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As we navigate 2025, the biometrics landscape is undergoing transformative changes that sponsors must understand to maintain competitive advantage. From AI integration to regulatory pressures, here's what you need to know to prepare your clinical development programs for success.
The integration of AI and generative AI is no longer optional—it's becoming a core capability across biometrics functions. With generative AI alone expected to create $60-110 billion in value across life sciences, sponsors must focus on:
● Advanced Statistical Analysis: AI algorithms are automating complex statistical analyses, reducing timelines by up to 40%
● Predictive Analytics: Machine learning models are improving study design optimization and patient enrollment predictions
● Quality Control Automation: AI-powered systems are identifying data anomalies in real-time, preventing costly delays
● Protocol Optimization: AI is enabling dynamic protocol design based on real-world evidence and historical data
EXPERT INSIGHT: While AI adoption accelerates, many sponsors find success by combining internal oversight with specialized external expertise. Experience across 2,200+ biometrics projects shows that a hybrid approach—keeping strategic leadership in-house while leveraging specialized FSP resources for execution—often delivers optimal results without requiring massive infrastructure investments.
A groundbreaking partnership between AstraZeneca and BenevolentAI demonstrates the transformational potential of AI in target identification. Initiated in 2019, the collaboration has delivered five novel targets to AstraZeneca's portfolio across multiple therapeutic areas, including chronic kidney disease and idiopathic pulmonary fibrosis. The collaboration integrates BenevolentAI's proprietary AI platform with AstraZeneca's disease expertise, allowing scientists to interrogate underlying disease mechanisms and rapidly identify novel targets at scale. In 2023, new preclinical data on an AI-generated target (Serum Response Factor) for idiopathic pulmonary fibrosis was presented, showcasing successful biological validation of a computationally identified target.
The regulatory environment continues to adapt to new technologies and methodologies. Key developments for 2025 include:
● Expanded acceptance of real-world evidence in submissions
● New guidance on AI/ML in clinical development
● Enhanced focus on data integrity and cybersecurity
● Streamlined pathways for innovative trial designs
● Increased alignment between FDA, EMA, and PMDA requirements
● Standardized approaches to digital endpoints
● Unified frameworks for decentralized trials
● Common standards for AI/ML validation in biometrics
2023 2024 2025
|---------------------------|--------------------------|
FDA Draft EMA Digital FDA
Guidance on Health Framework Guidance on Complex
Digital Implementation Innovative Trial Design
Endpoints With AI Components
The evolution of data management practices is fundamentally changing how sponsors approach clinical trials:
Year | Average Data Points per Subject | Total Data Volume per Phase III Trial |
2020 | 3.5 million | 1.7 terabytes |
2022 | 6.2 million | 3.4 terabytes |
2024 | 9.4 million | 6.8 terabytes |
2025 | 11.2 million | 9.3 terabytes |
● Cloud-Native Solutions: Migration from legacy systems to cloud-based platforms for real-time data access
● Integrated Data Ecosystems: Breaking down silos between EDC, CTMS, and eTMF systems
● Automated Data Cleaning: ML-driven algorithms reducing manual cleaning by 60-80%
● Risk-Based Monitoring: More sophisticated approaches to centralized statistical monitoring
In 2018, PAREXEL and SHYFT Analytics (now part of Medidata) formed a strategic partnership to enhance real-world evidence generation for biopharmaceutical clients. Their QUANTUM Real-World Evidence platform demonstrated the ability to generate robust "submission-ready" studies 92% faster than industry standard. This partnership enabled large-scale analyses including cohort modeling, trial feasibility assessment, and observational studies, exemplifying how technology partnerships are streamlining traditionally time-consuming biometrics workflows.
