Streamlining Clinical Trials: A Web Application Used for Project Data Services
Clinical trials demand efficient data services to ensure accuracy, compliance and timely insights. Over the years, the way clinical trial data has been collected has transformed, with new standards being put in place. Electronic Data Capture (EDC), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM), as examples, all now provide a framework for standardized data handling.
However, integrating these structures and frameworks with third-party data and enabling rapid quality controls and analysis remains a challenge. Leveraging a powerful web application can help address integration concerns by offering seamless data importation, exploration, quality control, visualization and reporting in one place.
Read how custom-designed web application tools can transform clinical data services, supporting project teams, medical monitors, data monitoring committees (DMCs), annual reports, bioresearch monitoring (BIMO) listings, and patient profiles, all within one application.
Effortless Data Importation
The cornerstone of effective clinical data services is the ability to import and integrate diverse data sources. Web applications support EDC systems, SDTM and ADaM datasets, alongside third-party data like bioanalytical results or electronic patient-reported outcomes (ePRO). Having disparate datasets centralized in the web application allows for easier access and streamlined analysis.
Simplified Data Mining
Having the ability to evaluate and review clinical trial data with ease while also in a timely manner is critical for uncovering relevant trial insights. Web applications’ intuitive interface allows users to query datasets with minimal effort, using a unified data model (UDM) to filter and stratify variables like demographics or adverse events. Like tools like Xbiom from PointCross Life Sciences, it enables rapid cohort analysis without requiring advanced coding skills, broadening the pool of who can derive outputs from the application. Researchers can identify trends or specific patient groups with just a few clicks, fostering faster data-driven decisions and supporting translational research across studies.
Robust Quality Control and Statistics
Robust quality control (QC) measures are essential for data integrity throughout a clinical trial. Web applications can automate QC processes, generating real-time tables, listings and figures (TLFs) with a single click. Statistical summaries, including descriptive statistics are produced instantly, empowering clinical data managers (CDMs) to validate data ranges and perform edit checks. This enhanced functionality helps streamline data quality assurance, thus reducing the risk of errors during regulatory submissions.
Interactive Data Visualization
Being able to visualize data is key for enabling researched to identify outliers and observe trends. Web applications offer interactive graphs, such as scatter plots or box plots, built from SDTM domains (e.g., Laboratory Test Results) and ADaM datasets (e.g., ADLBCHEM). These visualizations help medical monitors and DMCs spot anomalies in laboratory results or vital signs quickly. Real-time updates ensure dynamic exploration, making it easier to address data issues that could impact trial outcomes or patient safety.
Reproducible Outputs and R Code
Reproducibility is critical in clinical research. Web applications allow users to save output like TLFs, statistical summaries and graphs for future reference or submissions. It also stores R scripts used for analysis, enabling biostatisticians to rerun code consistently across studies. This aligns with 21 CFR Part 11 requirements for date- and time-stamped logs, ensuring audit-ready documentation. Saved R code supports advanced statistical modeling, enhancing transparency and compliance.
Empowering Data Monitoring Committees
DMCs require efficient tools to oversee trial safety and integrity. Web applications provide DMC members with real-time access to TLFs, graphs and patient-level data through an intuitive dashboard. By leveraging standardized SDTM and ADaM datasets, it ensures analysis-ready data for interim reviews.
Rapid BIMO Listings
BIMO listings are vital for FDA inspections, detailing trial conduct and compliance. These web applications generate these listings in minutes, pulling data from SDTM domains like disposition or protocol deviations. Automation ensures accuracy and consistency, aligning with the FDA’s Data Standards Catalog. This functionality within the application saves data managers time and facilitates smoother regulatory reviews, reducing the burden of manual preparation.
Comprehensive Patient Profiles
Enhanced patient profiles provide a detailed view of individual patient data, crucial for medical monitors and submissions. Web applications can integrate datasets (e.g., adverse events) to generate customizable profiles. These can be used for real-time safety monitoring or regulatory submissions, enabling rapid identification of protocol deviations or safety concerns. The on-demand generation made possible through the application enhances clinical oversight and compliance.
A Powerful Clinical Data Solution for Better Clinical Data Management
Partnering with Actalent to design and develop a web application for clinical data solutions can help to simplify the complexities of clinical trial data management. Designed to align with Clinical Data Interchange Standards Consortium (CDISC) standards, we’re able to help you create an application that integrates EDC, SDTM, ADaM and third-party data, streamlining workflows for pharmaceutical companies, Contract Research Organizations (CROs) and biotech firms.
By helping to create a user-friendly, all-in-one web application solution, Actalent can empower clients to manage data efficiently, ensure regulatory compliance and accelerate trial timelines. These customized platforms support diverse stakeholders, including CDMs, biostatisticians, medical monitors and DMCs, enhancing collaboration and decision-making.
Advancing Clinical Reseach and Patient Outcomes
Custom web applications are revolutionizing clinical data services by integrating data importation, exploration, QC, visualization and reporting. Supporting CDISC standards and third-party data, they streamline workflows for researchers, CDMs, biometrics, DMCs and regulatory teams. Features like rapid TLFs, BIMO listings, patient profiles and reproducible R code ensure compliance and efficiency. By simplifying complex processes, these web applications enhance data-driven decision-making, ultimately helping to advance clinical research and patient outcomes.
Frequently Asked Questions About Web Applications
Used for Project Data Services in Clinical Trials
For the web application to be successful, you’ll need a secure platform infrastructure like POSIT Connect or Shiny Server. Open-source hosting options like Shiny Server can reduce costs but may require additional configuration for regulatory compliance. Costs would also be associated with the initial setup and validation and possible annual maintenance, but pricing would be based on the customized options you select.
R and R-Shiny are free, open-source tools, which significantly reduce licensing costs. Existing open-source frameworks like teal (an R-Shiny framework for clinical data exploration) can serve as a starting point, minimizing development time. However, building a custom application requires skilled R developers to design and implement features like data importation (EDC, SDTM, ADaM, third-party data), interactive dashboards and standard outputs (TLFs, BIMO listings, patient profiles).
Seeking Clinical Development Services?
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