Solutions for Pharmaceutical Sponsors
Accelerate your clinical development programme with MTK Pharma's enterprise-grade eClinical platform and end-to-end consulting services. From protocol design through regulatory submission, we deliver integrated technology and deep domain expertise tailored for pharmaceutical and biotech sponsors running complex, multi-regional trials.
A Strategic Partner for Your Clinical Programme
MTK Pharma serves as a single strategic partner for pharmaceutical and biotech sponsors seeking to modernise their clinical operations. Our integrated eClinical platform eliminates the fragmentation that comes from stitching together point solutions from multiple vendors, giving your team a unified data environment from first patient enrolled through database lock.
Beyond technology, our team of clinical data managers, biostatisticians, regulatory specialists, and SAS programmers works alongside your organisation to deliver operational excellence at every stage of the trial lifecycle. Whether you need a fully outsourced model or targeted functional support, we adapt to your operating structure and therapeutic requirements.
Comprehensive Services for Every Need
From full-service outsourcing to targeted functional support, MTK Pharma provides flexible engagement models backed by validated technology and experienced clinical operations professionals.
End-to-End Platform
Access our complete integrated eClinical suite covering the full trial lifecycle, from study build and data capture through analysis, reporting, and submission.
- Unified data environment across all modules
- Single vendor accountability
- Streamlined system validation
- Reduced integration complexity
Full-Service Outsourcing
Delegate your entire clinical data operations to MTK Pharma. Our experienced teams manage every aspect from database design through clean file delivery.
- Dedicated project management
- Complete data management services
- Biostatistics and SAS programming
- Regulatory submission support
Functional Service Provider (FSP)
Augment your internal capabilities with dedicated MTK professionals who integrate seamlessly into your existing workflows and governance structures.
- Embedded team members at your organisation
- Flexible resource scaling
- Your SOPs and processes followed
- Consistent quality across studies
Strategic Partnerships
Build a long-term relationship with MTK Pharma as your preferred eClinical partner, benefiting from volume-based pricing and dedicated account governance.
- Preferred partnership agreements
- Volume-based commercial terms
- Joint innovation roadmap
- Executive-level governance
Regulatory Strategy
Navigate the evolving regulatory landscape with confidence. Our regulatory affairs specialists guide your submissions across FDA, EMA, PMDA, and other global authorities.
- Submission-ready deliverables
- Multi-authority filing expertise
- CDISC standards implementation
- Inspection readiness preparation
Data Analytics & Insights
Transform your clinical data into actionable intelligence with advanced analytics, risk-based quality management, and real-time operational dashboards.
- Real-time study performance metrics
- Risk-based quality management
- Predictive enrolment modelling
- Cross-study trend analysis
Choose the Model That Fits Your Organisation
Every sponsor operates differently. MTK Pharma offers four distinct engagement models so you can select the level of support that aligns with your internal capacity, therapeutic complexity, and strategic priorities.
Full Outsourcing
Hand over your complete clinical data operations to MTK Pharma. We manage technology, processes, and personnel from study start-up through final deliverables, acting as an extension of your organisation.
FSP Model
Embed dedicated MTK professionals within your team to fill specific functional gaps. Our staff work under your governance, follow your SOPs, and scale up or down as your pipeline demands.
Hybrid Model
Combine the strengths of outsourcing and FSP. Retain control over core strategic functions while MTK Pharma delivers specialised services such as database builds, statistical programming, or regulatory submissions.
Technology-Only
License MTK Pharma's validated eClinical platform for your internal teams to operate independently. We provide the technology, training, and technical support while your staff manage the studies.
Ten Modules. One Unified Platform.
Every module in the MTK eClinical suite shares a common data layer, single sign-on, and unified audit trail. Sponsors benefit from reduced integration risk, faster study start-up, and a single source of truth across the entire trial lifecycle.
EDC
Electronic Data Capture
RTSM
Randomisation & Trial Supply
CTMS
Clinical Trial Management
ePRO
Electronic Patient Outcomes
eConsent
Electronic Consent
DocuVault
Electronic Trial Master File
rSDV
Remote Source Verification
Analytics
Operational Intelligence
Adjudication
Clinical Event Adjudication
RBQM
Risk-Based Quality Management
Partner With Us
Discover how MTK Pharma's integrated platform and experienced clinical teams can streamline your trial operations, reduce timelines, and deliver submission-ready data with confidence. Schedule a consultation to explore the right engagement model for your organisation.