Comprehensive
Data Management
Services
At CRS, our data management team ensures high-quality data delivery across all phases of early drug development, from data collection and organization to validation and quality control.
We excel in working with both sponsor and CRS SOPs, seamlessly integrating sponsor-specific templates. Fully compliant with all relevant regulations, including CFR 21, part 11, our processes are validated by internal GAMP4 and GAMP5 standards.
Our data management services can be contracted as part of a clinical trial or as a stand-alone service, offering flexibility to meet your needs.
Our team manages 10 to 15 early-phase trials per year, handling and evaluating data in all relevant formats. We consistently meet project schedules while maintaining the highest quality standards in an efficient and cost-effective manner.
We have extensive experience with CDISC standards, holding Gold Membership status. Our data management processes adhere to the Study Data Tabulation Model (SDTM) standard, starting from the electronic Case Report Form (eCRF) to final data delivery.
We utilize the Medrio Remote Data Capture (RDC) system to maintain high data standards and quality. This customizable and efficient system includes medical coding using MedDRA (Medical Dictionary for Regulatory Activities) and the WHO Drug Dictionary. Our experienced Statistical Analysis System (SAS) programmers ensure compliance with CDISC standards, delivering accurate and reliable data management.
Our CRS biometrics team provides statistical analysis and programming, adhering to clients’ project requirements and ICH guidelines. We focus on process optimization to achieve maximum results, utilizing industry-standard software such as SAS, WinNonlin, and R.
The software used is fully validated, ensuring optimal focus and maximum results<br> at every trial phase. Our services include delivering trial data and reporting it in the form of electronic Common Technical Documents (eCTD), complying with international authority standards.
Software in Use:
At CRS, we are dedicated to delivering top-notch data management solutions tailored to the complexities of early drug development. Our experts ensure high-quality data delivery across all phases, from initial collection and organization to validation and quality control. Our adherence to regulatory standards, validated by GAMP4 and GAMP5, guarantees that your data management needs are met with the highest level of precision, allowing us to provide compliant and reliable services.
Whether you need comprehensive data management for your next clinical trial or a specialized stand-alone solution, CRS is here to support your objectives with unmatched expertise.
Reach out to discover how CRS can enhance your data management processes and drive your project to success. Our team is ready to provide tailored solutions and answer any questions you may have. Contact us to start your journey toward streamlined and efficient data management.