The biometrics workforce is facing a significant transformation:
Skill Area | 2020 Importance | 2025 Importance | Change |
Statistical Programming | ★★★★★ | ★★★★ | ▼ |
Machine Learning | ★★ | ★★★★★ | ▲▲▲ |
Cloud Computing | ★★ | ★★★★ | ▲▲ |
Real-World Data Analysis | ★★★ | ★★★★★ | ▲▲ |
Regulatory Knowledge | ★★★★ | ★★★★★ | ▲ |
Project Management | ★★★ | ★★★ | ◆ |
● Hybrid Skill Sets: Demand for professionals who combine statistical expertise with data science capabilities
● Digital Literacy: Every biometrics professional needs foundational understanding of AI and automation
● Strategic Thinking: From tactical execution to strategic business partnership
● Continuous Learning: Rapid technological evolution requires ongoing skill development
TALENT STRATEGY: The growing complexity of biometrics skills makes traditional in-house staffing increasingly challenging. Many sponsors are discovering that Functional Service Provider (FSP) models provide access to specialized expertise without the overhead of permanent hiring. This is particularly true for SAS programming—a resource-intensive function that often requires significant scaling during peak periods of development. Leading FSP providers maintain dedicated talent pools with rapid onboarding capabilities, enabling sponsors to flexibly expand or contract resources as pipeline demands fluctuate.
Sponsors are rethinking their biometrics operating models:
Hybrid Approaches
● Maintaining core competencies in-house while leveraging external expertise
● Functional Service Provider (FSP) models for flexibility
● Strategic partnerships for specialized capabilities
● Outcome-based contracting with biometrics providers
IMPLEMENTATION INSIGHT: Experience from over 2,200 successful biometrics projects demonstrates that effective FSP partnerships depend on robust onboarding and integration processes. The most successful implementations feature dedicated communication channels, shared knowledge repositories, and seamless integration with sponsor systems. For SAS programming specifically—often the most resource-intensive component of biometrics operations—a specialized FSP model typically delivers 30-40% greater cost efficiency while maintaining or improving quality and timelines.
● Cost efficiency versus strategic control
● Access to emerging technologies
● Speed of adaptation to change
● Global reach and local expertise
Experience with leading biotechs highlights the power of strategic hybrid models. One 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. The company maintained strategic control while accessing specialized expertise exactly when needed.
In another case, 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. The model provided immediate access to specialized programming expertise while maintaining consistency in deliverables and regulatory compliance.
The shift toward decentralized approaches is impacting biometrics:
Therapeutic Area | Digital Endpoint Adoption | Key Applications |
Neurology | ★★★★★ | Mobility, cognition, sleep patterns |
Respiratory | ★★★★ | Breathing patterns, oxygen saturation |
Cardiovascular | ★★★★ | ECG, activity levels, blood pressure |
Metabolic | ★★★ | Glucose monitoring, dietary tracking |
Oncology | ★★ | Activity levels, PROs, symptom reporting |
● Remote Data Collection: New methodologies for ensuring data quality from diverse sources
● Digital Endpoints: Statistical validation of novel digital biomarkers
● Patient-Generated Data: Integration and analysis of wearable device data
● Hybrid Trial Designs: Balancing traditional and decentralized elements
As AI becomes ubiquitous in biometrics, sponsors must address:
● Algorithmic Bias: Ensuring fair representation across demographics
● Transparency: Maintaining explainable AI in regulatory submissions
● Data Privacy: Protecting patient data in AI-driven analyses
● Governance Frameworks: Establishing oversight for AI implementation
Medidata has developed Simulants, a pioneering synthetic data tool designed to deliver insights from historical clinical trial data while protecting patient privacy and intellectual property. This technology has been validated to meet regulatory and privacy constraints, enabling developers to explore patient populations, endpoints, and trial outcomes without compromising sensitive data. The system leverages Medidata's repository of data from over 30,000 trials and 9 million patients, addressing one of the fundamental challenges in AI development for clinical trials: access to high-quality, diverse training data that meets stringent privacy requirements.
