info@mtkpconsulting.com 21 CFR Part 11 Compliant GDPR · GxP · HIPAA
Trusted by Sponsors, CROs & Clinical Sites Worldwide

Accelerate Clinical Trials with Our Unified eClinical Platform

Nine purpose-built modules — from EDC and RTSM to eConsent and real-time analytics — designed for regulatory compliance, operational efficiency, and faster time to database lock.

21 CFR Part 11 GDPR ICH-GCP HIPAA GAMP 5
mtkpconsulting.com/platform
2,847
Subjects Enrolled
142
Active Sites
99.2%
Data Quality
Enrolment Progress
Audit Trail Active
FDA Validated
Ensuring Global Compliance With
21 CFR Part 11 GDPR GxP HIPAA ICH-GCP E6(R3) CDISC GAMP 5 SOC 2 Type II
0+
Clinical Trials Supported
0
Integrated eClinical Modules
0+
Countries Covered
0.8%
Platform Uptime

Nine Modules. One Unified Ecosystem.

Every module is purpose-built for clinical research, fully validated, and designed to work together or independently within your existing technology stack.

EDC

Electronic Data Capture

Streamline study builds with CDISC-aligned CRF design, intelligent edit checks, and automated query management for faster database lock.

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RTSM / IRT

Randomisation & Trial Supply

Configurable randomisation algorithms, real-time drug supply forecasting, and blinding management with complete audit trails.

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CTMS

Clinical Trial Management

Centralised site management, milestone tracking, financial oversight, and operational dashboards for end-to-end study execution.

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ePRO / eCOA

Patient Reported Outcomes

Validated instruments across mobile, tablet, and web with smart reminders, offline capability, and multi-language support.

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eConsent

Digital Informed Consent

Multimedia-rich consent flows with comprehension checks, remote e-signatures, version control, and IRB/EC integration.

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DocuVault eTMF

Electronic Trial Master File

DIA reference model structure, automated filing, quality review workflows, completeness dashboards, and inspection-ready exports.

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rSDV

Remote Source Verification

Secure remote access to source documents, structured verification workflows, and seamless EDC integration for decentralised monitoring.

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eClinical Analytics

Intelligence & Reporting

Cross-module dashboards with configurable KRIs, predictive modelling, risk signal detection, and automated regulatory reporting.

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Adjudication

Endpoint Adjudication

Committee management, blinded case dossier assembly, consensus voting workflows, and comprehensive adjudication analytics.

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Strategic Expertise Across the Clinical Lifecycle

Beyond technology, our domain experts bring decades of hands-on experience in pharmaceutical consulting, regulatory strategy, and clinical operations.

  • Regulatory strategy and global submission planning
  • Clinical data management and CDISC standards
  • Biostatistics and statistical analysis plans
  • SAS programming for TLFs and SDTM/ADaM
  • Quality assurance and GxP compliance audits
  • Pharmacovigilance and safety reporting
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Partnering Across the Life Sciences Ecosystem

Pharma & Biotech

Supporting sponsors from early phase through post-marketing with end-to-end clinical technology and consulting services.

Contract Research Organisations

Scalable, multi-sponsor platform infrastructure with rapid study configuration and enterprise-grade SLA support.

Clinical Sites & Hospitals

Intuitive tools that simplify site workflows, reduce administrative burden, and accelerate patient enrolment timelines.

Built for the Demands of Modern Clinical Research

Unified Platform

All nine modules share a common data layer, eliminating silos and enabling cross-functional visibility.

Validated & Compliant

Full IQ/OQ/PQ validation documentation with electronic signatures and comprehensive audit trails.

Cloud-Native Architecture

Secure, scalable multi-tenant infrastructure with 99.8% uptime and SOC 2 Type II certification.

Rapid Deployment

Go live within weeks, not months. Pre-configured templates and guided setup reduce time to first patient.

Ready to Transform Your Clinical Trials?

Discover how our integrated platform and consulting expertise can streamline your operations and accelerate your path to regulatory approval.

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