Clinical Trial Services

Comprehensive clinical research organization services from protocol development to regulatory submission across Europe

Our Clinical Trial Services

Protocol Design & Development

Expert protocol development ensuring scientific rigor and regulatory compliance

  • Protocol design and optimization
  • Statistical planning and sample size calculation
  • Endpoint selection and validation
  • Regulatory strategy alignment

Regulatory Affairs & Submissions

Complete regulatory support including CTIS submissions and authority interactions

  • Clinical Trial Authorization (CTA) applications
  • CTIS submissions and management
  • Ethics committee applications
  • Regulatory correspondence and queries

Site Identification & Management

Strategic site selection and comprehensive site management services

  • Site feasibility and selection
  • Site qualification and contracting
  • Site initiation and training
  • Ongoing site support and communication

Patient Recruitment & Retention

Innovative strategies to optimize patient enrollment and trial completion

  • Recruitment strategy development
  • Digital recruitment campaigns
  • Patient screening and enrollment
  • Retention program implementation

Clinical Data Management

Comprehensive data management ensuring quality, integrity, and regulatory compliance

  • Electronic Data Capture (EDC) setup
  • Data entry and query management
  • Data validation and cleaning
  • Database lock and transfer

Clinical Monitoring & Quality

Risk-based monitoring ensuring data quality and protocol compliance

  • Risk assessment and monitoring plan
  • On-site and remote monitoring
  • Source data verification
  • Quality control and audits

Biostatistics & Data Analysis

Expert statistical analysis and reporting for regulatory submissions

  • Statistical analysis plan (SAP) development
  • Interim and final statistical analysis
  • Safety and efficacy reporting
  • Regulatory submission support

Medical Writing & Reporting

Professional medical writing for clinical study reports and regulatory documents

  • Clinical study reports (CSR)
  • Investigator brochures
  • Regulatory submission documents
  • Scientific publications

Clinical Trial Phases

I

Phase I

Focus: Safety & Dosing

Participants: 20-100 healthy volunteers or patients

Duration: Several months

  • Determine maximum tolerated dose (MTD)
  • Evaluate safety and side effects
  • Assess pharmacokinetics and pharmacodynamics
  • Establish recommended Phase II dose
II

Phase II

Focus: Efficacy & Safety

Participants: 100-300 patients

Duration: Several months to 2 years

  • Evaluate preliminary efficacy
  • Further assess safety profile
  • Determine optimal dose and schedule
  • Identify target patient population
III

Phase III

Focus: Comparative Effectiveness

Participants: 300-3,000 patients

Duration: 1-5 years

  • Compare to standard of care
  • Confirm efficacy in larger population
  • Monitor adverse reactions
  • Support regulatory submission
IV

Phase IV

Focus: Post-Marketing Surveillance

Participants: Thousands of patients

Duration: Ongoing

  • Long-term safety monitoring
  • Rare adverse event detection
  • Real-world effectiveness
  • Quality of life assessments

EU Clinical Trials Regulation (CTR)

Our clinical trial services are fully aligned with the EU Clinical Trials Regulation (EU) 536/2014 and the Clinical Trials Information System (CTIS), ensuring streamlined regulatory compliance across all EU Member States.

CTR Key Benefits

🌍

Single EU Submission

One application for multiple EU countries through CTIS

⚡

Streamlined Process

Faster approval timelines and simplified procedures

📊

Transparency

Enhanced public access to clinical trial information

🔒

Data Protection

Robust data protection aligned with GDPR

CTIS
DE
FR
IT
ES
NL
BE
AT
+20

Technology & Innovation

Clinical Data Management

Electronic Data Capture (EDC)

  • Medidata Rave
  • Oracle Clinical
  • REDCap
  • Veeva Vault CDMS

Clinical Trial Management Systems

  • Veeva Vault CTMS
  • Oracle Siebel CTMS
  • Medidata Clinical Cloud
  • Custom CTMS solutions

Patient Engagement

ePRO & Digital Health

  • Electronic patient-reported outcomes
  • Mobile health applications
  • Wearable device integration
  • Telemedicine platforms

Patient Recruitment

  • Digital recruitment platforms
  • Social media campaigns
  • Patient registries
  • AI-powered matching

Data Analytics

Statistical Software

  • SAS Clinical
  • R Statistical Computing
  • SPSS Advanced
  • Stata Medical

Risk-Based Monitoring

  • CluePoints
  • Medidata Acorn AI
  • Oracle RBM
  • Custom analytics dashboards

Quality Standards & Compliance

ICH GCP

International Conference on Harmonisation Good Clinical Practice guidelines compliance

  • ICH E6(R2) implementation
  • Quality by Design approach
  • Risk-based monitoring
  • Data integrity (ALCOA+)

EU CTR

European Union Clinical Trials Regulation and CTIS compliance

  • EU CTR 536/2014 compliance
  • CTIS submission expertise
  • Risk categorization
  • Transparency requirements

ISO Standards

International quality standards for clinical research organizations

  • ISO 14155 (Clinical Investigation)
  • ISO 27001 (Information Security)
  • ISO 9001 (Quality Management)
  • ISO 13485 (Medical Devices)

Our Clinical Trial Process

1

Study Design & Planning

Protocol development, regulatory strategy, and feasibility assessment

2-6 months
2

Regulatory Approval

CTIS submission, ethics committee approval, and site authorization

2-4 months
3

Site Initiation & Recruitment

Site setup, staff training, and patient enrollment

3-12 months
4

Study Conduct & Monitoring

Patient visits, data collection, and quality monitoring

6-36 months
5

Data Analysis & Reporting

Statistical analysis, clinical study report, and regulatory submission

3-6 months

Accelerate Your Clinical Development

Partner with our clinical trial experts for comprehensive support from protocol to approval

Request Clinical Consultation Download Clinical Guidelines