Monitoring That Verifies & Controls Participants’ Rights & Safety & Data Integrity

Clinical monitoring is one of the most critical instruments for controlling the quality of clinical studies. 


 Our Clinical Research Associates (CRAs) safeguard participants 'rights, ensure adherence to study plans and protocols, and protect the integrity of trial data, while supporting site teams to operate smoothly and compliantly. 

 
Let’s discuss how our CRAs can support your next study.

Our Services

Site Monitoring & Compliance

  • Verify & control participant safety & data integrity
  • Control adherence to study protocols & GCP
  • Confirm compliance with regulatory requirements

Flexible Monitoring Models

  • Onsite monitoring across national & DACH sites 
  • Remote monitoring for efficiency & oversight 
  • Involvement of centralized monitoring activities 

 

Site Support & Communication

  • Build strong relationships with site teams
  • Support the proactive identification of issues
  • Foster open communication between sponsor, CRO, & investigators

Site Monitoring & Compliance

  • Verify & control participant safety & data integrity
  • Control adherence to study protocols & GCP
  • Confirm compliance with regulatory requirements

Flexible Monitoring Models

  • Onsite monitoring across national & DACH sites 
  • Remote monitoring for efficiency & oversight 
  • Involvement of centralized monitoring activities 

Site Support & Communication

  • Build strong relationships with site teams
  • Support the proactive identification of issues
  • Foster open communication between sponsor, CRO, & investigators

How We Work

  • 01Prepare

    Define monitoring plan based on risk management.

  • 02Monitor

    Onsite and/or remote visits for compliance & oversight.

  • 03Report

    Provide clear, actionable updates on findings & risks to sponsor & investigator.

  • 04Adapt

    Learn based on observations & discuss adaptation of site-specific monitoring.

Why Sponsors Choose Us

Experienced CRAs

A strong network across DACH with therapeutic expertise.

Human-Centered

Technical rigor with excellent communication skills. 

Flexible Models

Remote & onsite solutions designed for efficiency. 

Compliance & Training

ICH E6(R3) & ISO 14155 compliance
BVMA member being regularly audited
Internal & External trainings

Monitoring That Prevents Findings

Real oversight, not checkbox compliance

    • Early issue detection through pattern recognition
    • Site performance support, not just documentation
    • Risk-based SDV aligned to study needs
    • Inspection-ready monitoring documentation
    • Flexible support: full-service or supplemental coverage

Ready to Strengthen Your Clinical Monitoring?

Call Kirstin Steffen directly on +49 (0) 1520 921 96 38 or write us an email.

Schedule a Consultation

Ready to Strengthen Your Clinical Monitoring?

Call Kirstin Steffen directly or write us an email.

Kirstin Steffen

+49 1520 921 96 38
info@forschungsdock.de

Schedule a Consultation