Iris Pharma's project leaders are the study managers and also the sponsor's principal contact person. They remain responsible throughout the evaluation phase and supervise the study schedule up to the production of the final report. Our project leaders are experienced staff who are regularly trained in Good Clinical Practice (GCP), study monitoring guidelines, local legislations and ophthalmologic pathologies.
The project leaders manage Phase I to phase IV clinical research studies with the highest level of diligence in setting up, monitoring and concluding each study to achieve excellent clinical results.
Main responsibilities of project leaders:
- National submissions in all European Countries.
- Scientific writing (protocol summaries, case report forms, informed consent, patient information sheets, patient diaries and amendments).
- Investigator selection.
- Distribution of files to investigators, hospital director, hospital pharmacy and trial master file.
- Investigators and hospital contract.
- Investigators' meetings.
- Monitoring guideline: edited before study start to harmonize the monitoring.
- Study specific training of our Clinical Research Associates (CRAs).
- Continuous updates of patient status and checks of Adverse Events (AEs) and Serious Adverse Events (SAEs).
- Site liaison (newsletters etc).
- Regular monitoring meetings with our CRAs to discuss study progress, any general problems occurring and their solutions.
- Monitoring (reports and reaction to reported problems and questions, adherence to study visit schedule, recruitment speed and on-site problems).
- Study logistics such as sample transport, drug and material supplies.
- Investigator's fee management.
- Hospital contracts.
CONTACTS WITH THE SPONSOR
For each trial, a specific project leader and a second in command are named.
The project leader regularly sends updates on patient status, site visit reports and other documents to the sponsor as required and plans meetings when necessary. He is the main contact person for clinical, scientific and budget aspects of the clinical trial.