Email:
global@GCP-ClinPlus.com
GCP ClinPlus' Functional Service Provider (FSP) model delivers specialized biometrics expertise that seamlessly integrates with your organization. Our approach provides the flexibility to scale resources up or down as your clinical development pipeline evolves, eliminating the overhead of permanent staffing while maintaining the highest quality standards.
With 22 years of experience supporting over 2,200 successful projects, our FSP solutions have helped companies of all sizes optimize their biometrics operations through strategic resource allocation.
● Reduce overhead costs by eliminating non-productive time
● Convert fixed costs to variable for better budget management
● Avoid recruitment expenses for specialized technical roles
● Eliminate training costs through access to pre-qualified experts
● Rapidly scale up during peak periods (submissions, interim analyses)
● Scale down during quiet periods without difficult staffing decisions
● Address specialized needs without long-term commitments
● Adapt to changing portfolio priorities with agile resource allocation
● Access specialized knowledge without lengthy recruitment
● Tap into therapeutic area expertise for complex studies
● Leverage regulatory experience from FDA, EMA, and NMPA submissions
● Benefit from cross-industry best practices and lessons learned
● Maintain knowledge continuity with dedicated resources
● Ensure consistent quality through standardized processes
● Preserve institutional knowledge despite program changes
● Enable focus on strategic priorities while delegating operational tasks
GCP ClinPlus provides functional resources across the full spectrum of biometrics:
● Statistical methodology development
● Protocol and SAP authoring
● Randomization design
● Statistical analysis and reporting
● CDISC dataset creation (SDTM/ADaM)
● TLF programming
● Efficacy and safety analysis implementation
● Integrated summary datasets (ISS/ISE)
● Database setup and maintenance
● Data cleaning and query management
● External data reconciliation
● Medical coding
● Protocol development
● Clinical study reports
● Regulatory submission documents
● Publication support
Our proprietary onboarding process ensures FSP team members integrate smoothly with your organization:
● Comprehensive knowledge transfer of systems and standards
● Dedicated integration manager to oversee transition
● Progressive responsibility approach to ensure quality
● Communication framework aligned with your preferences
Our FSP model is supported by a comprehensive infrastructure:
● Experienced line management for technical oversight
● Quality assurance processes to maintain deliverable standards
● Knowledge sharing networks across therapeutic areas
● Project management support for optimal resource allocation
We implement clear performance metrics to ensure accountability:
● Key performance indicators aligned with your priorities
● Regular performance reviews to ensure quality and timeliness
● Continuous improvement initiatives based on metrics
● Transparent reporting on resource utilization and outputs
Our global team structure provides multiple advantages:
● Follow-the-sun workflow for accelerated timelines
● Cost-efficient resource allocation across regions
● Local expertise for regional regulatory requirements
● Business continuity through geographic diversification
A mid-sized biotech specializing in RNA-targeted therapeutics adopted a hybrid approach—maintaining core biostatistics leadership in-house while partnering with GCP ClinPlus for execution. This model supported three successful FDA NDA approvals with zero statistical errors, while achieving approximately $30 million in cost savings compared to building equivalent capabilities internally.
A US subsidiary of a global ophthalmic pharmaceutical company utilized GCP ClinPlus' SAS programmer FSP services to manage workload fluctuations during peak trial periods. This approach allowed them to efficiently scale their biometrics team without permanent headcount costs—expanding capacity during critical submission preparation phases and reducing it during quieter periods.
Our proven implementation methodology ensures successful FSP partnerships:
● Evaluate current processes and systems
● Identify resource requirements and skill gaps
● Define performance metrics and quality standards
● Establish communication frameworks
● Select and onboard appropriate team members
● Transfer knowledge of systems and standards
● Implement governance structure
● Establish performance monitoring framework
● Deliver services according to agreed standards
● Monitor and report on performance metrics
● Conduct regular governance meetings
● Implement continuous improvement initiatives
● Analyze resource utilization patterns
● Identify efficiency opportunities
● Implement process improvements
● Refine resource allocation strategy
Contact us today for a complimentary assessment of your biometrics resources and discover how our FSP model can help you achieve greater flexibility, cost efficiency, and quality in your clinical development programs.
Contact: Suling Zhang, VP of International Operations and Business Development
Email: suling.zhang@gcp-clinplus.com
Phone: 609-255-3581