Complete Study Management—From Design to Submission

End-to-end trial execution with integrated project management, medical writing, clinical monitoring, data management, and regulatory support. One accountable team managing all operational aspects—so you focus on strategy while we handle delivery.

 
Lets plan your next study together.

Four Core Pillars of Full-Service Trial Management

strategic-clinical-trial-setup-planning-services

Strategic Study Setup & Planning

Protocol development support, statistical design consultation, regulatory strategy, risk assessment, and realistic timeline planning. Every study begins with sound design and operational alignment.

Integrated Project Management

Your operational hub coordinating sites and service providers. From first submission over thorough clinical monitoring to final report, we manage timelines, documentation via eTMF, budgets, and performance—keeping every moving part aligned and on track. 

integrated-clinical-trial-project-management-monitoring
medical-writing-clinical-trial-documentation-services

Medical Writing & Documentation

Protocols, investigator brochures, informed consent forms, clinical study reports, regulatory submissions, and all study documentation. Written by experienced medical writers who understand both science and regulatory requirements.

Biostatistics & Data Management

Statistical Analysis and Data Management plans, database design and validation, data cleaning and quality checks, interim and final analyses, and submission-ready datasets. Under the lead of our Project Management, our preferred business partner produces clean data, robust statistics, and inspection-ready deliverables. 

biostatistics-clinical-data-management-trials
strategic-clinical-trial-setup-planning-services

Strategic Study Setup & Planning

Protocol development support, statistical design consultation, regulatory strategy, risk assessment, and realistic timeline planning. Every study begins with sound design and operational alignment.

integrated-clinical-trial-project-management-monitoring

Integrated Project Management

Your operational hub coordinating sites and service providers. From first submission over thorough clinical monitoring to final report, we manage timelines, documentation via eTMF, budgets, and performance—keeping every moving part aligned and on track.

medical-writing-clinical-trial-documentation-services

Medical Writing & Documentation

Protocols, investigator brochures, informed consent forms, clinical study reports, regulatory submissions, and all study documentation. Written by experienced medical writers who understand both science and regulatory requirements.

biostatistics-clinical-data-management-trials

Biostatistics & Data Management

Statistical Analysis and Data Management plans, database design and validation, data cleaning and quality checks, interim and final analyses, and submission-ready datasets. Under the lead of our Project Management, our preferred business partner produces clean data, robust statistics, and inspection-ready deliverables.

How We Work

  • 01Plan

    Design and protocol development, regulatory strategy, risk framework

  • 02Execute

    Study setup, submissions, site coordination, monitoring, and operational oversight

  • 03Analyze

    Data management, statistical analyses, quality reviews

  • 04Deliver

    Clinical study reports, essential documentation, compliant closeout

Why Sponsors Choose Us

Single Point of Accountability

One experienced Project Manager managing the study  from start to finish

Integrated Expertise

A seasoned, focused team working in close alignment

Prevention-First Quality

Quality-driven set-up, lean and pragmatic approach

Compliance & Training

GCP is in our blood

ICH-GCP E6(R2/R3), Reg (EU) 536/2014 (CTR), ISO 14155

Proven track record

Phase I-IV studies and pre-CE/PMCF studies across therapeutic areas

Inspection-Ready from Day 1

eTMF, datasets, and documentation built for regulatory scrutiny

Experienced Team

Seasoned experts with experience in CRO and sponsor processes

Your Operational Backbone—Start to Finish

End-to-end execution with single-point accountability

  • Dedicated study team from protocol development to final report 
  • No vendor compliance gaps due to validated service provider software 
  • One point of contact for all operational decisions and deliverables 
  • Proactive risk management and early issue escalation 
  • Transparent reporting with realistic timeline assessments 
  • Digitalized processes from risk management to trial master filing 

What this means: Risk-based and goal-focused study startup, smooth execution, compliant documentation, and on-time delivery to regulatory milestones.

 

Ready for integrated study management?

Let's discuss your study requirements and show you how we eliminate coordination gaps while maintaining the highest quality standards. 

Call Dr. Doris Greiling directly on +49 (0) 1520 921 96 49 or write us an email.

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

Schedule a Consultation

Let’s plan your next study together.

Call Dr. Doris Greiling directly on +49 (0) 1520 921 96 49 or write us an email.

Schedule a Consultation