Study startups (SSUs) define the process flow starting from the first point of contact with the sponsor to the screening and recruiting process of subjects by the study team in clinical trials.
Clinical research companies or researchers usually work with an SSU workflow so that the entire process can flow smoothly with effective communication. While speed and efficiency are much-needed to improve study-startup, these are not just the only parameters to consider. In this blog, we have outlined some common tricks to improve your study start-up.
How has digitization revolutionized study start-ups?
In its initial days, technology was used mostly in the study conduct phase. As a result, systems like Clinical Trial Management Systems, Electronic Data Capture, Interactive Voice Response System, e-PRO, e-CRF came into existence. However, most of these systems didn’t focus on eliminating redundant tasks between CROs and sponsors, and neither study startup got any attention.
The changing landscape of study start-ups
However, with the time and evolution of the clinical trial, a paradigm shift has been observed in the clinical trial management landscape. As new countries and trial sites started entering the process, there has been a growing need to improve the study startup process and regulatory practices. Similarly, global and local CROs are now keener to work with the same clinical trial study sites, resulting in steep competition. And finally, another bottleneck that CROs and sponsors face in launching clinical trials is the cost, which leads to process delays.
Apart from delays, and rising costs due to the delay, another challenge is the patent cliff. A study report following a survey revealed that pharmaceutical companies lose billions in revenues from expiring patents for some highly crucial drugs.
Let’s see how we can create a differentiator in our study of start-ups.
Importance of technology in study start-ups and how can we implement it
Looking at the study startup history, one can say that adding more resources alone will not solve the problem. Companies have to leverage technology to bridge the gap for the deep process-based issues.
Digitalization and real-time overview
Sponsors or CROs can implement a technology-based solution to manage the entire setup process, ensuring no data is lost, thus minimizing the risk without impacting the clinical study. Similarly, with real-time data available, the project management team can focus on issues affecting the study. At the same time, real-time dashboards help everyone to view status without wasting time in discussing updates.
Being contemporary with mobile-friendly configurations
With the advancement in mobile technology, desktop reporting is being slowly taken over by mobile technology. Team members can now use smartphones and tablets to review reports or track any risks. All these efforts will soon give way to reduced time requirements for site activation. Mobile technology coupled with wearable technology is going to make business processes more agile in the coming days.
Finally, the incorporation of technology in study startup means saying goodbye to old business models and processes that haven’t evolved over the years.
The need for better communication
Apart from technological interventions in the study startup, focus on communicating with the CROs and sponsors closely with integrated CTMS solutions.
Being a sponsor and CRO ready
Most sponsors and CROs are fairly consistent in their processes and workflow, and you will get to see the trend after a couple of negotiation rounds or previous contracts with the same sponsors. So, if certain things were not approved before, avoid spending time to persuade the same in your communication. Similarly, if you are aware of a CRO who has a specific sponsor escalation process, keep your documents updated and ready so that you can send them right away when you first send the budget or your contract agreement to the CRO.
Outsourcing for better efficiency
Additionally, you may also consider specific outsourcing tasks (clinical trial services) that are outside your institutional capabilities and are too time-consuming. For example, you may consider outsourcing coverage analysis as it is a complicated procedure and need a lot of training. Outsourcing to a study startup company can help you speed up the process.
Study startups lay the foundation for your clinical trial study. Digitalization in clinical trials will help in better communication in study start-ups. Technologies leverage data portability, a centralized overview of study start-up data, enable rational decision making and a single stop view of the entire process.