Clinical trials are conducted to evaluate a new drug, device, medical strategy, or treatment. Likewise, it aims to seek new or develop methods of screening, diagnosing, curing, and preventing various diseases. Medical professionals in contract research organizations (CROs) and clinical trial facilities play a vital role in the success of clinical trials. They can use clinical trial automation to accomplish this goal.  

The biggest challenges in clinical trials include slow patient recruitment, regulatory and industry compliance, and managing multiple sites. Failing to meet enrollment targets can lead to a lack of diversity in clinical trials, which remains a major issue.  

Find out how clinical trial automation can help address these challenges by reading through this article.  

Clinical Trial Automation And Its Benefits

Clinical trial automation eliminates manual processes, such as creating case report forms and annotations. This technology frees clinical researchers from focusing on and performing repetitive, time-consuming tasks. That way, they can concentrate and spend more time complying, publishing, and advancing medical science. Robotic Process Automation (RPA) is one of the digital automation tools researchers use for clinical trials nowadays.  

Below are the benefits of clinical trial automation. 

1. Meets Regulatory And Industry Requirements

The Food and Drug Administration requires clinical research organizations to submit annotated case report forms (aCRFs). Clinical studies have markings or annotations that map data points on case forms to the names and variables of datasets, such as baseline data, interim visits, procedural-based data, outcome data, and laboratory measurements. 

Annotated case report forms must follow the FDA’s data technical conformance guide and the Clinical Data Interchange Standards Consortium (CDISC) industry requirements. But this clinical trial deliverable usually takes time to create, needing keen attention to detail. 

Automating annotated CRFs eliminates traditional, manual methods to save time and effort. It makes editing easier, allows quick identification and adding of all annotations to disparate sources, and ensures regulatory and industry standard compliance. 

Learn more about the annotated CRFs’ regulatory requirements by reading this original post at Formedix. 

2. Improve The Validation Process And Patient Recruitment 

Accurate validation is crucial in clinical trials, especially when developing medicines and vaccines. Clinical trial facilities and organizations can integrate RPA bots in the validation to comply with stringent regulations. 

In addition, clinical trial automation effortlessly increases participant recruitment. It speeds up identifying potential patients by reducing the effort of doing repetitive tasks at a clinical study’s patient recruitment stage. Hence, the success rate of participant enrollment is higher with automation.

3. Streamlines Clinical Trial Processes

Robotics software powered by digital automation can streamline clinical trial processes. Because clinical trial data management can be extensive, handling data manually could result in human error. With RPA, it could bring more employee and patient value as it ensures more accurate and error-free data handling.  

In addition, robotics software is a digital worker automated to perform end-to-end office-based functions. This clinical trial tool is programmable, like giving instructions to a human being, but with more accurate outcomes. RPA also streamlines data transfer processes, ensuring an excellent quality auditable trail.  

Because of the remarkable speed of RPA, tasks that usually take weeks to complete can be accomplished in just a few hours. Automation avoids data loss and quickly detects anomalies, streamlining clinical trial processes. The results from large clinical trials come out quickly to help the public benefit from new drugs and treatments.  

4. Improve Patient Experience 

Focusing on the time-consuming tasks of creating CRFs and manual data entry can compromise quality patient care. Changes in data gathering or procedures can lead to patient frustration, especially when dealing with other life problems. In addition, accessibility can be a major problem, failing to meet enrollment rates in clinical trials. But clinical trial automation can help reverse these issues.  

Automation can improve the patient experience by reducing variables in clinical trial processes. Moreover, automation allows remote data reporting, making protocol adherence easier for participants and reducing clinical trial expenses. It lowers participant dropout rates by consistently reporting and receiving information. 

RPA can sort and analyze data to alert clinicians of detected anomalies from heart monitors and other wearable devices. That way, doctors can remotely check and advise the patient on the best next steps. The same principle applies in clinical trial settings. Patients don’t have to travel far and can conveniently send their data for the clinical trial. 

Conclusion 

Clinical trial automation promotes more seamless trial studies, helping researchers focus more on advancing their practice. By doing so, they can attend to the needs of the patient subjects, make keener result observations, and create more accurate and relevant findings for the success of clinical trials.