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Data Management

OCT works 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 are among the most vital parts 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 regulations of data-feeding outlined by the Russian Ministry of Health, FDA and EMA and local regulating bodies in the countries we run our operations.

Clinical Data Management is very critical in clinical research. The main goal of all data management procedures is to provide statistically sound data with the minimum number of errors and missing values. To achieve that we use various software solutions, which, combined with best practices, help to essentially improve and increase data quality.

Anastasiia Zaitseva
Head of Data Management

Web-based process
Our web-based process implies that data is entered directly from study sites into 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 timeframes of data processing.

Paper-based process

For smaller studies, and based on a sponsor’s requirements, we can sometimes follow a paper-based approach. All steps of entering data into the database are provided in full compliance with applicable standard procedure.

We perform Data Management using advanced eClinical solutions based on a variety of validated EDC, including our own:

• Electronic Data Capture in full compliance with CFR 21 Part 11

• The software is fully validated

• Built-in system of randomization

• Module for planning and conducting the inventory of study drugs

• Data quality control with the use of automated and manual checks

• Coding terms using MedDRA and WHODrug Global

• Import of data from external sources

• Generation of standard and custom reports

• CDISC compliance

 

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