Friday 9 June 2023

Revolutionizing Clinical Trial Operations: How Digital Solutions Drive Compliance and Streamline Processes


Clinical trials can be slow and expensive. But there is a good reason for this: The results may affect many people’s lives, and any mistake can be catastrophic. As a result, clinical trials are often human-centric, which has a wide range of problems even though the process is noble. Clinical trials are often plagued with redundant and repetitive processes, poor communication, and ineffective enrollment protocol. Digital technology can help maintain the integrity of the process while streamlining many avenues of the approach.


By Aaron Smith


Main Problems Faced In Clinical Trials

Studies show that just 10% of clinical trials progress to large-scale drug production. Many experts in the field agree that outdated management and planning of clinical trials are a big part of this outcome. Due to the slow process, many tests are behind schedule, increasing the cost even further. Here are additional problems technology can help solve.


     Data scattered across systems, tools, platforms, and institutions

     Paper-based records create a logistical nightmare

     The process is time-consuming

     Poor communication between chemists and analysts

     Slow delivery of lab results and analysis delay

     Human error



Most Life Science companies seek solutions that allow them to start small and expand. They are looking for a solution that can address the needs of the sponsors at a particular time without spending too much time or resources. Systems whose core logic and functionality can be changed and adjusted based on findings, progress, or needs. Most importantly, technology can help create an easy-to-use process, cutting down on training needs and manpower requirements and helping eliminate human error.


CRMs, cloud-based solutions, automation, AI, sensors and wearables, cybersecurity, and Big Data are prime starting points in implementing technology in clinical trial site management.

Electronic Data Capture (EDC) And Electronic Trial Master Files (eTMFs)

EDCs and eTMFs are technology-driven solutions developed to replace paper-based documentation. Even though they can be and should be used concurrently, they play different roles.


EDCs are used in data collection. The software helps streamline communication between monitors, data managers, and coordinators. The software facilitates quick data study. ECDs are easy to use. All you need to do is create a form, send it out to be filled out, and solve the queries thereafter. All of this can be done in real-time, increasing transparency, reducing time, and reducing human error.


On the other hand, eTMFs are used in the structured electrical storage of data making it easier to access, update, and audit. Storing documents in this way helps speed up the process as auditors can easily see if the clinical trials comply with Good Clinical Practice (GCP) and offer a go-ahead.

Use Of AI In Clinical Trials

AI is quickly changing and improving how we do things. One area that should see a wide range of applications is clinical trials. AI can be used to improve efficiency and accuracy. It can help reduce human error by taking over redundant and repetitive tasks like data entry.


Patient recruitment is an excellent way to use AI effectively in clinical trials. Patient recruitment is perhaps the process's most time-consuming, repetitive, and psychologically draining exercise. This is because patient recruitment involves analyzing large data sets and narrowing them down to identify potential candidates.


AI can also use previous data to help identify candidate patterns, correlations, and further insights, helping determine who is most likely to stay and complete the trial process. Past data can further be used to predict the trial outcome and create a hypothesis. It helps identify promising approaches to aid decision-making and risk management. The results can help show if the clinical trial is viable before commencing or dedicating additional resources and time to the exercise.


Real-time data analysis using AI could provide vital insight into identifying abnormalities and deviations leading to immediate corrections. Quick and real-time data analysis can increase safety as any issue can be identified before it escalates. It can further maintain the integrity of the trial due to real-time unaltered updates.

Use Of Blockchain In Clinical Trials

Blockchain technology is often associated with cryptocurrency. However, the technology is expansive and adaptable, able to be used in different niches. This digital distribution ledger can make information readily available, reducing the need for clinical trials starting from scratch. Instead, the life science company can access a plethora of past trial information to create a hypothesis that can help speed up research.


One of the main advantages of using a blockchain is transparency. Any data stored on the digital ledger cannot be changed or altered unless all parties involved come to a consensus. This measure aids in not only transparency but also security.


Many clinical trial candidates back out of the exercise because of their little control over the process. Patients can take back control by allowing access to who can view their info, who can access it, and how their data can be used. More control can help encourage more participants, leading to a more extensive data pool and better, more accurate results.


On the other hand, using the blockchain can help with traceability. Many clinical trial companies quickly lose track of participants after trials are complete. They do not have sufficient long-term records of the effects of the drug, which could present future problems. The blockchain can streamline this process, from surveys, and data collection, to patient use and future drug effects.


Final Thoughts

Technology can help transform clinical trials by streamlining the process, resulting in fewer human errors and less time wastage. Such changes can help accelerate processes and make them more accurate.


The result? Better, more effective drugs and more information about different ailments and their needs. Technology use in clinical trials could help save lives and transform health care.


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