— Data, Models and Insights —
Data Science Services
Our Data Science Services empower life sciences
teams to accelerate innovation, validate digital biomarkers, optimize protocols, and generate evidence for payers and regulators. From large-scale programs to focused, one-time projects, we deliver the expertise, tools, and flexibility to support your goals.
Our Expertise
We support the full digital biomarker lifecycle - from study design and device selection to regulatory submission.
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Feasibility assessments to ensure digital biomarker fit
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Signal processing and feature extraction from raw data
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Statistical validation of digital measures
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Endpoint definition and integration into study protocols
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Support through clinical development and regulatory submission
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Ensure every study starts on solid ground with expert statistical input and data-driven design strategy:​
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Protocol and study framework consultation
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Advanced trial methodologies, including adaptive and Bayesian approaches
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Sample size determination and power analysis
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Outcome and endpoint structuring with attention to hierarchy and interdependence
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Randomization planning and execution
Navigate complex regulatory landscapes with confidence, supported by technical guidance and proven quality standards:
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Strategic support for regulatory interactions and filings
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End-to-end development of submission-ready documentation
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Participation in independent data monitoring boards (IDMCs)
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Quality assurance for interim, final, or struggling trials
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Remediation strategies for studies in need of rescue
Translate your data into insight with a modern analytics toolkit designed for scientific impact:
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Predictive modeling and simulation to anticipate trial outcomes
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Customized statistical frameworks tailored to your protocol
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Expert interpretation to inform program decisions
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Interactive dashboards to visualize trends and variability
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AI and machine learning for enhanced signal detection
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Training and workshops to strengthen internal capabilities
Data
Syndication and
Insight Generation
Partner with us to access curated datasets or co-develop novel insights aligned with your innovation strategy.
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Access research-grade digital biomarker datasets curated for clinical relevance
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Collaborate on exploratory analyses to uncover new signals and patterns
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Co-develop novel algorithms and digital endpoints tailored to your needs
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Apply advanced modeling techniques to enhance sensitivity and reduce noise
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Accelerate innovation with real-world data designed for translational impact​​
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Flexible Engagement Models
Koneksa offers scalable, modular service models—from full platform support across multi-phase programs to targeted expert support for specific trial needs.
Whether you require embedded resources, rapid-turnaround analyses, or full-service strategic collaboration, our team flexes to fit your structure, timelines, and budget.
10+ years leading digital biomarker development and deployment
Purpose-built analytics platform for regulated research and real-world data
Cross-functional expertise in clinical operations, data science, and statistics
Trusted partner to top pharmaceutical and biotech companies
Transparent, collaborative, and scientifically rigorous approach
