Clinical Study Design Preparation
Medical Writing
Consulting and Regulatory Support
Drug Safety and Pharmacovigilance
Project Management and Monitoring
Clinical Data Management
Biostatistics
Marketing Authorization
GMP Inspection Support
Clinical Supply Services and Logistics
Show All Services

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.

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.

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 with up to 20 to 30 subjects, and based on a sponsor’s requirements, we sometimes follow a paper-based approach. Data is collected on paper CRFs and entered into two separate data sets by two individuals, each working independently. 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 a  variety of validated cloud-based EDC, including our own:
• 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 the 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
• Generation of standard and custom reports
• Statistical analysis of SAS and SPSS data

Request a Callback