Powering Clinical Trials with Data Excellence & Innovative Technology Solutions
End-to-end clinical Data Management, SAS Programming, and Biostatistics backed by a fully integrated eClinical suite — EDC, RTSM, ePRO, DocuVault, eConsent & CTMS — engineered for 21 CFR Part 11 and GDPR compliance from first patient in to regulatory submission.
Core Clinical Services
Comprehensive functional service provider solutions spanning the full clinical trial lifecycle — from protocol design through regulatory submission.
Clinical Data Management
End-to-end data management ensuring integrity and compliance across all trial phases.
- CRF Design & Database Build
- Edit Check Programming
- Medical Coding (MedDRA / WHODrug)
- Data Cleaning & Reconciliation
- Database Lock & Archival
SAS Programming
CDISC-compliant datasets, tables, listings, and figures for regulatory submissions.
- SDTM Mapping & Programming
- ADaM Dataset Creation
- TLF Generation
- Define.xml Development
- Submission-Ready Packages
Biostatistics
Rigorous statistical design and analysis for evidence-based clinical decisions.
- Study Design & Sample Size
- Statistical Analysis Plans
- Interim & Final Analyses
- Integrated Summaries (ISS / ISE)
- DSMB Support
Regulatory Affairs
Strategic regulatory guidance from pre-IND through post-market approval globally.
- Regulatory Strategy
- IND / NDA / BLA Submissions
- eCTD Publishing
- Health Authority Interactions
- Labelling & Compliance
Integrated eClinical Suite
Five purpose-built modules. One unified ecosystem. Seamless data flow from site to submission — all 21 CFR Part 11 compliant.
EDC
Intelligent electronic data capture with real-time validation and risk-based monitoring.
ExploreRTSM
Flexible randomisation with adaptive designs and real-time drug supply management.
ExploreDocuVault
Electronic Trial Master File with inspection readiness dashboards and automated filing.
ExploreeConsent
Digital informed consent with multimedia delivery, remote consent, and version control.
ExploreCTMS
End-to-end trial management with site oversight, milestones, and financial tracking.
Explore
Your Strategic Partner in Clinical Development
We combine deep domain expertise with cutting-edge technology to deliver operational excellence across every phase of your clinical programme. Our integrated approach streamlines workflows, reduces timelines, and ensures data quality from first patient in to regulatory submission.
Regulatory Expertise
Deep understanding of FDA, EMA, and MHRA requirements with a proven submission track record.
Integrated Platform
Unified tech stack eliminating data silos with real-time visibility across all operations.
Domain Specialists
Experienced biostatisticians, data managers, and SAS programmers with therapeutic expertise.
Global Reach
Supporting programmes globally with local regulatory knowledge.
One Platform. Complete Trial Oversight.
Our integrated eClinical platform connects every aspect of your clinical trial — from data capture to trial master files. Experience seamless data flow, operational transparency, and inspection readiness throughout your programme.
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Unified Data Layer
Single sign-on, shared data, and seamless integration across all modules — no data silos.
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Validated & Compliant
GAMP 5 validated, 21 CFR Part 11 compliant, GDPR-ready, and SOC 2 Type II audited.
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Cloud-Native Infrastructure
Enterprise-grade hosting with 99.9% uptime SLA, automated backups, and disaster recovery.
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Rapid Deployment
Study setup in weeks with re-usable templates, standards libraries, and automated provisioning.
Ready to Transform Your Clinical Operations?
Schedule a personalised consultation to discover how MTK Pharma Services can accelerate your clinical development programme with our integrated services and technology.
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MTK Pharma Services is a leading provider of clinical data management, SAS programming, biostatistics, and integrated clinical technology solutions for the pharmaceutical and biotechnology industry.
Heald Green, SK8 3NR, United Kingdom