Best Practices for Biostatisticians: Preparing for Interim Analysis in Clinical Trials
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In today's intricate clinical trial environment, where data sources extend beyond conventional EDC systems, ensuring data quality, harmonization, and effective management is ever-present. Precision’s clinical data management team champions a unified approach, emphasizing proactive data cleaning to uphold data integrity and offering bespoke strategies tailored to unique sponsor needs.
With a particular focus on complex oncology and rare disease trials, we meticulously map the clinical data landscape for each study, ensuring integrity and reliability. Our commitment to proactivity, quality and speed facilitates quicker decision-making, accelerating the path to trial conclusions and potential market entry. At Precision, delivering on our name through precise execution is not just our promise; it's our practice, ensuring your study's success from start to finish.
Our expertise spans across various EDC systems, ensuring compatibility and seamless integration with your preferred platforms. Whether under Full-Service Outsourcing (FSO) or Functional Service Provider (FSP) models for clinical data management, our approach is always aligned with your technology and study needs.
Need help selecting the right EDC? Our experts can help align the right technology with your study's unique demands.
Below is our current list of supported EDC systems pending the outsourcing model you desire for:
Our suite of clinical data management outsourcing solutions is designed to provide flexibility and scalability, ensuring you receive support that's precisely aligned with your project and organizational requirements. Whether you're looking for comprehensive service or targeted support, we have a solution to fit your needs.
In the world of oncology trials, Precision’s clinical data management team not only manages the daunting volume and complexity of data but transforms it into strategic advantage.
Serving as diligent data brokers, we ensure the integrity and quality of your data, while our suite of tools including a comprehensive library of preconfigured CRF designs and edit checks, automated review listings, and visual patient profiles, enhances efficiency from EDC build to in-depth analysis. This dual approach expedites database lock and amplifies the strategic value of your data, making navigating oncology trials with Precision both easier and more effective.
270+ preconfigured CRF design and edit checks library
Automated clinical data review listings for 50+ manual checks
Oncology risk library (RACT)
Visual patient profiles with RECIST endpoints
Driving actionable insights with dynamic data visualization, backed by powerful analytics capabilities with Clarity. Clarity centralizes trial intelligence through multiple data-driven lenses to help surface insights at patient, site, and study levels. Designed to simplify risk and oversight throughout clinical development enabling timely decision-making and stronger patient outcomes.
In addition to clinical intelligence, Clarity RBQM enables the management of all quality parameters throughout clinical development. Built on ICH GCP E6R2 principles, this module helps define and guide the entire risk and quality management process from planning to cross-functional review, reporting and remediation.
Centralized Monitoring at Precision for Medicine leverages specialized oncology expertise and advanced data visualization tools to enhance clinical trial data quality.
By integrating a cross-functional approach to data review, this team delivers real-time, actionable insights, ensuring data integrity and supporting informed decision-making. This strategic focus on data quality not only streamlines trial processes but also accelerates the path to drug development success, underscoring Precision's commitment to pioneering advancements in healthcare through superior data analysis and interpretation.
Stay updated with the latest insights in clinical data management and clinical research through our blog.
Leverage an integrated infrastructure that reduces the inefficiencies inherent in complex development. Integrate lab and trial execution to increase speed to market. Incorporate manufacturing expertise for advances therapies to ensure scalability. Precision can customize and converge our capabilities for your program's unique needs.
Award-winning CRO with deep oncology and rare disease expertise
Exceptional translational and biomarker sciences with global central lab services
Pioneers in planning, building and maintaining manufacturing at scale for pharma and biotechs.
Contact us to learn more about how Precision for Medicine can partner with you to drive your clinical trials forward.