Clinical research is an essential step to verify the safety and efficacy of newly discovered drugs/medical devices.
Clinical research is conducted in an international setting and is subject to ethical principles and international and local rules and regulations.
EVA Clinical Research provides consultancy in different aspects of clinical research in Europe. The core activities cover BeNeLux and France.
Functional Areas:
Project Management: The project manager is responsible for the coordination and oversight of each operational component of a project such as:
- Ensure each team member is adequately trained
- Serve as a link between sponsor and project stakeholders
- Coordinate third-parties and vendors
- Supervise the project team
- Coordinate and track all project related activities in a Project Management System
- Ensure compliance with project timelines and budget
- Communicate trial progress and milestones to key stakeholders
Study Start-up: Covers all types of activities to enable the start of a study including:
- Feasibility studies and site selection
- Development, customization and translation/validation of study documents (e.g. Informed Consent Form, Patient Diaries, Emergency Card, IMP label)
- Ethics and Competent Authorities submissions
- Privacy Committee submissions (if applicable)
- Site contract and budget negotiations
- Preparation of Investigator Site Files and Trial Master File
Regulatory (Ethics and Competent Authority submissions): Government regulation is a very important component in the conduct of a clinical trial. EVA Clinical Research offers a broad range of services to assist with regulatory requirement:
- Clinical Trial Application
- Clinical Trial Amendments
- Submission of annual Safety Update Reports (DSUR)
- Notification of End of Study
- Other study-specific notifications as required
Monitoring: The monitor should ensure that the trial is conducted and documented properly. The following activities are carried out:
- Site Qualification Visits
- Site Initiation Visits
- On-site and/or Remote monitoring visits
- Unblinded Pharmacy monitoirng visits (if required)
- Ongoing site management
- Site Close-out Visits