We decrease the administrative burden of the sites, improving the timelines and the data quality, while being fully integrated into the clinical research team.
- Provide conditions for conducting clinical trials in accordance with the Study Protocol, the guidelines for Good Clinical Practice of the International Conference on Harmonization (ICH – GCP) and national laws and regulations
- Provide duly completion of the Study documentation (Case Report Forms, temperature logs, patient logs, Drug accountability logs, etc.).
- Enter data in IWRS, eCRF and other systems for the specific study.
- Maintain the Investigator Site File and Patient binders for the study
- Proper handling, allocating and reporting on the study drugs
- Assist for timely reporting of adverse events to Sponsor/CRO
- Act as a main line of communication between monitors, CRO and site
- Assist in archiving of study documentation in compliance with the applicable regulations