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Clinical research organizations (CROs) face several challenges, such as conducting multiple trials simultaneously, adhering to regulatory compliance, and ensuring transparency in financial transactions. To deal with these challenges, CROs need to be proactive, and clinical trial management software helps them do that. The software assists CROs and other healthcare organizations in protecting patients’ health and financial data to avoid compliance issues.
There are various clinical trial management software applications available on the market. However, choosing software with features that are right for your organization can be time-consuming. To help you, we've created this buyers guide with the information you need to know when making a purchase decision.
Here's what we'll cover:
Clinical trial management software is used to manage clinical trials done in clinical research. It serves as a single, centralized repository to store all the clinical research studies conducted in a CRO.
The software helps CROs streamline daily tasks, such as team collaboration, performance management, tracking of deadlines, and regulatory document management. It also assists in planning, reporting, and benchmarking clinical research processes.
Clinical study budget analysis in Cloudbyz clinical trial management software (Source)
Different clinical trial management software vendors' features offerings will vary. Selecting software with the right features for you is easier when you know what the most common features are, and what they do.
Enrollment management | Allows users to plan and enroll targets (number of required patients) for different clinical trials. |
Document management | Allows users to create, manage, store, and track electronic documents within a single database. |
Patient database | Allows users to store patient data to run specific searches within the database based on multiple criteria, such as age, gender, body mass index (BMI), medical condition, and prescribed medication. |
Patient scheduling | Allows users to schedule patient visits for specific clinical trials that match the patient's profile. |
Compliance management | Allows users to ensure compliance with regulatory requirements, such as 21 CFR Part 11 and HIPAA regulations. |
Financial management | Allows users to track payments, maintain invoices, and manage accounts payable and receivable. |
Reporting | Allows users to generate different reports to convert data into actionable tasks in real time. |
Third-party integration support | Allows users to integrate the software with other existing software solutions, such as electronic medical records (EMR), for smooth exchange of patient health data. |
Before you start evaluating software options, you'll want to know which buyer category you belong to, so you can understand what to look for in a solution. Most buyers fall into one of the below categories.
While some of the benefits of clinical trial management software may already be evident, we've listed the most notable ones in this section.
Listed below are some important points to consider before you purchase clinical trial management software.
Virtual clinical trials: New technologies, such as wearable sensors, smartphone apps, and mobile health (mHealth), are paving the way for virtual clinical trials. In virtual clinical trials, all steps, including patient enrollment, data collection, and follow-ups, are executed through video or audio calls. Such trials are likely to help reduce patient enrollment time and result in a more diverse pool of participants. Pharma companies across the globe are increasingly collaborating with major players in the clinical care space to conduct virtual trials.
Note: The application selected in this article is an example to show a feature in context and isn’t intended as an endorsement or recommendation. It has been obtained from sources believed to be reliable at the time of publication.