End-to-End Clinical Data Management Solutions

We provide comprehensive Clinical Data Management (CDM) Services to ensure the integrity, accuracy, and regulatory compliance of clinical trial data. Our qualified CDM team manages the entire data lifecycle - from database design and eCRF build through data cleaning, medical coding, and database lock.

We offer end-to-end expertise in Clinical Data Management, supporting pharmaceutical, biotechnology, and CRO clients in delivering high-quality, regulatory-ready clinical trial data across all phases of development.

Based in Singapore, we serve clients across Asia-Pacific and beyond, applying deep knowledge of ICH E6(R3) GCP, CDISC standards, and regional regulatory requirements to every study we manage.

Our Clinical Data Management Services

Comprehensive CDM solutions designed to ensure data quality and regulatory compliance throughout your clinical trial

Database Design and Build

Design and build clinical databases that capture all data points defined in the study protocol. We develop robust, validated databases that support data integrity, regulatory compliance, and efficient data entry tailored to each study's requirements.

eCRF Design and Build

Design and build electronic Case Report Forms (eCRFs) aligned with the study protocol and data collection requirements. Our eCRF designs are user-friendly, protocol-compliant, and structured to minimize data entry errors and query burden.

Data Cleaning and Validation

Systematic review and validation of clinical trial data to ensure completeness, accuracy, and consistency. Our data cleaning processes apply protocol-specific edit checks and validation rules to identify and resolve data discrepancies efficiently.

Data Query Management

Efficient generation, tracking, and resolution of data queries to address discrepancies and data issues. We manage the full query lifecycle - from issuance and site follow-up through resolution and closure - maintaining accurate audit trails throughout.

Data Transfer and Reconciliation

Secure transfer and reconciliation of clinical data between systems and vendors - including external data streams such as central lab, ECG, PK, and PRO data. We ensure data completeness, accuracy, and traceability at every transfer point.

Medical Coding

Application of standardized coding dictionaries for accurate classification of adverse events, medical history, concomitant medications, and indication terms. We code using the latest versions of MedDRA and WHODrug, ensuring consistency and regulatory alignment.

Data Management Plan (DMP) Development

Preparation of comprehensive Data Management Plans that define CDM processes, roles, timelines, and quality standards for each study. Our DMPs align with ICH E6(R3) GCP and sponsor SOPs to establish a clear framework for data management activities.

Edit Checks Programming

Development and validation of programmatic edit checks to automate data consistency and range validations. Our edit check specifications and programs are documented, tested, and validated to ICH and sponsor standards, reducing manual review burden and improving data quality.

CDISC Standards (CDASH / SDTM)

Implementation of CDISC standards including CDASH for data collection and SDTM for regulatory submission. We ensure your clinical data is structured in full compliance with CDISC and FDA/EMA submission requirements, facilitating seamless regulatory review.

External Data Vendor Management

Coordination and oversight of external data vendors supplying central laboratory, imaging, PK, ePRO, wearable, and other third-party data streams. We manage data specifications, transfer agreements, and reconciliation to ensure complete and timely data integration.

Database Lock and Archival

Management of all activities required for database lock, including final data review, discrepancy resolution, blind review, and formal lock procedures. Following lock, we support secure archival of clinical data and documentation in compliance with regulatory retention requirements.

CDM System Validation

Validation of clinical data management systems and tools in line with 21 CFR Part 11, GxP, and GAMP5 guidelines. We provide validation documentation, IQ/OQ/PQ protocols, and ongoing system change control support to maintain a compliant validated state.

Why Choose iPharmX for Clinical Data Management?

Expert CDM solutions with a commitment to data quality, regulatory compliance, and operational excellence

Qualified CDM Expertise

Our CDM team brings extensive hands-on experience across all phases of clinical trials, applying industry best practices and regulatory standards to deliver high-quality data management services.

Data Integrity Focus

We apply rigorous data cleaning, validation, and quality control processes to ensure your clinical trial data is accurate, complete, and audit-ready meeting the highest standards of data integrity throughout the study lifecycle.

Regulatory Compliance

We follow ICH E6(R3) GCP, 21 CFR Part 11, CDISC standards, and regional regulatory requirements, ensuring that all CDM activities are fully compliant and ready for regulatory submission and inspection.

Technology Platforms We Support

Medidata Rave

Oracle InForm

Veeva Vault EDC

REDCap

Ready to Optimise Your Clinical Data Management?

Contact us to discuss how our qualified CDM services can support your clinical trial data needs and regulatory compliance requirements.

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