Our team works predominantly with web-based data and provides full-service support through all phases of clinical development
Our team is dedicated to delivering high quality and accurate data within the desired timelines and tailored to the sponsors’ specific needs.
Given that Data Management and Biostatistics are the most vital part of conducting clinical trials, we place high importance on selecting the most advanced solutions and innovative approach to improve efficiency, reduce development costs and anticipate risks.
Our team works predominantly with web-based data and provides full-service support through all phases of clinical development. Results of both internal and external audits of our database have verified our compliance with all regulation of data feeding of the Russian Ministry of Health, FDA and EMA and local regulating bodies in the countries we run our operations.
Our web-based process implies that data is entered directly from study sites into the electronic CRFs (eCRFs). Error checking during data entry at sites allows for early detection and correction of errors including direct checking against source documents. This method helps to avoid additional costs associated with the double entry of data from paper-based forms into the web-database, as well as significantly reduce the timelines of data processing.
For smaller studies with up to 20 to 30 subjects, and based on Sponsor’s requirements, we sometimes apply paper-based approach. Data is collected in paper CRFs and entered into two separate data sets by two individuals, each working independently from each other. In case of inconsistencies, a reviewer selects the correct data in accordance with the source documents. Results of the review are saved and locked in in order to prevent any further changes.
We perform Data Management using advanced eClinical solutions based on our own EDC:
• Electronic Data Capture in full compliance with CFR 21 part 11
• The software is fully validated and complies with CDISC standards
• Built-in system of randomization
• Module for planning and conducting inventory of drugs and materials for a trial
• Independent double data entry from paper sources
• Data quality control with the use of automated and manual checks
• Coding terms using MedDRA and WHO Drug
• Import of data from external sources
• Generating standard and custom reports
• Statistical analysis of SAS and SPSS data
Our team of biostatisticians collaborates with medical writers and scientific experts with the purpose of securing appropriate interpretation of study results. OCT biostatistics experts provide support for complex statistical methodology and implementation of adaptive designs, clinical development plans and/or individual study protocols, including study design, sample size determination, biosimilar study designs and methodology, regulatory guidance for representation at meetings with global regulatory authorities.
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