Buyers Guide

Table of Contents

• What is Clinical Trial Management Software?
• The benefits of Clinical Trial Management Software
• Typical features of Clinical Trial Management Software
• The cost of Clinical Trial Management Software
• Considerations when purchasing Clinical Trial Management Software
• Relevant Clinical Trial Management Software trends

What is Clinical Trial Management Software?

Clinical trial management software helps clinical research sites, hospitals, and other pharmaceutical/healthcare companies manage all aspects of clinical trials. These software systems maintain and manage patient data, scheduling, finances, reporting, analysis, and research data.

Clinical trial management solutions also help organizations protect patient health and financial data to avoid regulatory compliance issues. This type of software can also provide tools for patient enrollment, recruitment, study planning, and benchmarking clinical research progress. The software also integrates with patient texting, remote payment, and video conferencing solutions.

The benefits of Clinical Trial Software

Clinical trial management software offers numerous benefits to everyone who conducts clinical trials:

• Increase efficiency: Clinical trial management software automates numerous processes and centralizes trial data, enhancing the efficiency of clinical trials. Having a centralized location for all documents removes the need to enter data manually into different locations. This capability reduces the likelihood of making errors due to duplicate or missing documentation.
• Improve data management: Clinical trials generate large quantities of data. A clinical trial management software platform provides a single, secure location for data collection, storage, and retrieval. This makes it easier for everyone involved to access and distribute information, such as data reports and study documents. Clinical trial management systems can also generate detailed reports and verify the status of individual or multiple clinical trials, which boosts efficiency for researchers conducting multiple studies at once.
• Streamline financial management: Accurate tracking of clinical trial financial data ensures accurate sponsor invoices and correct payments for each site involved in the trial. A clinical trial management system can create a detailed study calendar that streamlines tracking of trial-related costs. The system also automates many routine financial tasks, creating consistency in budgeting and billing processes.

Typical features of Clinical Trial Management Software

Here are some of the most common features of clinical trial software:

• Compliance management: Ensure compliance with regulatory requirements, such as 21 CFR Part 11 and HIPAA regulations. This capability is especially important for validated systems of record with regulated data, including electronic visit reports or site-essential documents.
• EMR/EHR: Create, store, and update patients' digital health records. Digitized patient information and medical records improve clinical reporting and care coordination in response to patient data.
• Document management: Collect, upload, store, and share electronic documents within a single database. This helps organizations maintain an integrated and organized clinical research trial process.
• Financial management: Track all budgets and payments within a single solution to provide a comprehensive overview of the organization's finances. The feature can also create invoices and manage accounts payable and receivable.
• Patient recruiting: Find new trial participants and maintain their information in a centralized database. Organize and track potential participants from first contact through study enrollment.
• Clinical study management: Create and manage the numerous aspects of clinical trials. System capabilities take the clinical trial team from startup to team enrollment, participant monitoring, tracking deadlines, and reporting of research study results.

The cost of Clinical Trial Management Software

Most products in this market are priced on a "per user, per month" basis. Pricing can be divided into three pricing tiers based on the starting prices:

Price ranges*:

• $14 - $33
• $33 - $849
• $849+

*The pricing included is for the entry-level/lowest-priced offering found on vendor websites on October 12, 2020. These ranges correspond to the 25th, 75th, and 100th percentiles of pricing information gathered from vendor websites of sample products.

Considerations when purchasing Clinical Trial Management Software

Keep the following considerations in mind when evaluating clinical trial management software:

• Mobile adaptability supports overall trial efficiency: Clinical trials often feature numerous trial sites and remote workers. The software platform you invest in should have integration capabilities with digital devices such as smartphones, tablets, and notepads. Mobile-ready software allows clinical trial staff to work from anywhere at any time without loss of functionality.
• Identify compliance requirements: The clinical trial management solution you select must meet the FDA's 21 CFR Part 11 regulations and HIPAA standards for patient data protection. Verify that the software is not outdated, it meets current standards, and there are processes in place to make adjustments for future changes in compliance standards. Depending on your needs, there may be other regulatory management features to consider. For example, you may benefit from a software solution that offers custom security settings, data archival, and audit trails for any data changes in the system.
• Factor in ease of use: Clinical trial management software can reduce study costs and increase efficiency, but only if your team can use it. Software solutions vary in size and complexity, and an intuitive user interface helps team members learn to use the system. Ask the vendor for a demo trial of their clinical trial management software to ensure that it fits your needs.

Relevant Clinical Trial Management Software trends

• Automation with machine learning streamlines patient recruitment. Patient recruitment for clinical trials is typically a manual process, with research staff analyzing available data to identify suitable participants. This is a time-consuming and error-prone process that can miss or erroneously assign patients, which damages the trial quality. Automated patient selection with machine learning can automatically screen EMRs/EHRs, find matches between specific patients and trial requirements, and display the results in a comprehensive dashboard.
• Siteless trials reduce participant drop-off rates. Traveling to trial sites expends a participant's time, effort, and money. With siteless trials, all steps of a clinical trial are conducted through mobile apps, remote patient monitoring, and audio/video calls. In addition to improved patient management, siteless trials may also reduce patient enrollment time and generate more diversity in trial participants. Recent additions to clinical trial software features include eSource, eConsent, and eRegulatory that help mana