Clinical Data Management
End-to-end clinical data management services ensuring the highest levels of data integrity, regulatory compliance, and submission readiness. From CRF design and database build through medical coding, data cleaning, and database lock — we deliver clean, audit-ready datasets that accelerate your path to regulatory approval.
Expert Data Management for Every Phase
MTK Pharma Services delivers comprehensive clinical data management solutions backed by a team with 15–20 years of deep domain expertise across all therapeutic areas and study phases. Our CDM professionals combine rigorous process discipline with an intimate understanding of regulatory expectations to ensure your clinical data meets the highest standards of quality and compliance.
From CDISC-compliant CRF design and robust database builds through meticulous medical coding, real-time data cleaning, and seamless database lock procedures, we manage the full data lifecycle. Whether you need a dedicated project team, embedded FSP resources, or a hybrid engagement model, MTK provides the expertise and scalability to support your programme from first patient in through regulatory submission.
Comprehensive Data Management Services
Eight integrated capability areas covering the full clinical data management lifecycle, from protocol-driven CRF design through database lock and regulatory archival.
CRF Design & Development
eCRF design aligned with protocol requirements, CDASH standards, and therapeutic area conventions. Optimised for data quality and site usability from day one.
Database Build & Validation
End-to-end database design, build, and UAT with comprehensive edit check programming, validation testing, and protocol amendment management.
Medical Coding
MedDRA and WHODrug coding with auto-coding algorithms, reconciliation workflows, dictionary version migration, and ongoing coding maintenance.
Data Entry & Cleaning
Real-time data validation at the point of entry, systematic query management, discrepancy resolution tracking, and ongoing data review cycles.
External Data Integration
Integration and reconciliation of lab data, ePRO, ECG, PK/PD, and imaging data from external vendors into a unified clinical database.
Data Transfer & Reconciliation
Standardised data transfers using CDISC formats, SAE reconciliation with safety databases, and automated central lab data imports.
Database Lock & Archival
Structured soft lock and hard lock procedures, comprehensive audit trail review, data integrity verification, and regulatory-compliant archival.
CDISC Standards Implementation
CDASH-compliant CRF standards, SDTM mapping specifications, controlled terminology alignment, and define.xml generation for submission readiness.
Flexible Engagement to Fit Your Needs
Choose the delivery model that best aligns with your organisational structure, programme complexity, and resourcing strategy.
Full-Service
End-to-end project delivery with a dedicated lead data manager overseeing every aspect of your clinical data management programme from study start-up through database lock.
- Dedicated lead data manager
- Complete lifecycle ownership
- Defined deliverables & milestones
- Turnkey project execution
FSP Model
Embedded data management teams integrated into your organisation, bringing 15–20 years of average expertise and operating as a seamless extension of your internal team.
- Embedded, dedicated resources
- 15–20 years average expertise
- Your processes, our people
- Scalable team augmentation
Hybrid
A tailored combination of project oversight and embedded resources, providing strategic CDM leadership with operational flexibility to match your programme demands.
- Project oversight & embedded staff
- Strategic CDM leadership
- Operational flexibility
- Best of both models
Deep Expertise Across Therapeutic Areas
Our data management professionals bring proven experience across a broad range of therapeutic areas, ensuring protocol-specific expertise for every study we support.
Oncology & Immuno-Oncology
Complex oncology trial data management including RECIST assessments, biomarker data, dose escalation studies, and adaptive design protocols across solid tumours and haematological malignancies.
Cardiovascular & Metabolic
Cardiovascular outcomes trials, lipid-lowering studies, diabetes programmes, and metabolic disorder investigations with specialised endpoint data management and adjudication support.
Neuroscience & CNS
CNS trial expertise covering neurodegenerative diseases, psychiatric disorders, pain studies, and neurological conditions with complex rating scale management and cognitive assessment data.
Respiratory & Infectious Disease
Respiratory efficacy trials, infectious disease studies, and antimicrobial resistance programmes with spirometry data integration, microbiology data management, and outbreak response capability.
Rare Diseases & Gene Therapy
Specialised data management for orphan drug programmes, gene therapy trials, and rare disease registries with small-population study designs, natural history data, and long-term follow-up tracking.
Vaccines & Immunology
Vaccine clinical trial data management including immunogenicity data, lot consistency studies, cold chain compliance tracking, and large-scale efficacy trial support across paediatric and adult populations.
Connected Across the eClinical Ecosystem
Our clinical data management services are deeply integrated with MTK's eClinical technology platform. Bi-directional data flows between CDM operations and our EDC, RTSM, DocuVault, and ePRO modules eliminate manual reconciliation, reduce errors, and maintain a single source of truth for your trial data.
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EDC Platform Integration
Native integration with our EDC for real-time edit check firing, automated query generation, discrepancy workflows, and seamless data flow from eCRF to the clinical database.
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RTSM Connectivity
Randomisation and treatment assignment data flows directly into the CDM database, enabling automated eligibility verification and treatment compliance tracking.
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DocuVault eTMF Integration
Data management plans, CRF completion guidelines, edit check specifications, and signed CRF pages are automatically filed to the Trial Master File for inspection readiness.
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ePRO / eCOA Integration
Patient-reported outcomes and clinician-reported assessments flow into the CDM database with automated reconciliation, compliance monitoring, and data quality checks.
Why Choose MTK for Data Management
Partnering with MTK means more than outsourcing data management. It means gaining a team that understands clinical trials, regulatory expectations, and the operational realities of delivering clean, compliant data on time.
Domain Expertise
Our data management professionals bring 15–20 years of hands-on experience across all phases and therapeutic areas, delivering protocol-specific knowledge from day one.
Integrated Platform
CDM services operate within our unified eClinical suite, connecting EDC, RTSM, ePRO, CTMS, DocuVault, and Analytics through a single, shared data layer.
Regulatory Ready
CDISC-compliant processes, 21 CFR Part 11 adherence, ICH-GCP alignment, and GDPR-ready operations with complete audit trails and inspection-ready documentation.
24/7 Support
Dedicated support team available around the clock for active studies. From query resolution to database lock support, our team is there when you need them most.
Discuss Your Data Management Needs
Connect with our clinical data management team to explore how MTK's expertise, flexible delivery models, and integrated technology platform can accelerate your clinical programme from first patient in through database lock and regulatory submission.