OCT is happy to announce that we have won a bid for the data management activities and statistics for an open label study of the safety of the investigational drug in the treatment of transfusion-dependent iron overload in two years old and older aplastic anemia patients.
The Sponsor required a solution that would provide full database management, statistical analysis and report, as well as clinical study report. The current trial is a paper-based one (paper CRFs – Case Report Forms – are used during the study). OCT is sure to guarantee the full scope of activities performed by qualified specialists of the OCT Data Management department in due time. OCT takes proud in having our own Data Management Department in the framework of a mid-sized CRO. Several years ago our data management specialists have designed a Clinical Data Management (CDM) platform – OCT CDMS – a computerized system designed for the collection of clinical data in electronic format for use in clinical trials. The platform is fully compliant to 21CFR Part 11, FDA Guidelines for Computerized Systems used in Clinical Trials, European Regulations, etc. and compatible to CDISC ODM and CDASH standards.
Using this platform will provide the Sponsor with the required statistical and study report, as well as the full set of data management activities including:
• Data Management Plan development;
• Edit specifications;
• Database validation/ Consistency checks;
• CRF tracking;
• Double Data Entry;
• Data Queries generation;
• Data Queries resolution/ tracking;
• Coding concomitant diseases, AE & medications;
• Export Final Database for Statistical Analysis.
OCT CDMS is used in all phases of clinical research studies, either for early phase (phase I-II) studies or for late phase (phase III-IV) studies as far as for pharmacovigilance and postmarketing safety surveillance. The usage of OCT CDMS increases the data accuracy and decreases the time to collect data for studies of drugs and medical devices. The system is designed to support clinical database and typically provides the user with the ability to enter and retrieve information according to common user-specific criteria.
For statistical purposes, the database schema must be configured so that the dependent and independent variables are structurally situated to facilitate the use of statistical application programs. OCT CDMS application supports paper-based data management process and web-based data management process.
OCT is happy to collaborate with one of the most experienced key players on the pharmaceutical market: the Sponsor is a part of an international concern and a world leader in innovative pharmaceuticals, as well as generics and vaccines development. We honestly hope this first project will serve as a base for the subsequent collaboration.
