At CLINZTECH, our Clinical Data Management (CDM) team plays a pivotal role in ensuring the accuracy, integrity, and reliability of clinical trial data. We assist our clients in maximizing the value of data generated throughout the clinical trial process—whether using traditional paper-based methods or Electronic Data Capture (EDC) systems—to enhance operational efficiency, reduce development costs, and minimize risks for both study participants and sponsors. We cater to a wide range of studies, from small-scale rare disease trials to large-scale global programs.

Key Differentiators

• Global Expertise: A diverse and experienced team of clinical data managers and statistical programmers with global exposure.
• Innovative Technology: Use of proprietary and advanced technologies to ensure real-time, high-quality data delivery.
• Regulatory Excellence: Compliance with global regulatory requirements (FDA, EMA, ICH-GCP), facilitating successful submissions and approvals.
• Flexible Operational Models: Whether following client-specific SOPs or CLINZTECH SOPs, our operations are adaptable and collaborative.

Comprehensive Clinical Data Management Services

Database Design and Customization

• Development of tailor-made databases as per sponsor-specific protocols and requirements.
• Support for multiple EDC platforms such as Medidata Rave, Oracle InForm, and OpenClinica.

Project Transition & Lifecycle Management

• Seamless transition of ongoing projects from Study Start-Up to Close-Out Phase.
• Full End-to-End Study Lifecycle support ensuring consistency and traceability.

CRF Development and Validation

• CRF (Case Report Form) Design, compliant with study protocols and data standards.
• CRF Annotation following CDASH/CDISC guidelines.
• CRF Tracking throughout the data collection period.

Edit Check Programming and Testing

• Design and implementation of both automated and manual edit checks.
• Rigorous edit check testing and User Acceptance Testing (UAT) for validation.

Data Capture and Review

• Efficient data entry (for paper-based studies) and continuous data cleaning.
• Discrepancy management through query resolution cycles.
• Real-time monitoring of data trends and anomalies.

Safety and Lab Data Management

• Serious Adverse Event (SAE) reconciliation to ensure consistency with safety databases.
• Lab data reconciliation to identify discrepancies between central/local lab data.
• Integration of third-party vendor data (e.g., ECG, imaging, biomarkers).

Conduct Phase Activities

• Comprehensive study conduct support, ensuring all data flows are monitored and documented.
• Close collaboration with clinical operations and biostatistics teams.

Database Lock and Submission Readiness

• Thorough quality control (QC) procedures—both internal and external.
• Preparation for and execution of database lock, ensuring all data is clean, complete, and submission-ready.
• Full support for regulatory submission datasets (SDTM/ADaM), metadata, and reviewer guides.

Data Standards and System Support

• Metadata Repository (MDR) and Statistical Computing Environment (SCE) support and standardization.
• Adherence to CDISC standards (CDASH, SDTM, ADaM).
• Ongoing support for data standard governance and implementation.

Why Choose CLINZTECH for CDM?

• Client-Centric Approach: We prioritize minimal sponsor oversight while delivering consistent, high-quality outputs.
• Robust Infrastructure: Secure, scalable systems and technologies compliant with 21 CFR Part 11.
• Experienced Team: Staffed with certified professionals in CDM, EDC systems, and statistical programming.
• Audit Ready: All deliverables are audit-ready and align with regulatory authority expectations.

Let CLINZTECH be your trusted partner in delivering clean, validated, and regulatory-compliant clinical data—helping you accelerate timelines and improve decision-making.