Bringing a therapy to market is complex and costly. Billions of dollars and thousands of hours are spent seeking regulatory approval, but only a handful of innovative therapies make it to patients, even with extensive investments of time and expertise. Unnecessary friction and inefficiency in the process limit the pace of progress.
One of these unnecessary friction points is a lack of data quality. Life sciences processes require extensive data to flow among stakeholders, participants, and decision makers. These include sponsors, clinical research organizations (CROs), study investigator sites, and others, who need to effectively collaborate to provide quality data throughout the clinical trial process.
Unfortunately, the lack of transparency in the data flow often inhibits speed of decision making and the quality of data. This, in turn, lengthens the duration of clinical trials, results in unnecessary expenditures, and delays the ultimate delivery of therapeutics to patients.
Why Data Quality is Important for Clinical Trial Stakeholders
Sponsors and CROs are two of the most active stakeholders involved in clinical trials. Therefore, they are heavily involved in ensuring the quality of data throughout the process.
Sponsors rely on extensive data points to make critical assessments about the viability of therapies in clinical trials. If data points are missing or inaccurate, decisions sit in limbo, resulting in costly delays.
CROs are in charge of managing, designing, monitoring, and reporting on all aspects of clinical trials, including patient enrollment and participation. For CROs, data quality is at the top of the list of important ingredients in clinical trials.
There are also particular aspects of clinical trials that necessitate an emphasis on data quality. These include:
Decentralized Clinical Trials
The move toward decentralized clinical trials, with a greater number of investigator sites with potentially less experience and infrastructure, calls for more process management to ensure data is collected and flows without affecting quality and timelines. Consistent decision-making and proper oversight are all central to achieve reproducible results.
Data Security
Investigator sites must routinely deal with confidentiality, data privacy and integrity. They must ensure that any Personal Health Information(PHI) is redacted before data is shared across a complex clinical trial ecosystem of stakeholders and decision makers. Data in clinical trials must be supported by a secure environment where the right stakeholders with the proper credentials can query and gain insight from the data to ensure faster, and better, decision making. Data security is compromised when non-compliant systems such as email or shared files are used as the means to collaborate.
Lack of Automation & Outdated Technology
Paper-based approaches to clinical trial data collection and distribution place significant time, cost, and resource burdens on organizations. They are also prone to errors and may cause rejection by regulatory boards (e.g., FDA, EMA). Quality data exchanges between entities remain difficult and are often costly to implement.
How Judi Resolves Data Quality Issues
According to a Deloitte article titled Intelligent Clinical Trials, “Consolidating all data – whatever the source – on a shared analytics platform, supported by open data standards, can foster collaboration and integration and provide insights across vital metrics.”
Judi is more than just a shared platform. Judi's cloud based solutions platform supports trial sites, sponsors, CROs, and other partners on a range of workflows specific to clinical trial management. Built in close collaboration with our many partners, it is designed for you, and can be used to enable and streamline all use cases.
To overcome complex operations that require extensive collaboration, Judi connects all phases of the process and provides a secure, cloud-based system with quality-assurance measures built-in.
To overcome regulatory and data security issues, Judi provides comprehensive audit trails and user-friendly digital submission processes designed to meet strict guidelines.
To overcome a lack of automated processes and outdated technology, Judi securely collects, transfers, and stores data in any format, with auditable, 21 CFR Part11 compliant communication.
Contact us to learn more about how Judi can help automate, expedite and improve outcomes in your clinical trial.
