At a baseline, effective clinical trial software should improve patient safety/experience, limit administrative burdens, and should improve communications between organizations within a clinical research organization. But this is just the tip of the iceberg.
When finding the right clinical trial software, clinical research organizations should consider the following factors:
1. Clinical Trial Software Compatibility
Clinical research organizations employees need to be able to access the clinical trial software from a number of locations throughout their sites. The clinical trial software hosting architecture should be robust enough to work efficiently from any location or device.
Clinical trial software hosting should meet all requirements imposed by HIPAA and other regulatory bodies. In addition, the clinical trial software should be agile enough to adapt in the face of shifting compliance regulations.
eClinical is a bundle of integrated applications that include CTMS and increase accuracy of information, efficiency of data gathering and sharing, ease of regulatory management and other aspects of clinical trial site management. Working together, these applications allow sites to digitize and automate clinical operations management under one convenient umbrella. eClinical components each perform specific functions and are a powerful tool to address many needs within an operation. These components include:
- eSource: Through direct digital collection of data, this tool creates an original record of important information, leading to greater accuracy and efficiency.
- eRegulatory: While regulatory information normally is stored in unwieldy binders, this solution digitizes the data and houses it in a user-friendly digital infrastructure, making it easier to use and less space-consuming
- eConsent: This obtains a patient’s informed consent through an easy-to-use interface.
3. Database Management
Clinical trial software should maintain thorough records of all medical, medication, and social histories of patients. It should also allow clinical research organizations to maintain contact with patients.
4. Patient Capture
Does the clinical trial management software allow clinical research organizations to track leads easily and efficiently and offer social integration and call workflow management in order to add patients to growing databases?
5. Marketing/Remarketing Features
Does the clinical trial software allow clinical research organizations to market to potential patients easily, leveraging marketing assets such as email, Facebook integration, and website integration?
6. Client/Patient Communication & Scheduling Capabilities
Whether it involves inter-organization communication or patient outreach, clinical trial software should offer a built-in scheduling and communication system that makes for a more seamless workflow.
7. Study Set Up and Management
Is the clinical trial management software able to quickly arrange all components of the clinical trial in one unified location?
8. Financial Management
Clinical trial software systems should be able to track all budgets and payments using a single solution. Additionally, it should be able to set and monitor budgeting, maintain invoices and manage payables/receivables.
Clinical trial software should offer robust reporting capabilities, giving clinical research organizations and research sites the tools they need (such as level 3 and 4 NCI reporting) to run reports in real-time, furthermore allowing them to turn data into actionable tasks.
10. Document Management
Electronic document capture and management are crucial to maintaining a seamlessly integrated and organized clinical research trial process.
11. Available Integrations
Depending on the needs of a clinical research organization, clinical trial software may require integration capabilities that allow for organizations to achieve an even more robust clinical research management system.
Finding the right Clinical Trial Management Software can be a rigorous process in and of itself. But a well-integrated system can spell the difference between success and disaster for Clinical Research Organizations.