Clinical trials need many steps before patients can join. One important step is the build phase. This means setting up trial plans, tests, schedules, and ways to collect data in electronic systems. Setting up electronic Clinical Outcomes Assessment (eCOA) has often caused delays. eCOA collects patient feedback digitally and needs careful checks to meet rules.
Before automation, setting up eCOA systems was done manually. People had to configure everything, test a lot, and do quality checks that took weeks before the trial could start. These delays are a problem because faster trials mean quicker access to new treatments. Manual work also increases chances of mistakes and lowers data quality, which can break the rules.
For managers and IT staff, these delays cause extra work and high costs. Empty trial sites and long manual tasks make trial start-up inefficient and expensive. This is why better tools that automate tough jobs and follow U.S. rules like HIPAA and FDA 21 CFR Part 11 are needed.
Medable is a company that builds smart automation tools for clinical trials. Their platform cuts the time needed to set up trial technology by half or more.
Medable automates how eCOA is set up and checked. Their auto-configuration tool creates standard trial schedules, important dates, and patient alerts in minutes instead of days or weeks. Their auto-validate tool runs quick quality tests and gives instant reports. This saves weeks of manual work.
Michelle Longmire, Medable’s CEO, says this automation removes major delays in trial start-up. Their goal is to start a study in one day, which would change how fast trials begin. This matches the needs of U.S. healthcare groups that want faster research without losing data quality or breaking rules.
Medable’s platform has shown clear results. Customers say patient enrollment is twice as fast, and costs are cut by about half. Their software also supports decentralized and hybrid trials, which became more common after COVID-19. These types of trials let patients join remotely, lowering travel and location problems.
By 2023, Medable’s platform was used in over 300 trials in 60 countries, involving over a million patients. Many top U.S. drug companies use it to reduce build times and handle complex trial setups.
AI and automation do more than speed up trial start-up. They help improve many daily tasks in healthcare research. For managers and IT teams, knowing how to use these tools is key to managing trials well and cutting down manual work.
AI helps by automating routine tasks with high accuracy. In clinical trials, these include:
Using these tools, healthcare groups reduce extra work, cut mistakes, and make trial timelines more reliable. This lets staff focus on patients and science, not paperwork.
The COVID-19 pandemic pushed many U.S. research groups to change how trials work. They needed ways for patients to join trials remotely and be monitored digitally. This led to more decentralized trials. These let patients participate using phones or local clinics. It lowers travel needs.
Platforms like Medable’s help these trials run smoothly. They link data capture, protocol checks, and patient communication in one system. The automation speeds up setup across many locations far apart.
Mohammed Ali from Medable points out that pandemic-driven changes should continue to build lasting research methods. Experts from the Tufts Center say decentralized trials can save money compared to normal trials, especially in mid and late-phase studies. The savings can be $10 million to $39 million, which helps U.S. groups manage budgets better.
Health groups in the U.S. follow strict rules to protect patient rights, data privacy, and ethical research. Using AI and automation must follow these rules to keep trust and data integrity.
Medable’s technology meets key standards like:
AI tools don’t replace regulatory checks but help improve compliance by automating documentation, validation, and record keeping. This helps trial managers get ready for audits on time and with accuracy.
Using intelligent automation in trials gives benefits beyond faster builds and lower costs. For healthcare managers and IT staff in the U.S., these tools mark a move to stronger research systems. These systems can handle tricky trials and make results better for patients.
Some key benefits are:
AI and intelligent automation tools are changing clinical trial work in the United States. They cut build times in half and change how trials start. Companies like Medable have shown success in using these tools in hundreds of trials. This leads to faster patient enrollment, cost savings, and compliance with tough rules.
For healthcare managers and IT professionals, these tools are important for running trials efficiently and speeding up new treatments. As trials get more complex and costly in the U.S., intelligent automation is likely to become a common part of research. This can help groups serve patients better and deliver new medicines faster.
Medable’s intelligent automation technology reduces clinical trial build timelines by at least 50%, notably by automating manual tasks such as testing, which historically delay the electronic clinical outcomes assessment (eCOA) deployment. This accelerates trial start-up times and eliminates key bottlenecks in trial operations.
Medable automates labor-intensive tasks including the conversion, configuration, validation, and quality engineering of clinical trial studies. The automation of testing and validation processes, especially for eCOA deployments, removes weeks of manual effort, speeding trial readiness.
Electronic Clinical Outcomes Assessment (eCOA) deployments capture patient data digitally and have traditionally caused major delays in trial startup due to complex configuration and testing requirements. Medable’s AI simplifies and accelerates this process, removing eCOA as a critical path bottleneck.
Medable’s auto-configuration tool quickly produces standard configurations, such as assessment schedules, anchor dates, and patient flags within minutes, dramatically reducing the time to create and finalize study setups that traditionally took weeks.
The auto-validate tool automatically performs comprehensive testing to generate a downloadable Configuration Validation Report (CVR), eliminating weeks of manual validation and ensuring study build quality and readiness faster than conventional methods.
Customers have observed outcomes like 200% faster patient enrollment and 50% cost reductions. This leads to significant ROI, with decentralized trials showing 5 to 13 times net financial benefits in Phase II and III studies, facilitating faster medicine development and patient access.
Medable adheres to strict ethical AI principles and regulatory standards including 21 CFR Part 11, HIPAA, GDPR, and ICH GCP, guaranteeing data quality, privacy, and compliance throughout AI-powered clinical research deployments.
Medable aims to achieve a one-day study start-up by continuing to eliminate process bottlenecks using advanced AI and automation, ultimately accelerating the delivery of effective treatments to patients faster than ever before.
Medable’s platform is deployed in over 300 decentralized and hybrid clinical trials across 60 countries, supporting more than one million patients and research participants globally, demonstrating substantial scalability and global reach.
The pandemic catalyzed creativity and momentum in clinical research, leading to sustainable, scalable digital decentralized trial models. Medable emphasizes building on these learnings to drive further cycle time reduction, cost efficiencies, and life-saving compound identification using AI.
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