Paper has traditionally been used as the primary medium to store study-specific information and regulatory documentation in clinical trials. Frequently study coordinators are charged with the Herculean task of maintaining paper-based regulatory binders, in addition to seeing patients and performing other clinical duties. While the heavy reliance on paper-based systems appears to be innocuous, in practice, it leads to many challenges that can create significant hurdles for a clinical trial site.
In this article, we will try to uncover some of the hidden costs, both financial and operational, associated with the use of paper binders.
1. Increased financial burden
It is unavoidable that clinical trials are becoming increasingly expensive, and the cost of developing and gaining approval for new drugs is sharply rising. The high cost of operating a clinical trial site impacts drug development costs and has a real and immediate impact on public health. Part of the cost is passed on to Sponsors, thereby affecting their ability to conduct new trials, thus, limiting patient access to novel treatments.
From the site’s perspective, storage & archiving costs of physical binders, paper, ink, and other office supplies add significant overhead to conducting trials. The cost of these materials accrues throughout a study and adversely impacts the trial budget. An industry survey found that for an average 24-month study, an estimated $1,226 may be spent on materials, which includes money spent on paper, folders, binders, and storage boxes. Additionally, paper documents are often must be retained for 11 or more years. Archiving paper for this length of time will result in additional costs for a trial site.
2. Additional storage space requirements
The voluminous records vital to a clinical trial may require multiple binders for storage. It’s not uncommon for study regulatory documents to consume four or more binders, each exceeding 500 pages!
These binders grow throughout a study, and the need to physically store these vast stacks of papers is a significant concern for many clinical trial personnel. To ensure adequate and secure storage of paper documents, some sites set aside up to 15% of their physical office space. In some cases, the dedicated office storage space may increase up to a staggering 25% or more!
3. Enhanced risk of losing invaluable work
The use of multiple binders, potentially stored in different locations, combined with the large volume of paper, increases the likelihood of misplacing or misfiling essential documents. In addition to opening you up to FDA findings, valuable work may be lost and subsequent time spent recovering this work.
A recent survey found that 71% of CROs have issues with the tracking and reporting of paper documents. 59% of the respondents had problems with misfiling or missing documents, while 48% reported difficulties with manual document exchange. All these issues may lead to a site missing deadlines for renewing vital documents, such as study personnel CVs and licenses, and may create significant problems for the site if the FDA audits them.
A few years ago, the use of paper-based regulatory binders was the industry norm. However, the increased awareness regarding the hidden financial and operational costs and the business risks associated with the use of paper resulted in physical binders being replaced by electronic regulatory (eReg) systems. The eReg system provides a digital platform for storing and tracking regulatory documents and helps ensure a smooth flow to a clinical trial.
Clinical.ly can help you avoid the hidden costs of paper!
Clinical.ly’s eRegBinder is a purpose-built electronic documents storage and trail management system that helps to digitize and organize your essential regulatory documents. By lowering the paper burden, it serves as a cost-effective solution that saves both time and money for trial sites and Sponsors while reducing the storage space requirements and mitigating the risks of losing critical work at the same time.
Get in touch with Clinical.ly today and let us take care of your paper burden for you!