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:
What is clinical trial management software?
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)
Common features of clinical trial management software
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.
||Allows users to plan and enroll targets (number of required patients) for different clinical trials.
||Allows users to create, manage, store, and track electronic documents within a single 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.
||Allows users to schedule patient visits for specific clinical trials that match the patient's profile.
||Allows users to ensure compliance with regulatory requirements, such as 21 CFR Part 11 and HIPAA regulations.
||Allows users to track payments, maintain invoices, and manage accounts payable and receivable.
||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.
What type of buyer are you?
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.
- Small and midsize CROs (5-100 employees): These CROs are usually founded by individuals or groups of physicians/scientists with expertise in a specific field. They have fewer employees, focus on a niche area of research, and usually operate out of a single location. Such buyers should consider software with features that are aligned with their area of clinical research or specialization. Some of the common software features they should consider are enrollment management, document management, patient database, and patient scheduling.
- Large CROs (more than 100 employees): These CROs have a larger number of employees and several clinical research trials and studies on their annual agendas. They have to manage large volumes of data—documents, contracts, and financial transactions—for all the patients involved in trials. They also have to take care of legal and compliance requirements for clients, mostly big pharma companies. Such buyers should opt for a complete clinical trial management software suite that offers features such as compliance management, financial management, reporting, and third-party integration.
Benefits of clinical trial management software
While some of the benefits of clinical trial management software may already be evident, we've listed the most notable ones in this section.
- Ensuring compliance: Large volumes of data (patient data, billing information, study designs, deadlines, etc.) are processed during clinical trials. The software helps streamline the clinical audit process by tracking, managing, and consolidating all data into a single, centralized system. It also consolidates data from previous internal and external audits, compliance certificates, and other related processes. Further, it tracks any process deviations in daily protocols.
- Tracking financial data: Clinical trial management software ensures accurate invoicing for all stakeholders and timely payment for all research trials and studies. It also lets CROs monitor their bottom lines to help control costs and filter out trials that aren’t bringing in revenue.
- Managing data: The software offers a single and secure location for data collection, storage, and retrieval. Information—such as patient data or clinical study-related documents—is stored in a centralized repository and accessed by all authorized personnel through a searchable library.
Key considerations when selecting clinical trial management software
Listed below are some important points to consider before you purchase clinical trial management software.
- Mobile app availability: The software you’re planning to purchase should be available as a mobile app on iOS and Android smartphones or tablets. Mobile-ready software will allow you to perform tasks such as enrolling patients, updating contact details, and signing documents digitally, even when you’re on the move.
- Customer support: Check out the type of support offered by your shortlisted vendors: 24/7, 24/5, or only during business hours. Also, ask about the available support channels, such as email, phone, or live chat. Support services will help you fix software issues that can hamper productivity or result in downtime.
Market trend to understand
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.