Innovative Statistical Services for Clinical Trials
Transforming Statistical Science for Modern Clinical Trials
CIMS offers advanced statistical services that support the entire clinical development lifecycle, from initial dose-finding studies to late-phase confirmatory trials and regulatory submissions. Our team combines rigorous statistical methods with modern analytics, automation, and regulatory expertise to help sponsors design more effective studies, monitor trial progress, and derive meaningful insights from complex clinical data.
We extend traditional biostatistics by incorporating adaptive designs, dynamic data monitoring, and advanced analytics to enable faster, more confident decision-making while maintaining the highest standards of regulatory compliance.
Modern Trial Designs
We specialize in the design and implementation of innovative and adaptive clinical trial methodologies, including:
- Phase I/II dose escalation and dose optimization designs (e.g., BOIN, TITE-BOIN, CRM, and joint safety-efficacy frameworks)
- Seamless Phase I/II and Phase II/III designs
- Sample size re-estimation and adaptive interim strategies
- Benefit-risk-driven decision frameworks aligned with FDA expectations
These approaches support continuous learning throughout the trial while preserving statistical integrity and patient safety.
Joint Safety-Efficacy & Dose Optimization Analytics
Our statisticians apply structured frameworks to evaluate the efficacy-toxicity trade-off, moving beyond toxicity-only decision making. This includes:
- Utility and desirability-based dose optimization
- Exploratory joint modeling of safety and efficacy outcomes
- PK/PD and exposure-response integration
- Data-driven selection of recommended Phase II dose(s)
All joint modeling approaches are applied in a supportive and regulatory-appropriate manner, with final decisions guided by the totality of evidence and clinical judgement.
Dynamic Data Monitoring & Continuous Trial Support
We support the FDA’s evolving concept of continuous clinical trials by enabling near-real-time statistical oversight throughout trial conduct. This includes:
- Ongoing safety and efficacy signal monitoring
- Time-to-event toxicity evaluation
- Enrollment and trial conduct analytics
- Decision-ready dashboards for sponsors and DMCs
Dynamic monitoring enables sponsors to move from episodic, milestone-based reviews to continuous, data-driven trial oversight.
Automation-Enabled Statistical Programming
We leverage modern programming approaches to improve efficiency and quality in statistical analysis and reporting. This includes:
- R-based statistical programming in a validated, compliant environment
- Reusable analysis modules and standardized pipelines
- Automated generation of tables, listings, figures, and report-ready outputs
- Accelerated timelines from database lock to CSR
Our automation-first approach reduces manual effort while improving traceability, reproducibility, and audit readiness.
Regulatory-Focused Statistical Strategy
Our team brings deep experience supporting regulatory interactions and submissions across global agencies. We provide:
- Statistical strategy aligned with FDA and ICH guidance
- Protocol development and review
- SAP development and review
- DMC statistical support and independent analysis
- Submission-ready outputs with clear documentation and traceability
We help sponsors with sophisticated statistical approaches and regulatory strategies.
Therapeutic & Development Experience
Our statisticians support clinical development programs with focused expertise across several therapeutic areas, including:
- Oncology (solid tumors and hematologic malignancies)
- Rare diseases
- CNS and psychiatry
- Immunology and inflammatory diseases
- Non-opioid analgesics for acute and chronic pain
Our team supports sponsors from early dose-finding studies through confirmatory trials and regulatory submission.
Why Partner with us
Innovation with Discipline
Modern methods grounded in statistical rigor
Regulatory Credibility
Designs and analyses aligned with agency expectations
Efficiency at Scale
Automation and reusable frameworks
Planning-to-Submission Support
From design to submission
Our goal is simple: to help our customers improve the probability of clinical success while reducing time, cost, and uncertainty.
Let’s Connect
If you are interested in learning how our Innovative Statistics Services can support your development program, we would be happy to connect and discuss your needs.
