The current approach to clinical trials scientific data management struggles to keep pace with the challenges of faster time to market and the increasing complexity of global studies. Fragmented data sources force users to spend more time searching for and aggregating data to make decisions.
According to a 2013 ISR reports1 study, most pharmaceutical companies and CROs recognize the burden of using multiple data collection and trial technologies. There is a trend toward using more tightly integrated systems that house functionality found in current EDC, ePRO, CTMS and Interactive Voice Response (IVR)—also known as Randomization and Trial Supply Management (RTSM) systems—but only 50% of those surveyed had experience with these systems.
The benefits of integrated eClinical solutions
Integrating a clinical trial’s scientific and operational data can decrease the time users spend searching for data, simplify the complex and accelerate time to market by facilitating and improving decision making. eClinical solutions offer these benefits by integrating multiple data streams and simplifying the entire clinical trials process, from study design and data collection to database lock and reporting. eClinical solutions offer the ability to review historic data on site performance, protocol quality, subject recruitment and drug accountability to inform and improve planning for future studies.
To simplify data collection, review and analysis, and incorporation into company processes, an eClinical solution should streamline data integration and accelerate clinical development by:
- Enabling users to work in a unified environment
- Integrating multiple data streams
- Reusing data to facilitate decision making
- Providing easier ways to expedite the planning process and monitor the trial in real time
- Optimizing workflows and collaboration
Effectively deploying an eClinical solution
Deploying an eClinical solution can involve technological challenges, changes in strategy and a need for organizational and/or behavioral changes. Clinical trials are complicated enough without the addition of a new technology that could require modifying workflows and training users.
To effectively deploy and operate an eClinical solution requires access to clinical trial technology and process experts fluent in study design, randomization, trial supply management, clinical data management, clinical outcome assessments (COA) and ePRO, and local regulatory issues.
That expertise should include integration services from existing legacy systems to novel solutions and third-party applications. In addition, experts should be available to support the technology, ideally via a single-point-of-contact help desk for global trials. You can lower the risk in implementing and operating an eClinical solution by working with an experienced clinical trials technology partner to configure, deploy and support the solution.
From an enterprise perspective, an eClinical solution simplifies workflow and makes it easy to deploy multiple solutions within a single study or portfolio of trials. With enterprise-level reporting, users can answer key questions regarding the performance of multiple studies, including recruitment progress, country and site activation progress, data management activities and clinical supply chain health status.
Enterprises using eClinical solutions are able to identify risk signals and trends that can lead to faster, proactive interventions by study teams at sites where potential problems are identified. Organizations benefit when implementing eClinical solutions by:
- Minimizing data fragmentation
- Eliminating manual data and application integrations
- Reducing resource bottlenecks
- Improving the trial build process and accelerating first patient in by making it easier to configure and/or customize technologies to implement the study protocol
- Identifying cost- and time-saving opportunities
- Increasing team collaboration
- Accelerating study start up and database lock
Companies that use eClinical solutions decrease data fragmentation, improve decision making, and gain a significant competitive advantage over their peers by simplifying the journey from new molecular entity or medical device to market. Biopharmaceutical and medical device companies are increasingly recognizing data as a strategic asset.
Read the full paper "Accelerating The Clinical Development Journey With Improved Data Management"