As the clinical research field continues to evolve, ensuring that trial data is accurate, complete, and dependable is key to achieving successful outcomes. At Amarex, our Data Management (DM) team is dedicated to ensuring the highest quality data through proactive data review and effective edit check strategies.

Importance of effective edit checks

Edit checks are an essential element of data quality assurance in clinical trials. They allow us to identify discrepancies, inconsistencies, or missing information quickly and efficiently. By catching these issues early, we not only save time and costs but also strengthen the integrity of the final dataset submitted for regulatory review.

Purposeful edit check design

At Amarex, we take a proactive, focused approach to edit check development and implementation. This means our processes go beyond basic system checks, with key components that include:

• Prioritization of critical checks: We focus first on safety and efficacy endpoint related data checks.
• Standardized libraries: We leverage both system and external edit check libraries and follow best practices while tailoring checks to the unique needs of each protocol. These libraries allow for reuse of validated logic, reduce programming time and help maintain quality standards.
• Collaborative process: Our data managers partner with biostatistics, clinical operations, and sponsors to develop edit checks that are customized to align with the unique objectives and outcome measures of each study.
• Efficiency & precision: Automated system checks are balanced with externally programmed checks. At Amarex, we also leverage programmed checks to assist with manual data review to ensure no important detail is overlooked.
• Ongoing review and optimization: Our attention to detail in creating valuable, effective edit checks is utilized throughout the life of the study. During our ongoing review process, we remove or adjust checks that generate excessive invalid output and add new checks as needed, based on data issue trends identified during study maintenance.

At Amarex, our well-structured edit check process provides meaningful advantages for sponsors and partners:

• Accelerated database lock timelines by reducing the number of late-stage data issues.
• Cost savings through fewer re-runs and avoiding non-essential and unnecessary queries to sites
• Regulatory confidence by ensuring datasets are clean, accurate, and submission-ready.
• Patient Safety: Ensuring accurate clinical data is critical to the effective monitoring of adverse events and safety assessments.

Setting a higher standard in data management

By combining advanced technology with the expertise of our dedicated CDM team, Amarex sets a higher standard for data quality. We believe that effective edit checks are not just a process step, but the foundation of clinical trial success.

Amarex understands the critical balance between efficiency and accuracy, and will deliver reliable data that is ready for regulatory submission.