Press Releases
CD BioSciences is Ready to Provide Clinical Data Management Service
The clinical and scientific team of CD BioSciences, a US based supplier of one-stop clinical trial services, has announced to provide global scientists with clinical data management service, empowering their capabilities in clinical data management, analysis and reporting, and thereafter, accelerating their drug development programs.
Clinical data management (CDM) is a critical process in clinical research especially when collecting and managing research data in accordance with regulatory standards. It is involved in all stages of clinical trials and carried out under two standards created by the Clinical Data Interchange Standards Consortium (CDISC): Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG in short, mandated for use by FDA) and Clinical Data Acquisition Standards Harmonization (CDASH in short, a standard format to collect data across studies). CDM leads to the generation of complete and error-free data from clinical trials, and ensures to gather as much as of high-quality, reliable and statistically sound data for later analysis at appropriate cost as possible.
To maintain data integrity, the CDM process starts from clinical trial inception to completion, even at the beginning of protocol design. The subsequent steps in CDM process include case report form (CRF) design, CRF annotation, database set-up and design, data entry, validation, discrepancy management, medical coding, data cleaning and reporting. CDM could be customized or tailored made according to specific requirements, all contributing to the regulatory submission and approval of the new drug.
“A full range of clinical data management activities include data acquisition, abstraction/extraction, processing, coding, analysis, transmission, storage, privacy and quality assurance.” Says Helen James, Senior Scientist of CD BioSciences, “It’s crucial to choose the right CDM team especially when it’s concerned with how to conduct the CDM process and obtain reliable, accurate and high-quality research data.”
At CD BioSciences, the CDM team lays exclusive importance on the accuracy of clinical data. The team consists of clinicians, statisticians, programmers, data managers, and analytical scientists who have been serving in clinical trials back to 2004. That enables the team to provide a stand-alone or full-range of CDM solutions.
“Nearly 2 decades of experience in clinical trial development and data management easily makes a team stand out.” Adds Helen, “We’re ready to help tackle with complex CDM issues once given a chance.”
The company claims to provide clinical data analysis and reporting services across all clinical phases and for all therapeutic areas. To learn more about what CD BioSciences could help in clinical trial development from study design to regulatory approval, visit https://www.cd-biosciences.com/.
About CD BioSciences:
CD BioSciences was founded in the U.S. in 2004. It provides a full suite of services covering the entire clinical trial lifecycle, including bioanalytical lab testing, clinical pharmacology, first-in-human (FIH), proof of concept (PoC), early phase trials, later phase trials, clinical data management, data analysis and reporting. The company also provides biostatistics services with no therapeutic area limit. The company claims to be customer-oriented and would like to continuously support both academic and industrial scientists in their clinical trial development.