The financial implications of modernized biometrics approaches are substantial:
Investment Area | Implementation Cost | Potential ROI | Timeframe |
AI-Powered Analytics | $2-5M | 300-450% | 18-24 months |
Integrated Data Systems | $3-7M | 200-300% | 24-36 months |
Decentralized Trial Infrastructure | $1-3M per study | 150-250% | 12-18 months |
Biometrics Talent Development | $0.5-1M annually | 275-350% | 18-30 months |
AstraZeneca partnered with analytics firm ZS to enhance clinical development through real-world evidence (RWE) for a pipeline asset in atherosclerotic cardiovascular disease (ASCVD). By analyzing electronic health record data, they researched how the rate of secondary Major Adverse Cardiovascular Events (MACE) varies between patient groups. The team leveraged a federated EHR analytics platform to answer key questions that informed trial design, including how adjusting inclusion/exclusion criteria would affect projected patient cohort size. This approach helped optimize site selection and recruitment strategy.
To thrive in 2025's biometrics landscape, sponsors should:
1. Assess Current Capabilities: Conduct a gap analysis against emerging requirements
2. Develop a Digital Roadmap: Create a phased approach to technology adoption
3. Invest in Talent: Build teams with hybrid statistical and data science skills
4. Evaluate Partnership Models: Determine optimal balance of internal and external resources
5. Establish AI Governance: Implement frameworks for responsible AI use
6. Embrace Agility: Create organizational structures that can adapt to rapid change
STRATEGIC CONSIDERATION: For emerging and mid-sized biotechs, the dilemma isn't whether to outsource biometrics, but how to structure the relationship for maximum value. Leading organizations increasingly adopt mixed models—retaining strategic biostatistics leadership while leveraging FSP partnerships for specialized functions like SAS programming, CDISC implementation, and data management. This approach offers access to global regulatory expertise (FDA, EMA, PMDA) without the overhead of maintaining these specialized capabilities internally during variable demand periods.
Q2 2025 Q3 2025 Q4 2025 Q1 2026
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Capabilities Technology Talent Operational
Assessment Strategy Development Integration
- Gap Analysis - Build/Buy Decisions - Training Programs - Process Updates
- Benchmarking - System Selection - Strategic Hiring - Governance Implementation
- Vision Setting - Implementation Plan - Partnership Models - Performance Monitoring
The biometrics landscape of 2025 demands a strategic approach that balances innovation with regulatory compliance. As data volumes grow exponentially and regulatory expectations increase, sponsors who proactively address these trends will be better positioned to accelerate drug development, reduce costs, and ultimately bring life-changing therapies to patients faster.
The real-world case studies from industry leaders like AstraZeneca, BenevolentAI, PAREXEL, SHYFT Analytics, and Medidata demonstrate that AI-powered biometrics is no longer a theoretical future state but a present reality delivering tangible benefits. The collaborative pattern emerging across these examples suggests that partnerships between technology providers and pharmaceutical companies will continue to be a dominant model for implementing advanced biometrics capabilities.
Looking ahead, we can expect regulatory frameworks to evolve in response to these innovations, with clearer guidance on AI validation, synthetic data acceptability, and the use of real-world evidence. Organizations that invest now in the foundations of modern biometrics—data infrastructure, AI capabilities, and specialized talent—will have a significant competitive advantage in the increasingly complex and data-rich clinical development landscape of 2025 and beyond.
As with any transformation, the key lies in selecting partners with proven experience navigating these evolving terrains. Those with established track records supporting global regulatory submissions, flexible resourcing models, and deep therapeutic expertise will be invaluable allies on the journey ahead.
With 22 years of experience across 2,200+ successful global projects and 160+ NDA approvals from FDA, NMPA, and EMA, GCP ClinPlus offers unparalleled biometrics expertise. Our flexible engagement models—from strategic consulting to FSP and full outsourcing—are designed to adapt to your evolving clinical development needs. Our US leadership team brings 30+ years of global regulatory experience to every engagement, with specialized knowledge across oncology, gene therapy, rare disease, and other complex therapeutic areas.
Special Offer: We provide complimentary assessments of your protocol, analysis plan, biometrics resources, and vendor gaps—helping you identify the optimal resourcing approach for your unique situation.
Contact: Suling Zhang, VP of International Operations and Business Development
Email: suling.zhang@gcp-clinplus.com
Phone: +1 609-255-3581