Resource Library

02.12.2022

Clinical Data Management: What Is It For?

Clinical Data Management (CDM) was established as a result of a growing request from pharmaceutical companies to speed up the drug development process and to improve data quality, as well as from regulatory authorities for the implementation of quality procedures to ensure robust data for further evaluation. Data Management (DM) is an important part in clinical trials, which leads to the obtaining of holistic, high-quality and statistically-valid data. In this way, the time from drug development to their entry into a market is essentially reduced.

CDM is the process of collecting, cleaning and managing clinical data in compliance with regulatory standards. The main goals of CDM are to:

  • Collect all necessary data for statistical analysis and evaluation
  • Minimize the number of errors and missing data

To achieve these goals, specific software must be used and there must be strong adherence to best Data Management practices and clear procedures.

Software in Clinical Trials

The Electronic Data Capture system for the collection of clinical data must be compliant with CFR 21 Part 11 and have audit log, access rights differentiation, quality checks for data entry, discrepancy management processes, and other features which simplify the collection and management of data.

At OCT Clinical we propose that our clients use our software with EDC and IWRS together on one platform – Data MATRIX EDC/IWRS. The system is suitable for use in I-IV phase studies, including BE and post-marketing studies. To track study medications and to minimize supply chain costs, we can set up a Trail Supply module which is integrated into the EDC/IWRS. All system products are fully validated and compliant with regulatory requirements.

CDM procedures

To provide statistically-valid data at the end of the trial, all steps of CDM should be clearly defined at the beginning of the study. A brief explanation of essential CDM steps is provided below:

1. Setup. Preparation of DM plans and CRF, database design and setup.

2. Validation of collected data. An extensive and critical process including the use of programmed checks, discrepancy management, medical data coding, and the reconciliation of third-party data and PV data.

3. Database lock and archiving. Strong procedures on the locking of electronic forms and data to ensure that there is no data manipulation during the final statistical analysis, and the preparation of final data archives for study sites and clients.

At OCT Clinical there are well-defined standard procedures for each step and process. All of them follow best practices and have passed numerous audits successfully.

CDM roles

Different roles can be included in different CDM procedures. All CDM members must have relevant qualifications and experience. Basic roles we have in the OCT DM department are:

  • Clinical Data Manager
  • Data Management Assistant
  • Database Designer
  • Datasets Developer
  • Database Administrator
  • Medical Data Coder

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It is impossible to obtain reliable study results without carefully collected and cleaned data. That is why Data Management is integral to and crucial for clinical trials. If you would like to learn more about CDM and entrust your study to a team of professionals, please contact us at info@oct-clinicaltrials.com.

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