Service for contract studies and clinical trials
Our services
Planning
Consulting, research, literature review, hypothesis generation, study protocol, sample size calculation, creation of CRFs, patient information, cost calculation, contracts, EudraCT-No.
Preparation
Applications to authorities and ethics committees, notification of local authorities, registration of studies, and when necessary, recruitment of study sites/integration of networks, recruitment measures for patients, database construction and validation, data validation plan, investigator meetings, creation of TMF/ISF
Clinical Conduct
Logistics, project and time management, study coordination, study nurses, monitoring, randomisation, data acquisition, query management, statistical analysis plan, reporting obligations to EC and authorities, pharmacovigilance
Data-Analysis
Close-out of study-sites, data management, data validation, statistical programming, SPSS or SAS analysis, presentation of data as tables and graphs
Report
As per ICH E3 and CONSORT interpretation, appendices, information to EC and authorities, support with archiving
Publication
Writing of publications for peer-reviewed journals and for presentation at conferences
Education, workshop, conference
Planning and organisation, recruitment of experts, implementation, publication, TSST training courses