Clinical Data Management Service

Clinical monitoring of therapeutic drugs and medical procedures is an effective way to improve the level of medical care, so accurate clinical feedback must be provided to explain the monitoring results. Creative Biolabs provides customers with a full range of clinical testing services by establishing an interdisciplinary team consisting of medical technology experts, clinical analysis experts, pharmacologists and data analysts. You can use our services for clinical data management, statistical analysis and quality control.

Clinical Data Management (CDM)

CDM is a key step in clinical research and can help healthcare professionals extract high-quality, reliable, and statistically sound data from clinical trials. CDM can greatly reduce the time from drug development to market. With rich expertise, the CDM team of Creative Biolabs offers comprehensive CDM services to help customers maintain the quality standards of the CDM process, from the beginning of the project to all stages of clinical trials. During the trial, we regularly evaluate various procedures in the CDM, including the number of case report form (CRF) designs, database design, data verification, and difference management. In the current situation, there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of the product. By implementing data management tools that comply with regulatory requirements, our CDM team can meet these needs.

Fig.1 Clinical information network data management framework.¹

CDM Services at Creative Biolabs

• Database Designing. A database is a clinical software application designed to facilitate the execution of multiple studies for CDM tasks. These tools have inherent compliance requirements and are easy to use. "System validation" is conducted to ensure data security, during which system specifications, user requirements, and regulatory compliance are evaluated before implementation.
• Data Collection. Data collection is done using CRFs, which may be in paper or electronic form. In e-CRF-based CDM, researchers or designated personnel will log in to the CDM system and enter data directly on site. In the e-CRF method, there are fewer opportunities for errors and faster resolution of differences.
• CRF Tracking. The content entered in the CRF will be monitored by the Clinical Research Assistant (CRA) for completeness, and the completed CRF will be retrieved and handed over to the CDM team. The CDM team will track the retrieved CRFs and maintain their records.
• Discrepancy Management. This is also called query parsing. Discrepancy management involves reviewing discrepancies, investigating the cause, and providing written proof or declaring it as a solution that cannot be resolved. Gap management helps clean up the data and gather sufficient evidence for observed data deviations.
• Medical Coding. Medical coding helps identify and correctly classify medical terms related to clinical trials. To categorize events, a medical dictionary provided online was used.
• Data Verification. Data validation is the process of testing the validity of data according to protocol specifications. Write an edit checker to identify differences in the input data and embed it in the database to ensure data validity.

If you need or have questions about our clinical trial testing services, you can contact us for more details.

Reference

1. Tuti, Timothy, et al. "Innovating to enhance clinical data management using non-commercial and open source solutions across a multi-center network supporting inpatient pediatric care and research in Kenya." Journal of the American Medical Informatics Association 23.1 (2016): 184-192. Distributed under Open Access license CC BY 4.0, without modification.