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Data Management

Expert Clinical Data Management Services: Ensuring Data Integrity and Speed

The success of any clinical trial—and the eventual approval of a therapy—rests entirely on the quality and reliability of its data. Our dedicated clinical data management services provide the foundation for scientifically sound, regulatory-compliant, and submission-ready results. We manage the entire data lifecycle, from initial design to final database lock, ensuring maximum data integrity and rapid delivery.

As an integrated global Clinical Research Organization (CRO), we offer a bespoke service that is both technology-forward and driven by the deep expertise of our global team of Certified Clinical Data Managers (CCDM) and highly specialized programmers.

1.Advanced Technology and Clinical Data Capture

We leverage industry-leading platforms and proprietary expertise to establish a seamless and secure environment for clinical data capture from multiple sources.

Electronic Data Capture (EDC) for Clinical Trials

We specialize in the design, build, and implementation of cutting-edge EDC clinical trials systems. Our approach focuses on user experience and efficiency for site personnel, which in turn leads to higher-quality data collected faster.

  • System Agnosticism and Medidata Expertise: While we are proficient across all major platforms, we are a recognized partner with industry leaders like Medidata. Crucially, our team includes in-house Medidata programmers capable of programming custom functions and complexed forms and reports—including custom edit checks, sophisticated integrations, and dynamic workflow automations—to perfectly match the unique complexity of your protocol.

eSource and Decentralized Trial Integration: We excel at integrating data from non-EDC sources, such as central labs, medical imaging, ePRO (electronic Patient Reported Outcomes), wearable sensors, and Electronic Health Records (EHRs). This multi-source integration is managed within our validated clinical data management system to provide a complete, unified view of the patient’s data in real-time.

2. Rigorous Data Quality and Validation Processes

Our core objective is to deliver a final dataset that is complete, consistent, and accurate. We achieve this through a process of continuous, real-time quality assurance that minimizes rework and accelerates timelines.

  • Data Validation Programming: Our data validation process is rooted in a detailed Data Validation Specifications (DVS) and edit check specifications developed from a meticulous review of your protocol. We program complex automated checks into the clinical data capture system to flag discrepancies, inconsistencies, and protocol violations the moment they occur.
  • Query Management and Resolution: Discrepancies identified by the system or during manual data review are immediately routed to the site personnel via a query workflow. Our data managers expertly manage this query resolution process, tracking metrics such as query response time and closure rate, to ensure a swift path toward clean data.

Medical and Serious Adverse Event (SAE) Coding and Reconciliation: We use industry-standard dictionaries (MedDRA and WHODrug) to accurately code all adverse events, medical history terms, and concomitant medications, ensuring standardized reporting across all sites. This is followed by a stringent reconciliation process to align the safety data in the PV system with the efficacy data in the clinical data management system

3. Standardization and Regulatory Compliance

Compliance with global standards is non-negotiable and is foundational to accelerating your regulatory submission.

  • CDISC Standards Implementation: We ensure your trial data is aligned with CDISC standards (Clinical Data Interchange Standards Consortium), utilizing CDASH (for data collection) and SDTM (Study Data Tabulation Model) for submission. This standardization creates a clear, predictable path for regulatory review (e.g., FDA, EMA) and is critical for ensuring data integrity and traceability from the source data to the final statistical analysis.

Process Documentation and Audit Trails: All data management activities are performed in adherence to our robust Standard Operating Procedures (SOPs) and are fully compliant with Good Clinical Practice (GCP) and 21 CFR Part 11 requirements. Comprehensive audit trails track every data change, query, and user access, providing an immutable record that demonstrates data integrity to regulators.

4. Final Data Deliverable and Database Lock

The ultimate goal of clinical data management is the timely database lock (DBL), a major milestone that officially concludes data collection and cleaning.

  • Pre-Lock Readiness: Before DBL, our Data Management, Biostatistics, and Clinical Operations teams conduct final, comprehensive data review activities. This includes ensuring all data is entered, all external data is reconciled, all queries are resolved and closed, and all required approvals from key stakeholders are secured.
  • Accelerated Database Lock: By performing continuous data cleaning throughout the study, we drastically reduce the time needed between the last patient’s last visit and the final database lock. The locked database—a final, frozen dataset—is then handed over to the Biostatistics team for final analysis, paving the way for the Clinical Study Report (CSR) and eventual submission.

Our commitment to quality, combined with our deep technical expertise and global reach, positions us as your essential partner for high-stakes clinical data management. We turn complex, multi-source data into reliable evidence that drives successful health outcomes.