For our clients and partners, we:
- started and successfully completed 255 projects
- created 585 unique documents
- performed 48 literature searches in multiple languages and that resulted in 69 clinical and preclical sections of CTDs (common technical documents) in EAEU format
- created and validated our own electronic CRF (OpenClinica-based) and started 25 eCRF projects
- completed 39 statistical analyses and wrote 21 clinical study reports ready for regulatory submission
- provided rationale and calculation of 80 sample sizes, prepated 47 statistical sections for protocol and 24 statistical analysis plans
- performed 23 expert reviews of registration dossier documents
- provided 142 consultations in drug development and registration strategy.
Our documents, reviews and reports were successfully submitted in 10 countries in and outside of EAEU.
12 projects were "full-cycle" ones - started from the study concept, made their way through development of protocol, IB and CRF, supported by data management throughout the study conduct and successfully ended in statistical analysis with clinical study report finalization.
Year 2018, here we are, ready for new accomplishments and new starts!
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