In our last blog, we brought up the topic of vaporware in clinical research data management. Clinical trials require a lot of tech to collect, manage, and analyze data, and there are so many providers putting out claims about what their products can do. Certainly, we’ve all been in positions where a potential vendor seems to be saying all the right things about how their technology works and it can make our lives – and studies – easier. When it comes to your eClinical platform, though, getting sold on features that don’t live up to the sales pitch – or don’t even exist yet – can have real and costly consequences. Building on the ideas covered in the previous blog, we’ll delve into some other questions you can ask a potential platform partner to help ensure you make the best choice for your studies.
I Need to Get My Studies Started Faster. How Does Your Platform Help?
Can It Streamline Study Design and Deployment?
A robust eClinical platform should offer an intuitive interface and comprehensive configuration tools that give researchers the ability to design and deploy studies rapidly without complex programming skills. From creating detailed electronic case report forms (eCRFs) to setting up multi-arm studies, the platform should simplify each step of the study design process. User-friendly drag-and-drop functionality can ensure that even complex protocols are swiftly translated into actionable study designs.
Can It Expedite Training?
Comprehensive and easy to implement training resources and support can be a huge help in speeding up study starts. New users should be able to quickly become proficient with the platform in a matter of days – not weeks or months. This can be accomplished by giving them access to useful documentation, video tutorials, and backing all that up with responsive customer support. This reduces the learning curve and allows teams to focus on critical study activities sooner.
Does the Platform Support Role-Based Views and Tasks?
Role-Based Access Control (RBAC)
There are a lot of different stakeholders that need access to study data, and a bad system can result in confusion or worse. If one user finds their way into the wrong database, a lot can go wrong. This is where an intuitive, role-based access control system can help. An effective platform should support extensive role-based permissions, which can be configured for users at every level of the platform. This granular control ensures that users only have access to the features and data necessary for their specific roles, enhancing both security and operational efficiency.
For example, clinical research coordinators can be granted access to data entry and reporting tools. At the same time, data managers and data monitors may have permission to do CRF review, query ability for fields and forms, and final signoff for data completeness. This guarantees authorized users or guests are only given access to what they need to do their jobs.
Can I Make Mid-Study Changes on the Fly?
The Power of Real-Time Modifications with Version Control
With so much going on in any given study – hundreds of moving parts – changes are inevitable. Sometimes it can be as simple as rewording outcome report forms, but other times changes to the study protocol itself may be necessary. Some eClinical platforms are able to facilitate real-time modifications, utilizing sophisticated version control processes that make sure all changes are tracked. This capability allows study administrators to make necessary updates without interrupting ongoing studies or the data collection process. Whether it’s a protocol amendment or an update to a data collection form, platforms – like TrialKit – offer version control that ensures seamless transitions and continuity, maintaining the integrity and consistency of your study data.
Can I Tailor Query Management to My Specific Study Needs?
Customizable Query Management
Effective query management is essential for maintaining data quality and integrity. Truly comprehensive eClinical platforms can offer research teams wide ranges of tools that allow them to customize their query management based on the specific needs of any given study. They are your studies, so don’t hesitate to ask any vendor if they can offer features like:
- Field, Form, and Visit Level Edit Checks/Queries: These customizable checks help ensure data accuracy at various levels of data collection.
- Automated Query Generation and Notifications: Failed edit checks can automatically generate queries and send data management notifications via emails and texts, complete with links to the relevant queries.
- Customizable AE and SAE Notifications: Adverse event (AE) and serious adverse event (SAE) notifications and reports can be configured based on specific query conditions.
- Detailed Permissioning and Routing: This ensures that queries are directed to the appropriate team members immediately.
- Integration with External Systems: The platform’s architecture should allow for seamless integration with other systems, enabling automatic query triggering and management across platforms.
Can I Build My Study Any Way I Want, Via Web or Mobile App?
Web and Mobile App Capabilities
TrialKit is a unique eClinical platform because it supports both web and native mobile study build capabilities.
- Mobile App Study Builds: Building studies via a native mobile app offers a great deal of flexibility, enabling teams to build studies that look and feel consistent whether users interact via mobile device or via a web browser. Mobile build capabilities offer many distinctive features such as customizable fonts and field properties, and tools like pain scales, sketch pads, and horizontal sliders, providing a more modern user experience.
- Web-Based Study Builds: Some team members may be more comfortable working with web applications for study builds. Platforms like TrialKit provide these users with the option to choose how they prefer to interact with the system.
Further, using the TrialKit app, users can go back and forth between mobile and web. Different team members can contribute to the study build in different ways without worrying about data loss.
My Team and I are Swamped – Can Your Team Build My Study for Me?
Study Build by Crucial Data Solutions
Flexibility can also apply to the study build itself. With TrialKit, the Crucial Data Solutions team wanted to make it easy for teams to build their studies the way they want, without needing a lot of development expertise. Still, we understand that there are many research teams that are running lean and are managing multiple responsibilities all the time. For them, we can offer a more turnkey solution, building out their studies on the TrialKit platform to suit their needs, freeing them up to focus on other important aspects of their development work. This can help them have a study ready for first patient in (FPI) within 4-8 weeks. This process involves:
- Immediate Study Build Initiation: Upon receipt of CRFs and protocol, the study build process can begin immediately after the kickoff meeting.
- Review Cycles: Typically, 1-2 review cycles (Online UAT) is conducted to refine the study design.
- User Acceptance Testing (UAT): Final drafts are usually ready for final workflow UAT within 2-4 weeks.
- Auto Validation: Auto-validation, unique to TrialKit, provides study builders a tool to enter test data in a simulator for each form. The system will then automatically run that data against the edit checks (validation conditional actions) on the corresponding form being validated. It then records where the edit checks fired and where they didn’t.
- Go Live: Publish the study and go live. This is the final step after the study is thoroughly validated.
Conclusion
Selecting the right eClinical platform is a decision that significantly impacts the efficiency and success of your research – it’s important to get this choice right. An ideal platform offers a comprehensive suite of features tailored to meet the diverse needs of your clinical trials. From robust role-based access controls and real-time study modifications to customizable query management and flexible deployment options, a reliable platform provides a versatile and dependable solution for modern clinical research.
In an industry that depends on the accuracy and reliability of data, having the right tools and flexibility needed to navigate the complexities of clinical research with confidence are essential. Whether you are managing a small-scale study or a large, multi-center trial, you owe it to yourself and your team to ask potential partners all the questions you need to make sure you are getting a platform that can handle the needs of modern research.
Contact us today for more information about clinical data management and the capabilities of TrialKit.
