---
name: Sacura GmbH
slug: sacura-cro
site: cro
website_domain: sacura-cro.com
summary: Sacura specializes in clinical trial management and regulatory support for biotech and pharma companies, with expertise in complex international studies and late-stage preclinical-to-market development planning.
tagline: Clinical trial management and regulatory support for complex international studies.
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tier2_domain_verified: false
updated_at: 2026-10-04T07:01:01.473Z
services_count: 8
modalities_count: 0
indications_count: 0
locations_count: 0
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Sacura GmbH

Clinical trial management and regulatory support for complex international studies.

Listed on cro.directory.

## Summary

Sacura specializes in clinical trial management and regulatory support for biotech and pharma companies, with expertise in complex international studies and late-stage preclinical-to-market development planning.

## Services

- Phase II Clinical Trials
- Clinical Trial Services
- EU EMA Regulatory Strategy
- Clinical Operations
- Phase I Clinical Trials
- Phase III Clinical Trials
- Regulatory Affairs
- US FDA Regulatory Strategy

## Long description

Sacura GmbH is a clinical research organization focused on the preparation, setup, management, and execution of international clinical trials. The company serves biotechs, academic institutions, and medical device companies, with particular expertise in complex and challenging trial designs.

**Core Capabilities:**
- Complete clinical trial lifecycle management from Target Product Profile (TPP) to market access
- Project planning, budgeting, cost management, and resource coordination
- Quality assurance and systematic risk management
- On-site monitoring, clinical monitoring, centralized monitoring, and data monitoring
- Regulatory submission and reporting to competent authorities, ethics committees, and institutional review boards
- Site selection, investigator coordination, and pre-study site assessment
- Document management via proprietary web-based eTMF system (e.tract)
- GCP training and audit preparation support

**Specialization:**
Sacura emphasizes support for biotechs in late-stage preclinical development planning their first clinical study, offering management consultancy, crisis management, and rescue study experience. The organization leverages a network of veterans from leading pharmaceutical companies and has managed over 130 clinical trials.

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_Profile last updated: 2026-10-04T07:01:01.473Z. Profile facts may include AI-assisted enrichment._

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