CLINICAL SERVICES

Project

Management

Based in the European Union, fully GCP compliant, with a dedicated Phase I unit of up to 72+ participants.

Effective project management is central to the successful execution of clinical trials. CRS provides dedicated Project Management services to ensure that studies are delivered on time, within budget, and in full compliance with protocol and regulatory requirements.

Our project managers oversee the study from initiation through close-out, serving as the primary point of contact for sponsors and coordinating all operational activities. We develop and maintain detailed project plans, timelines, and communication frameworks that align study objectives with operational execution. Clear governance structures and defined responsibilities support efficient decision-making throughout the study lifecycle.

CRS ensures cross-functional coordination between clinical operations, regulatory affairs, pharmacovigilance, data management, and third-party vendors. We proactively identify risks, track key milestones, and implement mitigation strategies to address potential issues before they impact study timelines or data quality. Regular status reporting provides sponsors with transparent oversight of study progress and resource utilization.

During study conduct, our project managers support protocol compliance, change management, and issue resolution. We coordinate amendments, oversee site and vendor performance, and ensure that study documentation and deliverables are managed in accordance with applicable standards and internal procedures.

By applying a structured, pragmatic, and experience-based approach, CRS project management supports predictable study execution, effective stakeholder alignment, and the successful delivery of high-quality clinical trial outcomes.
Request For Proposal
  • Ethics Committee approval for all studies
  • Regulatory strategy and regulatory submissions
  • Study start-up and site activation
  • Clinical trial planning and study design
  • Clear participant information and informed consent
  • Conducted in compliance with ICH-GCP and EU regulations
  • 24/7 safety monitoring and emergency readiness
  • Qualified investigators and trained study teams
  • Confidential handling of participant data

20+ Years

Of Experience in Early-Phase Clinical Research

Phase I Unit

Infrastructure organized across two dedicated units for controlled inpatient studies

EU Certified CRO

Slovenia, European Union regulatory environment

GCP Compliant

Conduct under international quality standards