Statistical analysis of data
VCRO‘s Biostatistics and Data Management Department (BDMD) boasts 27 years of experience.
Members include senior department managers and four specialized groups.
VCRO’s Biostatistics and Data Management Team comprises seasoned SAS-programmers, including biostatisticians, programmers, data managers, and database developers. Their expertise spans ICH GCP, CDISC, local regulations, SOPs, and hundreds of data handling and statistical analysis projects, ensuring rigorous execution of clinical trial biostatistics, SAS statistical programming, EDC system construction and utilization, and data cleaning and management.
VCRO’s Biostatistics and Data Management Team ensures data accuracy and consistency by facilitating effective communication between clinical practitioners and report writers. We offer two EDC systems: VCRO EDC Lite, a user-friendly option, and Oracle Life Sciences Clinical One Cloud, recognized globally for complex trials. We uphold the highest standards at every step, providing professional support and assurance to our clients.
What we do
A successful clinical trial hinges on comprehensive data management and reliable statistical analysis.
VCRO’s BDMD team delivers these essential services, ensuring trial outcomes meet client expectations, optimize economic value, and provide robust support.
Clinical trial design and randomization
We offer comprehensive clinical trial study design services to ensure the scientific rigor and validity of your trial, encompassing sample size calculation (using nQuery Advisor, SAS), statistical methods research, randomization list generation, case report form (CRF) and user manual development, and subject diary design.
Data processing and validation
VCRO uses Oracle Life Sciences Clinical One Cloud for data management, aligning validation rules with study protocols. We employ SAS for data cleaning, management plan writing, query management, database operations, and protocol deviation tracking. VCRO also offers VCRO EDC Lite for streamlined electronic data capture in clinical trials.
Data coding
Clinical trial data formats can be tailored to client requirements or adhere strictly to CDISC submission standards mandated by the FDA. Data can be coded using standardized medical terminologies like MedDRA (Medical Dictionary for Regulatory Activities) and WHODrug (World Health Organization Drug Dictionary).
SAS Statistical Programming
VCRO ensures data integrity and reliability by utilizing the world-renowned SAS system for statistical programming, including data format standardization, subject data listings, and statistical analysis output (tables, graphs, and listings).
Statistical analysis and reporting
Statistical results undergo rigorous review by statisticians and consultants to ensure a robust foundation for clinical trial outcomes. This includes blinded review, pre-analysis meetings, SAP development, result consulting, and report writing.
Our characteristics
Recognizing the immense value of clinical trial data, VCRO’s BDMD team meticulously handles every data with utmost care and dedication.
VCRO utilizes senior expertise to maintain a regulatory-compliant process for diverse clinical trial data. We prioritize efficient interdepartmental communication and ongoing team training to stay current with advancements.
Standardized Operating Procedures (SOPs)
SOPs form the foundation of quality assurance at VCRO. Our SOPs, honed through hundreds of clinical trials, undergo regular review and updates to maintain alignment with the latest regulations and best practices.
Internal and external training
VCRO’s commitment to regular internal and external training, covering specialized and communication skills, keeps us at the industry forefront, adept at addressing challenges with comprehensive solutions.
Centrally managed SAS statistical programming tool
VCRO’s extensive and organized SAS statistical programming tools enable rapid and accurate data analysis, enhancing efficiency, shortening trial timelines for clients, and significantly reducing R&D costs.
Customized process
With the rapid development of clinical trial design, VCRO offers customized trial procedures, tailored to client needs and regulatory compliance, empower clients to address diverse demands effectively.
Our mission
Clinical trial involves intricate multi-step processes, requiring profound expertise and extensive experience to navigate each stage efficiently.
With nearly three decades of expertise, VCRO’s Biostatistics and Data Management team delivers tailored solutions for clinical trial success through collaboration, innovation, and a dedicated senior team, ensuring comprehensive support across all stages for client success.