Early Development Statistics

Early Development Statistics

Right from the start

Our statisticians in the field of “Early Development Statistics“ will support you, beginning with the analysis of preclinical studies to the first in men studies (phase I) up to the important milestone – the PoC study (phase IIa). You not only benefit from our high standards of quality but also our extensive knowledge in regards to regulatory guidelines.

Preclinical Statistics

The focus is on animals

We support you in planning and evaluating your study with our longstanding experience in various laboratory and animal trials. We jointly formulate your chemical and biological processes into meaningful numbers.

We support you in every step of your study or trial. That includes the sample size estimation and its documentation in the study announcement, a detailed trial design consultancy including all statistical aspects as well as the randomization.

After completion of your study, doing a thorough evaluation is essential. It is of great significance to illustrate and interprete the results accurately.

Our expertise includes methods measuring objectives in oncology, ophthalmology, cardiovascular diseases and other therapeutic areas. In our projects we have worked with various animal models for example mice, rats, rabbits, or dogs.

Phase I/ IIa - Statistics

Humans first

With more than 10 years of experience in clinical studies of phase I/ IIa we support you in assessing pharmacokinetics, tolerance and drug safety as well as Proof of Concept Evaluation. We see ourselves not only as statistical experts, but also as contact persons assisting you while facing challenges in the study.

We accompany you through the studies from study planning to statistical analyses to publications of results in CSR, web postings or manuscripts.

Writing SAPs, calculating sample sizes, randomizing subjects, creating tables and validations are all part of our daily assignments.

In oncology trials we use all prevalent statistical methods to analyze (surrogate) endpoints. Furthermore, we offer extensive medical know-how ranging from solid tumors to hematological tumors such as leukemia and lymphomas.

In cardiovascular diseases we support you with our in-depth expertise in the following areas: heart failure, hypertension, pulmonary hypertension and thrombosis.

In the area of women’s health we are involved and have brought in our acquired knowledge in the development of contraceptives as well as medicine for endometriosis and fibroids.

The main focus of our work is the statistical analysis of your study data. In addition to descriptive statistics, we use mixed models, Bayesian methods and survival analyses to evaluate your data. Furthermore, we offer support in planning and evaluating model based dose escalation designs.

CRO overview

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Not only performance and service are just right, but above all the quality.

Please contact us, we would be delighted to give you some personal advice.