Our Consulting Services

  • Program development advise, strategy and consulting in phases I-IV

  • Strategic establishment and assessment

  • Project Management

  • Agency meeting preparation and partnering support

  • Statistical programming using SAS

  • Statistical representation and presentation to regulatory authorities (FDA, EMA)

  • Clinical trial design, simulation and monitoring system, through adaptive design and analysis using EAST

  • Expert statistical support for individual studies and programs

  • Statistical reports

  • Statistical Analysis Plans

  • Modeling and simulation

  • Nonclinical and preclinical consulting

  • Investigator Selection

  • Clinical Monitoring

  • GCP Auditing

  • Regulatory Services

  • Medical Writing

  • Data Management

  • Contract Placement

  • Nonclinical and preclinical consulting

  • Data and Safety Monitoring Board (DSMB) as chair, independent statistician, and statistical programming

  • Machine Learning

At Statogen our customer's project success is our focus. We provide expert support for Biostatistics, data management and statistical programming.

We approach our work with the goal to ensure that basic scientific discoveries translate more rapidly into new and better medical treatments.  We apply modern statistical tools and methods about the safety and effectiveness of your medical products. 

Our Recent Research Projects

 

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes

LEADER Trial Investigators

Efficacy of Plinabulin vs Pegfilgrastim for Prevention
of Chemotherapy-Induced Neutropenia in Adults
With Non–Small Cell Lung Cancer- A Phase 2 Randomized Clinical Trial

JAMA Oncology

Degludec versus Glargine in Type 2 Diabetes DEVOTE

DEVOTE Study Group

Designing and Analyzing Recurrent Event Data Trials

Stephan Ogenstad

Generalized Tests in Clinical Trials

Stephan Ogenstad

A Statistical Approach to Clinical Trial Simulations

Stephan Ogenstad

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