CLINICAL STUDY MANAGEMENT

 

Pharmacodynamic and pharmacokinetic studies

First in man clinical trials

Phase II-IV

Protocol writing, study design

Investigator Brochure

Study Feasibility

Site qualification and selection

Project management

Monitoring activities

Regulatory affairs

Archive (archive: TMF/ISF)

Data Management (eCRF, Ptient diary, central randomization, Images uploading)

Statistics reports

Wuality assurance

Central laboratory coordinating

Risk assessment

Study dedicated website

Training 

Investigator meeting