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Added value
- Close collaboration with project manager, CRAs, investigators and the Customer
- National and international monitoring
Project Management and Monitoring
Services
- Global project management.
- Study logistics start-up.
- Design of follow-up and progress status tables (regulatory documents, recruitment, monitoring visits, adverse events ...).
- Start-up, follow-up and center closure visits.
- Visit report writing in French or English.
- Management of Serious Adverse Events.
- Management of Data Clarification Forms.
- Close relationship with the investigational teams (hospital service, pharmacy, laboratory etc.).
MONITORING Quality data
Study excellence depends on quality monitoring, a vital step to obtain high quality data.
Global project management is performed by DELTA CONSULTANTS’ experienced and rigorous team of CRAs (Clinical Research Associates), providing knowledge and advice to satisfy Customer expectations. All projects are conducted following standard procedures assuring data of the highest quality.
Our Project Managers and CRAs are involved in every step of project management, for national or international studies (CRF, questionnaires, patient diary cards, queries, reports etc.), ensuring compliance with Good Clinical Practice recommendations (ICH) as well as local regulations and laws.