Drug Development Services Phase II to IV - more than 40 Years of Experience in Clinical Research - more than 800 Clinical Studies under Biometrical Direction of idv.
Study Planning
Study protocols for all indications based on idv's special SOPs with modern, efficient biometrical procedures; operationalisation of clinical study objectives and implementation of biometrical procedures; design of CRFs; randomization; sample size calculation.
Data Management
Double data entry; extensive checks for completeness and plausibility by staff members with many years of experience; biometrical data clearing; blind review procedures - all in accordance with pertinent guidelines.
Data Evaluation
Careful pre-evaluation analyses according to ICH Guideline E9 ("Blind Review"), from simple observational studies to complex evaluations according to demands of regulatory authorities.
Writing of Clinical Study Reports
Writing of clinical study reports according to ICH Guideline E3 ready for submission to authorities (BfArM, EMEA, FDA); writing of publications according to CONSORT Guidelines - all this on absolutely solid biometrical background.
Audits
System audits; audits of study protocols, investigational sites, data management, biometry, Integrated Clinical Study Report.
Expert Reports
We prepare biometrical expert reports for submission to authorities (BfArM, EMEA, FDA) and to court.
Re-Analyses and Meta-Analyses
Re-Analyses of studies with negative outcome or studies rejected by authorities; sensitivity analyses; strategic analyses; re-interpretation; meta-analyses, combined evaluation and presentation of results from different studies.
Monitoring Supervision
Development of a study specific monitoring concept increasing the chances of success of the study, inclusive monitor training and investigator training, as well as study supervision.
Bioequivalence Studies
Demonstration of bioequivalence with our specially designed software; planning and evaluation within scope of biometrics; experience based on numerous publications.
Advanced Training, Certification
Seminars and workshops for staff members in the field of clinical research; certificates of qualification for submission to auditors and authorities.
Presentation at Authorities, Court
Biometrical defence of analyses and expert reports at authorities (BfArM, EMEA, FDA) and at court.
FDA CFR 21 Part 11 Standard
Installation of a validated system according to FDA 21 CFR Part 11: data entry, data management, biometrical evaluation, SOPs, tutorials, hardware (High Security PC).
