Project Management
End-to-end management ensuring quality, compliance, and on-time delivery.
Our Project Management services provide full oversight of the clinical trial lifecycle—from planning and start-up, through execution, to final study close-out. We ensure efficient coordination, timeline adherence, regulatory compliance, and transparent communication with the Sponsor.
Scope of Project Management Services
1. Study Start-Up
• Development of Study Plans and project timelines
• Coordination of kick-off meetings
• Establishment of communication pathways and escalation procedures
• Risk identification and preparation of the Risk Management Plan
• Selection and qualification of local partners and vendors
2. Execution & Oversight
• Daily coordination of clinical trial operational activities
• Monitoring of recruitment, timelines, and key milestones
• Oversight of compliance with GCP, protocol, and regulatory requirements
• Ensuring audit and inspection readiness
• Verification of visit reports (SEV, SIV, COV, MV)
3. Team Leadership
• Assignment and supervision of the project team (CRA, Data Management, Safety)
• Ensuring appropriate training and alignment across the study team
• Regular operational meetings and timeline reviews
4. Communication & Reporting
• Monthly status reports and KPI updates
• Organization of project review meetings and Data Review Meetings
• Monthly Sponsor Report
• BDRM Preparation
• Investigator Meeting – preparation and attendance coordination
5. Vendor & Site Management
• Selection, negotiation, and oversight of subcontractors and vendors
• Monitoring service quality and regulatory compliance
• Site Budget Management
6. Risk & Issue Management
• Continuous evaluation of study risks and deviations
• Implementation of CAPA and preventive actions
• Early identification of delays or quality concerns
7. Study Close-Out
• Coordination of close-out visits and document archiving
• Final data review and resolution of outstanding queries
• Preparation of the final project report and “lessons learned” summary
Our Approach
Our project managers combine strategic oversight with operational detail orientation, ensuring that every project phase runs seamlessly. Their in-depth therapeutic knowledge, proactive risk assessment, and commitment to collaboration make them key drivers of study success -locally and globally.
Dossier Preparation & Product Registration
Our Regulatory Affairs specialists assist in preparing and submitting:
- CTD/eCTD dossiers for human and veterinary medicines
- Technical Documentation (TD) for medical devices
- Product Information Files (PIF) for cosmetics
- Food Supplement Documentation
We guide clients through EU marketing authorization procedures, from dossier assessment to product registration - ensuring full compliance and efficiency at every step.
