Clinical research associates (CRAs) fulfill an essential role in the trial environment, performing monitoring activities at every stage in the research lifecycle. Building strong relationships with these employees is critical for ensuring the trial runs smoothly – including providing staff with dedicated line management support and technology solutions that can help automate or streamline time-intensive tasks. We recognize that this core group of staff work long hours often characterized by large amounts of manual data capture required for their jobs.
These data capture tasks can be burdensome and repetitive, adding hours to a CRA’s day spent juggling multiple data systems to find the information they need or entering results manually in a database only accessible via their computers (which requires them finding space at crowded sites to use their computers via a secure Internet connection) before heading out to the next site. It also takes them away from more strategic monitoring and relationship-building elements of the job. This is an untenable situation that CROs, sponsors and site leaders can’t afford to ignore. So we set out to mitigate this frustration among our CRA employees and to make their jobs more efficient. Our solution: The Site Visit Mobile app.
In late 2015, we rolled out this new custom app for CRAs in order to drive efficiencies and make their jobs – and their lives – easier. The app allows them to conduct many tasks on the fly, simplifying the site visit process and eliminating a good portion of lag time in the CRA’s workday. Now, CRAs can perform key site visit tasks, like scheduling a site visit or update the status of a study visit, on-the-go through their smart phones instead of depending on Clinical Trial Management System access via their computers. The app captures data real-time and delivers a custom view curated for each user, eliminating the need for CRAs to scroll through a seemingly endless list of sites to find their assignment and reduces the time they used to spend traveling back and forth from sites back to their office or hotel room to manually log information.
Since its launch, the Site Visit mobile app has been key to streamlining the CRA’s day, though the benefits of app extend far beyond the individual employees. It also positively benefits site staff and sponsors. By streamlining many of these tasks, CRAs can complete their monitoring more quickly, which reduces delays in the clinical environment, shortens the time to identify anomalies in the research environment, and strengthens the predictable quality of the data captured, which benefits everyone engaged in the research.
Our work doesn’t stop at the Site Visit app – we are continuing to develop fit-for-purpose applications for clinical study team members to optimize the use of current systems including the Clinical Trial Management System, electronic Trial Master File system and other workflow management tools. Adopting new, emerged technologies within clinical operations is required to improve operational performance – and now is the time to accelerate integration and adoption of mobility, the cloud and advanced analytics.