Leverage Technology For Data Aggregation from Disparate Sources
Sponsors are facing intense pressures to change the way clinical research is conducted in order to decrease costs and speed up the research and development process.
Equally important data management challenges are:
1) The ability to enhance data sharing between partners such as study sites, CROs, clinical trial monitors, and development partners such as small or large pharmaceutical and biotechnology companies, and
2) The ability to gain impactful insights from clinical data. Sponsors are searching for comprehensive clinical solutions that leverage technological advances such as cloud computing, data analytics, and data repository solutions to easily and cost-effectively collect information, and share and gain insights from their clinical trial data.
Leveraging technology to speed up clinical trials is a multi-faceted initiative. The first step in this process is aggregating clinical data.
Most sponsors have adopted electronic data capture (EDC) systems in conducting clinical trials, and having an EDC system in place is a critical component in integrating your clinical data from disparate sources in one system.
To fully leverage technology to reduce costs and increase efficiencies to your clinical trial processes, consider the following:
- Global library of standard and individual forms—Establish a global library of standard forms and components of forms that can be used to set up new clinical trials and studies
- Dynamic management of lab data—No matter how lab data is collected whether through local or central labs, EDC systems can automatically collect all lab data and standardize it into pre-determined parameters.
- Integrate coding and safety systems—EDC systems can integrate with existing coding systems to collect adverse events and medications used during a trial in a standard format. Collecting this electronic data capture in clinical trials brings efficiencies to the coding process, decreases costly inconsistencies, and enables data comparisons across studies.
- Targeted Source Data Verification—EDC systems centrally store data, which allows sponsors to re-define how monitoring is structured and conducted. New approaches to source data verification (SDV) and clinical trial monitoring have the potential to improve safety, data quality, regulatory compliance, and overall trial validity while reducing monitoring costs and time needed to “lock” the database.
- Electronic Health Records/Electronic Medical Records—Consider how EHRs can be used in your clinical trials to determine protocol feasibility, accelerate patient recruitment, and conduct retrospective and prospective trials.
- Mobile health devices to capture vital signs–Today mobile health devices including wristbands, socks, temperature sensors, and clothing capture and report vital signs. These devices collect and share data, as well as initiate follow up through text and e-mail messages. Look for opportunities to include mobile health devices in your clinical trials.
Advances in technology offer opportunities to enhance the quality of the data collected, decrease the cost to collect data, and increase the speed and efficiency of clinical data collection and data aggregation. There is a tremendous amount of clinical data available to sponsors. The challenge, and the opportunity, is to leverage your clinical data for meaningful insights that drive decisions and actions, and to begin this process clinical data must be integrated.
How are you currently aggregating data from your clinical trials? Share with us what is working well and what areas you are struggling with.
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