By Lauren Sims, Product Manager
The clinical trial industry is relying more and more on remote capabilities for Patient data capture, and organizations are working to implement options that provide an overall streamlined approach, with immediate access to the data collected. We know that there are important considerations when selecting the tools that will be implemented.
The Datatrak Enterprise Platform, which includes our Datatrak Direct app, provides a cloud-based set of tools to help you with your decentralized or hybrid studies. Our setup allows for designing and adding digital data capture to new or existing trials, and we have thought carefully about the impact to all contributors to the process including patients, site staff, study teams, sponsors and EDC programmers.
Newly Initiated Studies
When implementing a new study, one of the first considerations is where in the process digital data capture should be implemented. Flexibility and patient focus within that process are imperative, along with these considerations:
Datatrak’s experienced team is able to review the process end to end, and suggest the best approach to adding an effective digital data capture component to the new study. The impact of COVID-19 on clinical trials over the last few years has already been significant, and has limited the ways in which that patient feedback must be collected. Based on this new normal, and the lingering possibility of additional shut downs or impacts, the sooner a digital solution can be implemented the better.
Studies Currently in Process
There are several areas to review when looking at opportunities for digital data capture within an existing study. These might include amending the protocol, updating system configuration, validation, UAT, updates to business processes, and deployment of the changes. With the Datatrak Enterprise Platform, we offer a solution that includes no study downtown, with focus on flexibility and user experience.
Datatrak has created a unique process that implements mid-study changes with no required study downtime or movement of study data, while allowing users to stay online. This ensures your trial stays on track and allows you to implement decentralized or hybrid solutions to your existing trials.
Implementing digital data capture into your clinical trial is the best option, and Datatrak has the knowledge and tools to help you get started as part of a new or existing study. Learn more about the ePRO/eCOA options in the Datatrak Direct tool at our webpage, or reach out to one of our experienced team members today to request a demo of this innovative solution.