Consulting, research, literature review, hypothesis generation, study protocol, sample size calculation, creation of CRFs, patient information, cost calculation, contracts, EudraCT-No.
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.
Close-out of study-sites, data management, data validation, statistical programming, SPSS or SAS analysis, presentation of data as tables and graphs.
Writing of publications for peer-reviewed journals and for presentation at conferences.
Saliva Lab Trier
Our laboratory can analyse the following biomarkers: 17-OH progesterone, alpha-amylase, androstendione, cortisol, cotinine, C-reactive protein, DHEA, DHEA-S, estradiol, estriol, estone, IL-1 Beta, IL-6, melatonin, progesterone, secretory IgA, testosterone, and uric acid.
Other biomarker analysis can also be performed. Please contact us with your specific request. We are happy to advise our clients from the very beginning on project planning and/or sample collection and storage. Your questions will be dealt with in a swift manner based on our experience and expertise.
Logistics, project and time management, study coordination, study nurses, monitoring, randomization, data acquisition, query management, statistical analysis plan, reporting obligations to EC and authorities, pharmacovigilance.
As per ICH E3 and CONSORT interpretation, appendices, information to EC and authorities, support with archiving.
Education, workshop, conference
Planning and organization, recruitment of experts, implementation, publication, TSST training courses.