Managing clinical trials using Microsoft Excel is a norm within the clinical research industry, particularly for smaller research sites. However, as clinical trials increase in complexity and research sites grow, spreadsheets become a liability and hindrance for your site. Despite technological advances in software solutions that increase the accessibility and affordability of clinical trial management systems (CTMS), many sites still rely on spreadsheets. Here are five reasons spreadsheets cannot keep pace with a CTMS.
1. Inefficient Workflows
Spreadsheets are inexpensive, straightforward and relatively customizable, but they are not designed for clinical trials. Excel spreadsheets provide little to no visibility into supporting tasks within a study, and prohibits multiple users from editing the spreadsheet at the same time.
A great benefit of a CTMS is that it’s designed to create efficiencies in your day-to-day operations so you spend less time managing the system itself, and more time focusing on the demands of the trial. Clinical trial management systems should have prescriptive workflows built in, making it easy to identify and follow the next step in the process for its users. Some CTMS’s automatically show or hide particular features according to the user, to increase efficiency across different roles.
For example, using Forte’s Allegro, you can build checklist templates related to specific workflows that you can then apply those checklists to all protocols in your system, so you can feel confident all coordinators are completing the same steps across all studies consistently.
2. Lack of Data Safety and Integrity
With multiple stakeholders involved in managing various aspects of clinical research across your site, it is important to track who is responsible for which data to ensure data reliability and reduce human error. A spreadsheet does not offer the ability to limit access to sensitive data, and it cannot be used to track who has edited what information.
A CTMS, on the other hand, offers far greater security, since it is only accessible to users who have unique usernames and passwords. Additionally, a CTMS should offer audit trail functionality, whereby application administrators can view which users have made which changes, so that they can identify and resolve any input errors.
Lastly, when using spreadsheets, users can accidentally delete data with a press of a button. A cloud-based CTMS is backed up consistently, so that at any given time you can revert to a former version of the CTMS and recover anything you may have accidentally lost, ensuring the safety and integrity of your data.
3: Inability to Scale
Growing your site successfully depends on your ability to efficiently scale. As your site continues to grow, take on more complicated studies, or increase your research volume, smaller inefficiencies in your workflow will begin to hinder your site more and more obviously. Using spreadsheets divides all of your protocol information across different files, whereas a CTMS can track all your protocols and associated documentation within a central system. Tracking the same data points in the same system enables you to easily identify opportunities to refine your operations.
4. Limited Reporting Capabilities
Building reports in Excel takes time away from billable tasks and other important elements of managing a trial. Spreadsheets are limited by data point formats, and require frequent rebuilding and running. Using a CTMS, you can report in multiple formats at the push of a button. A CTMS should also offer standard off-the-shelf reports, including data points other sites like yours have found valuable to their operations, specific to clinical research.
5. Lack of Integration with other solutions
In addition to a CTMS, there are a variety of other technological solutions that can help your site meet its operational goals. When you rely on spreadsheets, you miss out on the opportunity to leverage interfaces with other systems to further streamline your day-to-day processes and give insight across departments.