Email:
global@GCP-ClinPlus.com
Founded in 2003, we are an international biometrics service provider with strategic offices acrossthe United States and Asia, serving the needs of pharmaceutical and biotech companies worldwide.
Our biometrics teams bring together the best talent from across the globe:
● 200+ data statistics professionals across domestic and international locations
● 500+ clients served across pharmaceutical, biotech, and medical device sectors
● 2,200+ successful projects completed, supporting numerous breakthrough therapies
● US leadership team with 30+ years of industry experience, including veterans from Novartis, Celgene, AstraZeneca, and other leading pharmaceutical companies
● Core team averaging 17+ years of experience in biometrics and clinical research
● 31%+ employees with 5+ years of experience:
○ 2/3 internally trained
○ 1/3 from mulnational companies → Ensuring stability & growth
● 30+ expert teams built over 7 years, maintaining industry-leading expertise
● Therapeutic expertise spanning oncology, gene therapy, hematology, ophthalmology, rare disease, metabolism, and many other areas
● 20 years of close collaboration with top statistical experts from five leading universities
● Former FDA statistical review experts providing guidance and support
● CDISC Gold Member with 12 years of experience in CDISC submissions to FDA, EMA, and PMDA
● Active participant in CDISC guideline creation
● Starting over 150 projects annually
● Industry leader in implementing centralized monitoring and inspection
● Assisted in the launch of over 160 products
● Domestic leader in implementing centralized monitoring and inspection
● High customer satisfaction, with repeat orders exceeding 67%
● Quarterly customer satisfaction tracking, ensuring prompt resolution of communication and quality issues
Our US biometrics leadership team maintains frequent interactions with regulatory authorities and possesses rich FDA submission experience. We provide end-to-end support from strategic planning and protocol design through submission, leveraging our deep understanding of regulatory requirements and statistical methodologies.
Our biometrics team ensures your clinical trial data is complete, accurate, and reliable through:
● Expert Clinical Data Management: Ensuring data integrity throughout your trial
● Robust Data Cleaning and Validation: Optimizing collection and analysis processes
● Regulatory Compliance: Ensuring trial data meets industry standards and regulatory requirements
Our statistical experts provide critical input for:
● Sample Size Calculation: Determining optimal participant numbers for statistical significance
● Randomization: Developing schedules to ensure unbiased subject assignment
● Study Design: Creating robust methodologies with appropriate statistical models
Our advanced SAS programming capabilities transform complex datasets into meaningful insights:
● Statistical Analysis: State-of-the-art algorithms for processing, organizing, and analyzing trial data
● Regulatory-Ready Deliverables: Production of compliant tables, listings, and figures for submissions
● Actionable Insights: Clear visualization and interpretation of complex clinical data
● Enterprise-Level Infrastructure: Robust, secure SAS environments supporting global operations
● Efficient Solutions: Modular programming frameworks and automated reporting tools that accelerate timelines
We help streamline your clinical development through:
● Faster Data Collection and Analysis: Optimizing processes for quicker trial timelines
● Early Issue Identification: Providing timely data analysis to minimize delays
● Technology-Driven Solutions: Leveraging proprietary platforms for data management, randomization, modular programming, and automated reporting
● 5+ invention patents and 26 software copyrights
● Proprietary platforms for data management, randomization, modular programming, automated reporting, and project management
● Certified in multiple EDC systems including Medidata Rave, Coder, Builder, and RTSM systems, with an independent URL
● CRF & logic check template library built from 2,200+ projects
● Certified in 10+ leading domestic and international EDC systems
● Project data query & analysis platform developed from 2,200+ projects
● Knowledge management platform with 1,000+ case studies of lessons learned
Our commitment to quality is reflected in:
● Comprehensive training system with a standardized course library of 1,000+ courses, enabling on-demand learning and technical support
● International SOPs & Templates: Developed from expertise with top 5 global pharma companies
● Robust Process Systems: Refined through 20+ years of domestic and international audits, inspections, and reviews
● High Customer Satisfaction: 67%+ repeat business rate
● Quarterly Satisfaction Tracking: Ensuring prompt resolution of any issues
● Dedicated key account managers and delivery teams, backed by client agreements for stable and reliable delivery
● Strong financial backing to drive future growth
We understand that each sponsor has unique needs. Our flexible engagement models include:
● Full-Service Outsourcing: End-to-end biometrics support
● Strategic Consulting: Expert advice at critical junctures
● Functional Service Provision (FSP): Dedicated team extensions
● Hybrid Approaches: Customized combinations of the above
Over a decade-long partnership with a growing biotech company, our biometrics team provided strategic and operational support across their entire development portfolio. This collaboration:
● Saved the company over $30 million in development costs
● Supported 3 successful FDA approvals
● Enabled efficient scaling of their biometrics capabilities as the company grew
● Provided flexible resourcing during periods of peak activity
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