Clinical Study Report (CSR)

Accelerate CSR Creation, Improve Accuracy, and Ensure Regulatory Compliance

Beseek streamlines the CSR process by intelligently extracting and organizing data from clinical trial documents, protocols, and patient records. Quickly identify key findings, adverse events, and statistical summaries.

Generating Clinical Study Reports (CSRs) is a complex and time-consuming undertaking, involving vast amounts of data from multiple sources. Ensuring accuracy and meeting regulatory deadlines is critical.

Data Deluge

CSRs require integrating data from a multitude of sources, including clinical trial databases, electronic data capture (EDC) systems, lab results, patient records, statistical analyses, and investigator brochures. Managing this vast amount of data is a logistical nightmare.

Manual Data Wrangling

Traditionally, much of the data extraction, cleaning, and analysis is done manually. This is incredibly time-consuming, prone to errors, and requires significant resources.

Time Pressure

Delays in CSR completion can significantly impact drug development timelines and market entry, leading to lost revenue and competitive disadvantages.

Collaboration Complexity

CSR creation involves input from various teams (clinical operations, biostatistics, medical writing, regulatory affairs), making collaboration and version control a major challenge.

Stringent Regulatory Requirements

CSRs must adhere to strict regulatory guidelines (e.g., ICH E3), which dictate the format, content, and level of detail required. Non-compliance can lead to costly delays in drug approval.

Document Intelligence Platform

Transform Your CSR Workflow

Beseek provides a powerful, streamlined solution for CSR creation, designed to address the specific challenges faced by clinical research organizations.

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Data Aggregation & Integration

Beseek seamlessly connects to various data sources, including EDC systems, clinical trial databases, lab results, and even unstructured data like patient narratives. It automatically extracts and consolidates relevant data, eliminating the need for manual data entry and reducing the risk of errors.

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Workflow Automation & Collaboration

Manage the entire CSR process from start to finish with Beseek’s built-in workflow tools. Assign tasks, track progress, manage deadlines, and collaborate seamlessly with team members. Version control ensures everyone is working with the most up-to-date information.

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Accuracy Verification & Validation

Reduce the risk of human error with Beseek’s automated data extraction and analysis capabilities. The platform automatically verifies data against predefined rules and flags potential inconsistencies, ensuring the accuracy and integrity of your CSR.

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Statistical Analysis & Reporting

Perform complex statistical analyses with ease. Beseek can automatically generate tables, figures, and listings that meet regulatory requirements. Identify key trends and statistically significant findings quickly and efficiently.

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Template-Based Workflows & Reporting

Utilize pre-built templates that adhere to industry best practices and regulatory guidelines (e.g., ICH E3), or create your own custom workflows to meet specific study requirements. Generate reports in various formats, including those required for regulatory submissions.

From Data Chaos to Actionable Insights

Don’t let the complexity of CSR creation slow down your clinical research. Schedule a live demo to see how Beseek can help you create accurate, compliant CSRs faster, more efficiently, and with greater confidence. Experience the difference that intelligent automation can make.

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