Clinical Trial Data Management

Clinical Trial Data Management

At TD2, our experienced data management team includes data managers, data coordinators, clinical database programmers, and clinical data reviewers. Our data management services encompass a wide range of capabilities, ensuring your oncology trials are executed with precision and efficiency. With TD2’s comprehensive data management capabilities and expertise, we are your trusted partner, enabling you to focus on advancing your innovative therapeutics.

CRF Design Expertise: We design case report forms (CRFs) in accordance with the Clinical Data Acquisition Standards Harmonization (CDASH) standard, streamlining data collection and ensuring data consistency.

Real-Time Metrics: TD2 provides real-time clinical trial metrics, enabling proactive decision-making and trial management.

Data Quality Assurance: Our team conducts double-data entry for paper CRFs to minimize errors and maintain data accuracy.

Data Review and Query Generation: We review clinical data for errors and trends, promptly generating electronic queries for resolution.

System Validation: We meticulously validate all project-specific components of the data management system to ensure it meets your trial’s unique requirements.

Data Integration: We seamlessly integrate data from external sources, ensuring alignment and consistency with CRF data.

CDISC Compliance: We deliver a clean, analyzable database adhering to the Clinical Data Interchange Standards Consortium (CDISC) standards, promoting regulatory compliance and data consistency.

Adverse Event Reconciliation: We meticulously reconcile serious adverse events, ensuring accurate reporting and patient safety.

Platform Flexibility: Our team seamlessly operates within multiple Electronic Data Capture (EDC) platforms, accommodating your preferred tools and workflows.

“There are countless opportunities to learn and grow at TD2. From designing the eCRFs, creating therapeutic area standards, hands-on programming, exploring existing platforms and adapting new ones, to managing data throughout trials, and ensuring patient safety to produce clean data for analysis and submissions. At TD2 you explore, innovate, discover, implement, and achieve!”

– Current Sr. Data Manager

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