Clinical data analysis relies on timely data collection. Study staff are tasked with screening a patient to confirming eligibility, scheduling study procedures, collecting biosamples, and handling regulatory submissions. Due to the busy nature of running trials, entering protocol data into the electronic data capture system (EDC) is often delayed and errors/discrepancies in entry are often made, resulting in queries. Electronic source can be used to streamline the entire clinical trial process and reduce errors by making sure that all source data is stored safely and securely in one place.
Improve efficiency.
By nature, running trials is tedious and time-consuming. It takes a lot of effort to keep track of data, study documents, patient visits, regulatory documentation, and more.
eSource streamlines this process by simplifying the way data is collected:
- Reduces paperwork by replacing paper-based systems with an electronic system that automates document creation, review and approval
- Improves communication between team members through faster transfer of data and documents
- Reduces time required to collect, review and analyze data due to automated reminders sent when survey responses are due
Enhance data quality.
Since clinical trials must adhere to rigid quality standards, eSource is designed to specifically reduce the burden on patients, sites, and investigators by eliminating paper documentation. The goal is to enhance data quality and reduce the risk of data loss, human error, and tampering by directly electronically submitting data instead of mailing or faxing in study documentation.
Reduce the burden on patients and sites.
Trials can be lengthy, complex, and require a lot of input from each subject. The process of collecting data from patients with their consent often involves paper forms, phone calls, emails and multiple clinic or hospital visits. This can be very time consuming for both the patient and site staff members who must spend their days managing these conversations rather than focusing on the trial itself. eSource provides an online portal that allows for secure data collection across all phases of a trial—from enrollment to study exit—while also reducing administrative burdens associated with paper forms and manual entry.
It’s safer to reduce paper trails in clinical trials that involve FDA-regulated products.
Reducing paper trails helps eliminate opportunities for fraud or abuse in clinical research. There are many different ways for data integrity issues to arise during a clinical trial. Whether someone enters inaccurate information into an electronic database or misrepresents their identity when signing an informed consent form on paper, all can result in serious consequences compromising the validity of high value trials. By using eSource’s electronic signature capabilities along with features like document-level audit trails or compliance reports, eSource limits mistakes that are typically made when conducting a study.
Electronic source offers cost savings and enhanced data quality in FDA-related studies.
The FDA is continually seeking new ways to improve patient safety and data quality. The electronic source offers an opportunity for sponsors to enhance a study’s efficiency, reduce costs, and ensure compliance with these mandates. By automating certain tasks that traditionally have been done manually, eSource makes trials more efficient and less stressful for everyone involved.
