We provide statistical support for small and medium Biotech and Pharma companies. from preclinical research through all clinical phases (Phase I–IV) to HTA. Our services can be engaged at any stage, ensuring flexible and reliable support whenever it is needed. Since our establishment in 2013, we have gained over a decade of in-depth experience and have grown into a trusted partner for numerous international clients. Being experts in Oncology studies, we also provide service in other therapeutic areas like Immunology or Diabetes. With our expertise, we ensure the highest standards of statistical accuracy, precision, and compliance, contributing to the success of development programs worldwide. 

We offer expertise in the following areas:

• Biostatistical Strategic Consulting: Providing tailored statistical guidance to optimize clinical trial design, execution and outcomes. Includes CRO Oversight.

• Adaptive Trial Designs using Bayesian Statistics: Designing and implementing innovative, flexible trial structures that allow for modifications based on interim data. 

• Dose Escalation/Optimisation:  Support dose finding and dose optimization using approaches such as BLRM (Bayesian Logistic Regression Model) or BOIN (Bayesian Optimal Interval Design). We also provide model-based dose evaluation in line with FDA’s Project Optimus, integrating PK, PD, efficacy, and safety data to identify patient-centered dosing.

• Interim Analysis Prediction App: With our innovative app cogipredict, your interims and final analysis can be predicted. 
• Real-Time Data Monitoring: You get the full overview on your study data in real time as we customize our visualization platform cogiviz to your study.
• Comprehensive Trial Reporting: Delivering detailed and robust programming to support regulatory submissions and ensure compliance with global standards using our programming tool cogidata.

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