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CNS Data
Management
Data Management
with Precision
for Powerful
Outcomes
At CRC, we bring precision, consistency, and scientific integrity to every stage of CNS clinical trial data management. From CRF design through database validation and lock, our team ensures that your data is accurate, compliant, and ready for analysis.
Moreover, with rigorous quality control embedded throughout the process, we safeguard data reliability and traceability. As a result, this establishes a strong foundation for statistical interpretation and regulatory submission. Our goal is simple: to deliver data you can trust and insights that accelerate progress.
Data Integrity
You Can Depend On
Accurate data drives confident decisions. Our team captures and validates data accurately from start to finish. We provide a consistent team that remains with your trial throughout its duration, ensuring no disruptions and a seamless experience.
Our expert managers, builders, and programmers are precisely matched to your trial’s needs, fostering an environment that empowers efficiency from CRF design to database lock. In addition, we partner closely with sponsors, clinical sites, and vendors to maintain end-to-end visibility. This collaboration enables real-time issue resolution and consistent communication. Our cross-functional teams are deeply integrated to enhance data flow and accuracy throughout your trial’s lifecycle.
Our Data
Management Services
01.
CRF Design & Validation
Our custom Case Report Forms (CRFs) are designed to capture relevant data points efficiently and accurately, tailored to your study’s specific requirements and the nuances of CNS studies while adhering to CDISC standards. We leverage our eCRF library and our familiarity with CNS endpoints to ensure high-quality and reliable data is collected.
02.
Database Build & Management
With in-house expertise, our team can work with any preferred electronic data capture (EDC) platform. Our certified builders, fully accredited for Medrio and Rave EDC in-house database builds, recommend the best solutions for your trial in the most trusted technologies in the industry. We manage data integrations, complex study designs, and develop secure, compliant databases. Sponsors benefit from faster access to clean, validated data in a secure environment and real-time visibility that supports confident and timely decisions.
03.
Quality Control (QC)
We build quality into every phase. CRC’s data management process includes ongoing QC checkpoints to ensure data accuracy from collection to final database lock. We maintain 98% data cleanliness at Last Patient Last Visit, facilitating a streamlined and efficient database lock process. This commitment to precision drives reliable outcomes and builds sponsor confidence.
04.
Proactive Risk Identification & Mitigation
Our team is proactive in identifying potential risks early in the data management process. We implement tailored strategies to mitigate these risks, ensuring the integrity and reliability of your clinical trial data.
Built for Compliance.
Designed for Clarity.
CRC’s data management practices meet regulatory expectations, including FDA 21 CFR Part 11, ICH-GCP, and GDPR requirements. We validate and audit our systems to ensure compliance, traceability, and data protection.
Our Data Management team collaborates with Biostatistics, Statistical Programming, and Rater Services from protocol optimization and subject eligibility review to database closure and reporting. This proactive, transparent approach transforms data management from a transactional service into a strategic advantage that facilitates smooth transitions to SDTM/ADaM dataset creation for analysis.
Data Review Process
Our team engages in constant data review and discrepancy identification, generating and resolving queries as needed and ensuring all data inconsistencies are promptly addressed. We maintain rigorous data integrity through frequent coding reviews by the medical monitor, timely reconciliation of external vendor data, and continuous oversight of safety listings. Our commitment extends to identifying data trends, implementing solutions, and ensuring timely review and closeout of all database queries.
01.
Medication, Medical History, & Adverse Event Coding
Our systematic coding process supports the consistency of data across different datasets and enhances the accuracy and reliability of the data analysis, ensuring alignment with study objectives and regulatory standards.
02.
SAE Reconciliation & Discrepancy Management
We prioritize rigorous reconciliation to manage Serious Adverse Events (SAEs) and resolve discrepancies for consistent safety reporting.
03.
Third Party Vendor Data Management
Our team expertly manages the receipt and reconciliation of third-party vendor data, ensuring seamless integration and consistency across all data sources. We are proactive in the setup of data transfer agreements with each vendor as early in the process as possible, ensuring timely receipt of external data for project team needs.
04.
Metrics Reporting
Data accessibility is key in all clinical trials. Our transparent data cleaning processes and comprehensive metrics reporting ensure that sponsors are fully informed of their data’s status throughout the clinical trial. A clean-as-you-go strategy regularly evaluates the state of all the data preparation aspects using a customizable Clean Subject Report.
get in touch
Ready to partner with a CNS CRO that turns complexity into clarity?
Contact CRC to learn how our data management expertise can enhance your next neuroscience study.