend capabilities to support key roles can also have additional positive impacts. For example, medical monitors are very busy and are also very expensive resources. Providing a solution that enables easy access to clinical trial documents for them to review and sign, sponsors can save time and money.
Today’s buyers also need solutions that easily adapt to the evolving – any varying – nature of clinical studies. It means that users can easily adjust to the increasing complexity of study protocols, varying requirements and mid-study changes. A flexible platform scope also supports more roles and provides greater resourcing flexibility within sponsor and site teams. Research coordinators need to see and act on incomplete record reports. Monitors can view ongoing data capture and investigators need to be able to sign off on data. Dynamic reports that link users to underlying records facilitate issue resolution and dashboards and alerts support team communications.
The dynamic nature of clinical trials continues to shape the eClinical marketplace. A new mindset that prioritizes functionality, flexibility, simplicity and affordability has helped to distinguish the unified platform as the ideal eClinical technology choice for the majority of clinical trials. A unified platform built from the ground-up with native modules combines the simplicity of a point solution, the robust functionality of a complex eClinical suite and the required flexibility to support changing clinical trial requirements in one affordable, comprehensive package. Solutions that address these critical needs and also adapt to accommodate the evolving nature of clinical trials will deliver dividends now and in the future.