Founded in 2013, Cogitars provides advanced biostatistical consulting and technology solutions for small and mid-sized biotech and pharmaceutical companies, supporting drug development from preclinical research through all clinical phases (Phase I–IV) and HTA.

With more than a decade of international experience, Cogitars has become a trusted partner for biotech companies worldwide. Our services combine innovative statistical methodology, adaptive trial design, and modern data science approaches to support efficient and regulatory-compliant clinical development.

While Cogitars supports multiple therapeutic areas, our core expertise lies in Oncology, where innovative trial designs and complex statistical methods play a critical role in accelerating development and improving decision-making.

Our team of 20 statisticians and statistical programmers across Europe (Germany, Italy, the UK) combines deep expertise in Bayesian statistics, adaptive trial methodology, AI/ML applications, and programming in R, SAS, and Python. By integrating traditional statistical approaches with advanced modeling and predictive analytics, we enable faster, more informed development decisions while maintaining the highest regulatory standards.

Services Across the Development Lifecycle

Preclinical Development

Cogitars supports early-stage programs by providing rigorous statistical planning and analysis.

• Preclinical study design
• Sample size and power calculations (including animal studies)
• Statistical analysis and reporting of preclinical studies

Bioinformatics
• Biomarker discovery and validation
• NGS data analysis
• Gene and protein expression analysis

Phase I / Phase II Development

Early-phase trials benefit greatly from innovative adaptive designs and real-time data monitoring.

• Bayesian adaptive trial designs
• Dose-escalation studies (BOIN and BLRM) using CogitarsSuite
• Dose optimization in line with FDA Project Optimus
• Real-time trial monitoring via cogiviz
• Full statistical programming and reporting (CDISC-compliant datasets and regulatory-ready submissions)

Phase II / Phase III Development

Cogitars supports pivotal studies with robust statistical methodology and predictive analytics.

• Clinical development planning and statistical strategy
• Phase II/III (pivotal) trial design
• Sample size and power calculations
• Prediction of timepoints for interim and final analysis using cogipredict
• Statistical analysis for pivotal trials
• Regulatory submission support

Technology Solutions

Cogitars combines consulting expertise with proprietary technology solutions designed specifically for modern clinical trials.

CogitarsSuite:
Platform for Phase I dose-escalation trials with simulation-based design according to the latest FDA guidance on Bayesian methods.

cogiviz:
Real-time monitoring and visualization of clinical trial data, including live tables, listings, and figures (TLFs) from first patient in (FPI) onward.

cogidata:
Automated creation of CDISC-compliant datasets for efficient, submission-ready reporting.

cogipredict:
Predictive analytics platform for interim and final analysis forecasting, supporting better trial planning and faster development decisions.