Key to efficient data analysis and reporting is proper standardized data. To help you achieve this DomainCDS has a strong process for data standardization. Our team of experts are adept at standardizing the data according to the regulatory standards with ease. We at DomainCDS understand what regulators expect when they review your submission. We ensure that the data is in a standard that complies with the FDA mandates and also in forms that are accurate, reliable and reproducible. We believe that standardized data help deliver operational benefits, allow efficient analysis.

Data standardization starts very early in the clinical trial life cycle, you need right expertise to make it right.

Our Services for Data Standardization:
 

• Design inputs for case report forms
• Full scale integration of CDISC standards
• Consulting services for migrating to CDISC standards from legacy standards
• CDSIC SDTM and ADaM implementation
• Independent Review/Validation of Datasets
• Annotated CRF, SDRG, ADRG, define.xml

Success of a clinical study depends on how well the study has been designed. Clinicians and Statisticians pay a vital role in the entire process. Our expert statisticians can help you design and analyze your studies. We have an experienced team of biostatisticians and programmers for creation and validation of analyzed datasets and data displays. Our biostatisticians have a desire for quality and implement the best process and approach to the client scenario to ensure the correct analysis without any complex processes and present the study results in the clearest possible way. We pride ourselves in taking personalized approach depending on the client’s need which in turn becomes a long-lasting relationship.

Our Services for Biostatistics and Statistical Programming:
 

• Statistical Analysis Plan
• Analysis Datasets and Metadata as per ADaM standards
• DSMB and Interim analysis
• Table, Listing and Figure Generation
• ISS/ISE Planning and Analyses
• Bioavailability/Bioequivalence Studies

Competence of the team is key to success for any organization. We help you enhance the skills of your team by providing customized and focused training based on your specific needs. The mission of talent development Program is to educate employees in developing the necessary methodological and skills to successfully apply statistical methods to the biological, biomedical and health sciences. In addition to enhancing their capacity to think creatively, we are determined to deepen their commitment to improving qualities that are essential for organizational success.

Our Training Portfolio:
 

• CDISC SDTM and ADaM Standards and Implementation
• Metadata (define.xml) and e-Submission
• Biostatistics and Programming
• SAS programming for Clinical Research
• Regulatory Guidelines and Industry Standards