Regulatory Overburden and the Role of eRegulatory Systems



It is a well-established fact that clinical research is becoming increasingly complex. A Tufts analysis, published in the year 2018, found that clinical trials have seen a tremendous increase in protocol design complexity over the last decade. As noted in the Tufts report, from 2001 to 2011, the total number of study endpoints has increased by 86%. Companies are aiming for global approvals, while running clinical trials simultaneously in multiple countries with each country having its own regulatory requirements. Moreover, the emergence of novel types of trial designs, such as adaptive, basket, and umbrella trials, as well as a shift to decentralization, has put a greater emphasis on data coordination and integration.
With an increase in the complexity of clinical studies, the regulatory burden on the study coordinators has become even greater. Coordinators are expected to deal with the innovations in clinical trial methods, growing complexity of multisite trials, increasing volume of data, and the constantly evolving regulatory requirements. This is on top of their role in patient care.


The role of a study coordinator in patient care

A study coordinator holds a central position in clinical research activities and serves as an interpreter or liaison between the principal investigator and the trial subjects. They are tasked with protocol adherence, recruiting subjects, obtaining consents, collecting data and maintaining the regulatory binder. Yet the most important task that a coordinator has is being a caregiver. A coordinator educates patients about the clinical trial, obtains informed consent, and alleviates subjects’ fears regarding medical research. Hence, a study coordinator is often the “face” of the study for the subjects and it is through them that the participants develop the trust that they are being cared for.
To an outsider, it may come as a surprise that one of the most time-consuming tasks for a study coordinator revolves around regulatory compliance. Coordinators often spend a disproportionately large amount of time handling and storing regulatory documents, much of which fails to provide direct value to the patients or to the quality of the research being conducted.


More time spent on regulatory tasks rather than patient care

According to one industry survey that involved personnel from 164 clinical trial sites, an average of $13,901 is spent on completing the regulatory tasks during a typical 2-year study. Also, on average, 34 hours per week are spent by the site staff on clerical activities, 36 hours per week are exhausted on regulatory work, and 44 hours per week are spent on sponsor/CRO-related activities.
Here are some examples of how a study coordinator spends valuable time on regulatory tasks that can negatively affect work efficiency:

Tracking down other study personnel: Tracking down principal investigators and waiting outside their offices to collect signatures, waiting for another staff member who is off-site to come back and review or sign a document, and waiting for files to be retrieved from storage can take up a huge chunk of a study coordinator’s precious time; time that could instead be directed toward other revenue-generating activities.

Correcting errors: An enormous amount of time is spent correcting errors that result from missing information, incorrect filing of documents, and accidental misplacement of important data.

Performing repetitive tasks: Storing the same information in a paper binder as well as on a shared drive, reviewing the files in order to prepare for a site monitor visit, and responding to redundant requests from site monitors are some of the time-consuming, repetitive tasks in which study coordinators often get caught up. As a result they fail to utilize their full potential for the success of the study.


The benefits of Electronic Regulatory (eReg) systems

Technologies, such as electronic medical records (EMRs), have proved to be of great significance in improving health outcomes, reducing costs, and ensuring patient safety. Similar technologies have also been proposed to improve the efficiency of the clinical research process. An eRegulatory system is one such technology; an electronic or virtual regulatory binder that helps transport data to an easy-to-use digital interface and eliminates the need for maintaining bulky, space-consuming, paper binders.


Below are some of the advantages associated with the use of eReg

Improved clinical trial site efficiency: eReg frees the study coordinator from the tedious job of maintaining and storing regulatory documents, and allows them to deal with more important tasks, such as providing high-quality care to the study patients. It also reduces the risk of errors and ensures that standard clinical data is available in real-time to all the personnel involved in the study, enabling them to monitor the systems remotely.

Increased accuracy: The use of eReg decreases the need for performing redundant manual tasks, thus, decreasing the risk of errors in the collection and storage of regulatory data and improving regulatory compliance.

Reduced costs: The improved trial site efficiency potentially allows the site to enrol more participants in a shorter amount of time. It also decreases the need for hiring a large number of site personnel to manage repetitive administrative tasks. Hence, the use of eReg can help lower the expenses for any clinical trial site. – an eReg solution that puts you in control!

The use of eReg can rid the study coordinators of the regulatory burden and allow them to focus more on patient care, thus, increasing patient satisfaction, and consequently, increasing rates of participant enrolment and retention.’s eRegBinder is an eReg solution that can help streamline the clinical trial process by organizing regulatory binders and keeping track of all the essential documents. Schedule a demo and become familiar with an eReg system that puts you in control!