Clinical trials generate vast amounts of complex, unstructured protocol documents, including study designs, methodologies, and informed consent forms. Cleaning, organizing, and manually reviewing these documents is time-consuming and challenging for healthcare and pharmaceutical organizations.

For organizations, there is a pressing need for an efficient and accurate solution to streamline the review process of clinical trial protocol documents and ensure that these protocols are error-free and compliant with regulatory requirements.

WinWire’s Generative AI-based Drug Trials Protocol Review Solution

The solution employs advanced natural language processing (NLP) techniques and machine learning models to analyze clinical trial protocol documents meticulously and is designed to be adaptable to various regulatory frameworks and guidelines governing clinical trials.

The solution is adaptable to various regulatory frameworks and guidelines governing clinical trials. It incorporates a knowledge base of international and regional regulatory standards, including those set by the FDA, EMA, and ICH.

1. Enhanced Accuracy & Compliance Assurance: The solution detects errors, inconsistencies, and deviations from regulatory standards that human reviewers might overlook. By flagging potential issues in real-time, the solution ensures that clinical trial protocols are thoroughly vetted for compliance with regulatory guidelines.

2. Faster Review Cycles and Time Savings: Manual review of clinical trial documents can be time-consuming, often requiring weeks or even months to complete. With the Generative AI solution, document review times are significantly reduced. This efficiency leads to shorter lead times for launching clinical trials and bringing new drugs to market.

3. Improved Risk Mitigation and Patient Safety: Identifies potential safety concerns or ethical issues within clinical trial protocols. It can cross-reference historical data, adverse event reports, and best practices to ensure that patient safety is a top priority.

Business Value

1. Efficiency and Time Savings: Automating document analysis, error detection, and compliance checks significantly reduces review cycle times.

2. Accuracy and Compliance Assurance: Enhances the accuracy of clinical trial protocol evaluations. It detects errors, inconsistencies, and deviations from regulatory standards, minimizing the risk of protocol rejection.

3. Risk Mitigation and Patient Safety: Mitigates risks associated with clinical trials and elevates patient safety.

Deliverables

· Document Review Reports

· Customized Compliance Checklists

· Automated Documentation