The vital roles of the Clinical Operations team ensure timely and efficient planning, execution and conclusion of each clinical trial.
By combining science and state-of-the-art technologies, Europital optimizes each step in the clinical trial process whilst maintaining the highest regulatory standards, the safety of the patients and scientific integrity of the data collected.
Our seasoned project managers utilize their technology management capabilities to integrate the most advanced clinical research technologies in the daily clinical trial operations to ensure quality and efficiency.
With its broad experience in drug development and clinical research in various therapeutic areas and disease indications, Europital project management team ensures appropriate planning, efficient execution, and timely conclusion of your clinical project.
We adopt an agile management approach with the expert Core Team assigned to each project, assuming full responsibility of organization and execution of the project together with guidance, coordination and supervision of regional and local operation teams.
Europital Project Managers are the driving force for all cross-functional activities in our projects:
- Primary point of contact to sponsor
- Project planning and implementation with full oversight and coordination of various activities
- Ensuring compliance with ICH-GCP, applicable regulations and SOPs, and the study protocol
- Recruitment and retention strategies
- Grant and Vendor Management
- Technology Management, such as CTMS, EDC, IWRS, CTSU, IGMS
- Management of Trial Master File
- Management of Budget and Payments
- Risk assessment and CAPA
Clinical monitoring is an inevitable quality control process that happens before, during and after a trial is conducted. Essentially, clinical monitors have the responsibility of checking that the protocol is being followed by investigational sites and thereby ensure the integrity of the trial data being recorded and the protection of the study participant’s wellbeing. The monitor performs a range of activities to verify that the study is being performed well and to report this information to Project Management, with suggestions for CAPA.
Beside their monitoring experience in various therapeutic areas and disease indications, and the continuous support by the Europital study management team, all monitors at Europital have the scientific background and clinical training that enables them to manage the particular requirements of each study.
- Feasibility and Site Identification
- Site Initiation and Management
- Study Monitoring: onsite visits, virtual, remote and wearables
- Site communication and project-specific training
- Accountability for sites’ study documents and materials