CIS IS A CONTRACT RESEARCH ORGANIZATION
WE OFFER SERVICES IN THE AREA OF:
Qualified Person according to Directive 2005/28/EC Article 10, respectively 2001/20/EC, Article 13.
preparation/adaption of Standard Operating Procedures (SOP),
training of project leaders,
training of auditors,
training of monitors (GCP),
training of investigators (GCP),
feasibility analysis of projects or clinical trials,
integrated medical-statistical reports (ICH),
CDT medical parts (2.5, 2.7 and 5), Expert Reports,
Quality Assurance, GxP.
CIS Clinical Investigation Support has a broad experience in conducting audits in all major areas of clinical research. CIS has performed audits in more than 30 different European and non-European countries. CIS considers quality assurance services not only as an instrument to increase or maintain quality but also to reduce costs.
CIS has performed or is performing quality assurance activities for more than 20 companies, most of which have trusted CIS repeatedly with various projects.
References for Management Support in R&D,
Consulting for Drug Development, Protocols, CRFs, Reports, etc.) for more than 30 international companies.
Integrated Medical-Statistical Reports (ICH), Application for Clinical Trial Authorization and Expert Reports for more than 20 companies.
Registration Support has been performed for more than 10 international companies.
Company-Training incl. Training on the Job as on Good Clinical Practice, monitoring, auditing, logistics/organization of trials, protocol and CRF design, codification, randomization, statistics, blinding and Investigator-Training, as well as Lectures and Seminars for several companies and institutes.
More than 20 years experience in planning and managing of clinical Phase-I studies.
Risk management and pharmacovigilance.