Clinical Data Management and Biostatistics (CDMB)

Clinical Data Management - Study planning, clinical data monitoring, data management, and biostatistics are the foundation for success in the drug approval process. DP Clinical builds upon this foundation with an excellent data management and biostatistics (CDMB) organization. Our CDMB services include development of protocols, and case report forms databases, data coding, data extraction, statistical analysis, and statistical report writing. Our focus on quality in these critical areas has resulted in a very low query rate as audited by clients and external organizations.

DP Clinical can provide you with an extensive array of CDMB skills for your projects. We have the ability to help you design your program from its inception, or we have the flexibility to work with your organization to strengthen programs that you already have underway. Our team is experienced in DZS Solutions ClinPlus® data management software, SAS® programming, MS SQL servers and Microsoft® Access. Our skills and services include:

• Data management, audit and documentation
• Developing data management plans
• Implementing data entry processing QC with built-in system checks
• Developing audit trails for all data-entry processes
• Medical coding using MedDRA, WHODRUG, or other industry-standard dictionaries as requested by study sponsor
• Database QA/QC
• Query/data discrepancy resolution
• Providing regular reports on query rates, and resolution statistics as well as  safety data for the Data Safety Monitoring Boards
• Developing clear and user friendly Case Report Forms and source documents
• Providing brief and explicable instructions for clinical staff use in data collection
• Preparing a study specific Data Management Plan (DMP) that includes:
• Designing, testing and validating clinical DBMS with programmed data edits including range check, logic checks and cross field edits
• Validating database management system prior to deployment for real time use
• Formulate study time lines for study completion

Biostatistics – DP Clinical can provide an array of statistical analysis including survival, multivariate modeling, logistic regression, and analysis of variance. We have experience in applying these analysis methods in research and development, manufacturing, and forensics applications. We can also provide the appropriate statistical reports to strengthen your research. Biostatistics services include:

• Clinical trial design/development of statistical analysis plan
• Statistical programming and validation
• Devise and validate randomization scheme
• Preparation and review of statistical reports and summaries
• Interim analysis
• Preparation of safety and efficacy summaries
• Statistical consulting
• Design and production of your statistical report