Each research project is unique and requires special attention. It is therefore important to consider carefully our clients’ needs in order to make our resources as flexible as possible and achieve greater efficiency.
HealthCo Trials has the necessary experience to carry out any of the processes involved in the implementation, development and closure of your research project, including the following activities:
- Preparation of project-specific documentation (Protocol, IMPD, Patient Information Sheet, Case Report Forms…).
- Selection of study sites and pre-study visits.
- Preparation of documentation and submission of the project to the competent authorities.
- EudraCT application and addition of the project into applicable databases.
- Negotiation and sign-off of financial agreements.
- Organization of investigators’ meetings.
- Start-up visits and on-site team training.
- Development of Project Plans, including Data Management, Medical, Recruitment, Risk Management Plan etc.).
- Comprehensive project management (Project Management).
- Creation and maintenance of the Trial Master File (TMF).
- Remote and face-to-face monitoring of the study.
- Ongoing reporting on the progress of the study to the client.
- Database collection, cleaning and closure.
- Close-Out visits.
- Identification and coordination of third party vendors.
- Management and final reconciliation of the product under research.
- Monitoring and communication of adverse events.
- Audits and quality controls, both internal and external.