Expert Guidance and Support When You Need It

You don't always need full-service delivery. Sometimes you need strategic advice on service provider selection, a second opinion on your risk management plan, or help building a Quality Management System from scratch. We provide on-demand consulting to fill specific gaps—bringing 180+ years of combined expertise in clinical operations, medical writing and quality management to your toughest decisions. 

 
Discuss Your Challenge

Four Core Consulting Areas

strategic-clinical-trial-setup-planning-services

Study Set-up, Risk Management & Operational Planning

Risk-based Quality Management (RbQM) frameworks, contingency planning, and study feasibility reviews. We identify operational risks early and build mitigation strategies that prevent delays and findings.

Service Provider Selection & Management Strategy

Whether it is an independent assessment of CRO proposals, the assessment of your vendor qualification outcomes or support in contract negotiations - we deliver assessments that help you make the right decisions and choose the right partner for you. 

Forschungsdock_CRO_Team

Quality Management System (QMS) Design

Gap analysis of existing systems, SOP development roadmaps, quality oversight frameworks, audit preparation, and inspection readiness reviews. We design quality systems that work in practice—not just on paper.

GCP Best Practice Training & Team Development

Role-specific GCP and best practice training for sponsors, sites, and monitors. Practical, scenario-based sessions led by experienced auditors who know what inspectors actually look for during regulatory visits. 

strategic-clinical-trial-setup-planning-services

Study Set-up, Risk Management & Operational Planning

Risk-based Quality Management (RbQM) frameworks, contingency planning, and study feasibility reviews. We identify operational risks early and build mitigation strategies that prevent delays and findings.  

Forschungsdock_CRO_Team

Service Provider Selection & Management Strategy

Whether it is an independent assessment of CRO proposals, the assessment of your vendor qualification outcomes or support in contract negotiations - we deliver assessments that help you make the right decisions and choose the right partner for you. 

Quality Management System (QMS) Design

Gap analysis of existing systems, SOP development roadmaps, quality oversight frameworks, audit preparation, and inspection readiness reviews. We design quality systems that work in practice—not just on paper. 

GCP Best Practice Training & Team Development

Role-specific GCP and best practice training for sponsors, sites, and monitors. Practical, scenario-based sessions led by experienced auditors who know what inspectors actually look for during regulatory visits. 

How We Work

  • 01Identify

    Understand your specific challenges, gaps, or decision points

  • 02Assess

    Review your situation, identify gaps, and evaluate solution options that fit your operational context

  • 03Advise

    Provide strategic recommendations based on your individual situation, taking regulatory requirements and operational reality into account.

  • 04Support

    Available during execution, implementation and for follow-up questions, reviews, or ongoing advisory needs

Why Sponsors Choose Us

Senior Expertise

Team with 180+ years combined experience in clinical operations, medical writing and quality management (20-40+ years individual expertise among senior consultants) 

Flexible Engagement

On-demand support without long-term contracts or full-service commitments 

Practical Solutions

Advice grounded in operational reality, not theoretical compliance 

Independent Perspective

Objective guidance without vendor conflicts of interest

Compliance & Training

Deep GCP Expertise

180+ years combined team experience in operations and consulting

Regulatory Knowledge

ICH E6(R3), Reg (EU) No. 536/2014, ISO 14155, Reg. (EU) 2017/745, ISO 13485

Sponsor & CRO Experience

Our Team has worked sponsor-side and CRO-side—understanding both client needs and operational delivery

When to engage consulting vs. Oversight support vs. Full-service delivery

Consulting

  • You need expert input on specific decisions
  • You have internal capabilities and want second opinion 
  • You intend to build competencies through training
  • You seek flexible, on-demand advisory

Sponsor Oversight

  • You outsourced to CRO but need support in vendor management and oversight 
  • Your small internal team can't monitor CRO daily
  • You seek strategic oversight without full headcount
  • You expect regulatory-compliant oversight documentation 

Full Study Management

  • You need end-to-end trial execution with a single accountability 
  • You want integrated PM, medical writing, operations, and DM/Stats 
  • You have preference for one team vs. multiple vendor coordination 
  • You await  delivery without internal Clinical Ops 

What clinical operations challenge can we help you solve?

Whether you need strategic vendor advice, quality system design, or GCP training—let's discuss how focused consulting support can address your specific needs. 

Call Dr. Doris Greiling on +49 (0) 1520 921 96 49 or Dr. Christoph Ortland on +49 (0) 1520 921 89 32, or write us an email.

Christoph Ortland
+49 (0) 1520 921 89 32

Doris Greiling
+49 (0) 1520 921 96 49
info@forschungsdock.de

Schedule a Consultation

What clinical operations challenge can we help you solve?

Whether you need strategic vendor advice, quality system design, or GCP training—let's discuss how focused consulting support can address your specific needs. 

Call Dr. Doris Greiling on +49 (0) 1520 921 96 49 or Dr. Christoph Ortland on +49 (0) 1520 921 89 32, or write us an email.

Schedule a Consultation