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Automated Quality Control: Get the best out of your Clinical Study Report Review 

What are Clinical Study Reports? 

Clinical study reports (CSRs) are critical documents that summarize the results and findings of clinical trials. The different sections of CSR provide a comprehensive overview of the clinical trials and its results and serves as a record for further documentation and communication of the trial findings to the regulatory authorities, sponsors and other stakeholders. 

Reason for Quality Control in CSR 

The structure and content of a CSR may vary depending on the specific guidelines provided by regulatory authorities, but researchers and sponsors should adhere to the applicable guidelines when preparing a CSR to ensure regulatory compliance and transparency.  

To attain these guidelines, thorough review of CSR is mandatory before submission to regulatory authorities. Historically, performing quality control on CSR requires approximately 40 working hours. But introduction of automation has reduced the manual time, and human efforts to review CSR.  

Conducting a Clinical Study Report Review 

Conducting a thorough review of CSRs is essential to ensure the accuracy, integrity, and compliance of clinical trial data. However, manual review processes can be time-consuming, resource-intensive, and prone to human error. To address these challenges, automated quality control systems are emerging as valuable tools to streamline CSR review processes and optimize the efficiency and effectiveness of clinical research.  

How can you enhance the efficiency of your CSR within minimal time? 

CSR review, involving the careful assessment of numerous documents, data tables, and statistical analyses, through automation can save a lot of time for the reviewers. The 40 hours required to review different artifacts of CSR, can now be done within 4 hours through reports generated by Automation Tools. Automated quality control tools automate key aspects of the review process, significantly reducing the time and effort required.  

Can you tell how consistent and accurate CSR can be through automated quality control? 

Maintaining consistency and accuracy in CSR is crucial for ensuring accurate and reliable evaluations. Different reviewers might interpret evaluation criteria differently, leading to subjective assessments. But automated quality control systems can enforce predefined standards and criteria consistently, ensuring a fair and objective evaluation process.  

Accurate and reliable data is paramount to the integrity of clinical study reports. Manual review processes are often prone to human errors. And automated quality control systems can analyse large volumes of data efficiently, identifying discrepancies, outliers, and anomalies. By flagging potential data inconsistencies, these systems help ensure the accuracy and completeness of the CSR.  

Let’s analyse these Data Insights 

Automated quality control systems offer advanced data analysis capabilities, enabling researchers to extract valuable insights from clinical trial data. With patterns, trends, and correlations within the data, automation can facilitate a deeper understanding of study outcomes. Also, with visual interpretation of clinical data, it is much easier to see flagged inconsistencies, and make better and informed decisions. 

Want to know how Geninvo is providing innovation to these inconsistencies? 

Geninvo has been in the industry providing rich experience and bringing innovation to life. With unique combination of expertise in Life Sciences, leading-edge technologies, and software development, we bring a unique problem-solving approach in automating the Life Sciences industry. 

Hours of manual review can be done by DocQC in just 4 working hours. DocQC not only checks for the presence of cited references, but also reports the accuracy of the data and flags the discrepancies, outliers or anomalies. Discrepancies, which you can validate in real time or at a later stage using Offline Reports. 

Great news! It still doesn’t end; you can also provide your review comments or update the CSR inside DocQC and download the upgraded version of your CSR or share with your team. Integrating DocQC, you can get your final draft of CSR with such ease within such a short period of time. 

Now, what tasks can medical reviewers perform? 

To answer this question, let’s look at the critical thinking medical reviewers bring to the study reports. DocQC can generate the discrepancies or outliers, summarising the report for medical reviewers to make better decisions based on the visual reports. DocQC and critical thinking by medical reviewers, can revolutionize the medical industry.  

While DocQC can serve as a valuable tool to generate the findings, the judgement and expertise of human reviewers still remain a crucial aspect in the completion of the CSR. Reviewers can now spend more time on evaluating critical relevance and interpretation of data, for better critical judgements, as per their expertise and experience. 

Automated quality control systems present significant advantages in the realm of clinical study report reviews. By streamlining processes, ensuring consistency, and enhancing data accuracy, these systems optimize the efficiency and effectiveness of CSR evaluations. As the demand for robust clinical research continues to grow, leveraging automated quality control systems can help researchers, sponsors, and regulatory authorities achieve reliable, compliant, and high-quality clinical study reports. 

By Hargun Kaur Sethi 
Software Development and Business Growth, GENINVO

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