Sacura GmbH

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.