Clinical Trials
conduct of national and international studies

planning
development plan, study design, statistical plan, protocol, CRF design including printing

medical writing
study protocol, study report, publication, literature review, expert report, responding to deficiency letter, scientific fact file, trainer's manual, oral presentation, slide kit, investigator's brochure

project management
investigator recruitment, execution of the study according to study protocol, ICH-GCP, CPMP and national legislation, status reports within 24 hours (at any time), application for approval from relevant authority, submission to ethic committee

monitoring and auditing
preparation of study material, on-site and in-house monitoring on the basis of Standard Operating Procedures (SOP) and ICH-GCP, study-specific check list, in-house and on-site auditing, SDV (source data verification)

data management
database development, data entry and verification, double data entry, data validation and query management, CRF and query tracking, coding of medication, diseases and adverse events, data transfer, database quality assurance, remote data entry

biometrics
statistical design, sample size determination, computer-based randomisation, analyses plans, statistical analysis, meta-analysis, consulting