SERVICES

Clinical Trial Leadership & Project Management

• Global leadership of complex, multicenter trials

• End‑to‑end operational oversight and study governance

• Vendor management and cross-functional coordination

• Risk-based project steering and proactive issue management

• KPI‑driven performance monitoring and reporting

• Study rescue, turnaround strategies, and accelerated delivery models

Study Set-Up & Planning

• Operational feasibility assessments

• Protocol review and design consultation

• Country and site selection strategies

• Regulatory and ethics submission coordination

• Study plans, operational frameworks, and timeline development

• Creation of inspection‑ready documentation systems

Operational Delivery & Oversight

• Oversight of monitoring and site management

• Vendor alignment (CROs, labs, imaging, eCOA, central services)

• Audit preparation and inspection readiness

• Deviation management and CAPA leadership

• Operational risk management and adaptive planning

• Documentation integrity, quality reviews, and governance boards

Digital Trial Operations & Agile Delivery

• Integration of digital documentation and workflow solutions

• Use of AI‑assisted tools for operational insights

• Hybrid and remote monitoring models

• Digital dashboards for real-time oversight

• Agile project management structures and ceremonies

• Modernized communication pipelines

Therapeutic Expertise

Nuratis GmbH supports clinical trials across an exceptionally broad and diverse therapeutic spectrum, including but not limited to:

• Cardiovascular medicine

• Dermatology, autoimmune & inflammatory disorders

• Gastroenterology & hepatology

• Hematology & oncology

• Neurology & psychiatry

• Nutrition & metabolic disorders

• Pediatric & neonatal medicine

• Pain & anesthesiology

• Men’s & women’s health

• Rare and ultra‑rare diseases (MTM1, DNM2, LGI1, PNPO and more)

Nuratis GmbH offers comprehensive leadership and operational support for clinical trials, with experience across all phases, global regions, and therapeutic areas. Our services combine strategic oversight, hands‑on execution, and modern digital methods to enable efficient, compliant, and inspection‑ready study deliver.