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

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

  • Study design input & operational study setup 
  • Support in all stages of risk management 
  • Submission to ethics committees & regulatory authorities 
  • Continuous coordination with sites, service providers, & internal teams 
  • Sponsor consulting, communication & information 

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

We Assure

  • Consistent quality control at all study sites 
  • Flexible national & DACH monitoring coverage 
  • High confidence in compliance & data integrity 
  • Strong network of CRAs with both technical & communication skills 

 

Ready to Strengthen Your Clinical Monitoring?

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

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