Clinical Operations followed by high quality support
The department "Clinical Operations" ensures monitoring of projects in strict compliance with "Good Clinical Practice".
The Monitoring team is dedicated to setting up and monitoring Phase I to IV trials as well as observational studies.
ATLANSTAT puts all the experience, expertise and capabilities of a successful team to:
- Selecting study centers / experts at National or International level
- Implementing feasibility studies
- Assessing costs and time
- Preparing study documents:
- Protocol designing and writing (including informed consent)
- Case Report Form designing
- Preparing and submitting regulatory documents to the competent authorities (ANSM, CPP, CNIL, CNOM) as well as Medical devices specificities (incl. Notified bodies links for Medtech)
- Managing experimental products (import, supply, ...)
- Preparing and participating in investigator meetings
- Organizing clinical site visits and individualized training for study staff
- Managing clinical study monitoring
- Closing study centres
- Managing other stakeholders or partners
Our medical writers have expertise in different therapeutical areas. They can write various clinical study reports in ICH format.
They can also write Clinical Evaluation Report (CER), Post-market Clinical follow-up (PMCF) Plan and report for Medtech
Our consultants may also assist you in writing specific documentation needed for submissions to regulatory authorities, in particular safety narratives.