Clinical research involves a lot of documentation, such as study protocols, consent forms, study reports, and regulatory submissions. Healthcare and life sciences organizations find it challenging to manage all this manually, especially when they have time constraints and productivity demands. Therefore, it is crucial to have efficient solutions that can streamline and automate the document management processes.

Regulatory compliance is essential in clinical research, requiring accurate and compliant documentation to meet regulatory standards and guidelines. As research projects become more complex and larger in scope, scalable and adaptable solutions are necessary to manage the increasing volumes of documents effectively.

WinWire’s Clinical Document Automation Solution

WinWire’s Clinical Document Automation (WinCDA) Solution leverages Generative AI and natural language generation (NLG) to revolutionize drug development. By streamlining the creation and review of clinical trial documents, our platform speeds up time-to-market for new drugs and significantly reduces the risk of human error.

The solution generates documents like informed consent forms and clinical study reports that comply with regulatory standards set by the FDA, EMA, and ICH, ensuring that users meet regulatory requirements. Additionally, WinCDA comes with features such as document comparison for tracking changes and version control, which help to support regulatory compliance.

Key Features

· Enhanced Accuracy and Compliance Assurance

Detects errors, inconsistencies, and deviations from regulatory standards that human reviewers mistakenly overlook.

· Faster Review Cycles and Time Savings

Document review times are significantly reduced. This improved efficiency leads to shorter lead times for launching clinical trials and bringing new drugs to market.

· 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.

· Faster Approvals

Minimize review cycles with automation that generates formatted documents, reducing errors and the need for extensive edits.

Business Value

• Clinical Study Report (CSR) – Reduces the time required for CSR report writing, allowing for faster and more efficient documentation processes.
• Clinical Trial Narrative – Effortlessly generate tables and narratives for patient safety, enhancing accuracy and efficiency in reporting.
• Protocol Summarization – Achieve comprehensive and precise summaries effortlessly, saving time and ensuring consistency.
• Summary Clinical Safety – Automate the creation of module summaries, ensuring consistent and precise safety data reporting.