For manufacturers of medicines, medical devices and DiGA as well as CROs:

We take care of the statistical part of your study, from planning to reporting

Benefit from our experience to reliably meet complex requirements. Precise and practical solutions for the successful approval of your product.
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Mastering Regulatory Complexity with Confidence

We navigate the requirements of EMA, FDA, BfArM, & Co. and ensure that your study meets all statistical specifications

Statistical expertise without internal hiring

Direct access to experienced biostatisticians, exactly when you need it

Valid study planning for reliable results

Precise and practical study designs reduce risks
Tabletten in Blistern liegen auf einem medizinischen Testergebnisblatt mit Werten für Cholesterin und Triglyceride.
Companies that trust us
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Overview of our areas of expertise

We support Pharma, MedTech, BioTech, and DiGA providers with sound statistics in all regulatory areas. From AMG, MDR, and DiGA studies to Real World Evidence analyses.

AMG Studies

Reliable statistics according to pharmaceutical law. From endpoint definition to sample size planning to complete evaluation.

DiGA-Studien

We accompany you in the planning, execution, and evaluation of your study and support the path to the BfArM DiGA directory.

MDR & Medical Devices

Statistical expertise for MDR-compliant approvals, including AI applications and complex testing procedures.

HTA & Outcomes Research

Evidence for market access and benefit assessment. Including Real World Data, Network Meta Analyses and special statistical procedures.

Register & RWE

Reliable Real World Evidence. We analyze registry and claims data for practical effectiveness and benefit assessments.

BioStats Academy

The Academy for research scientists who want to master statistics and advance their careers.

Customers report on the collaboration

Jakob Futorjanski Geschäftsführer Synaptikon GmbH
"We thank Dr. Krannich for the statistical advice and analysis, which significantly contributed to the permanent inclusion of our app "NeuroNation MED" in the DiGA directory."
Prof. Murad Alam, MD Northwestern University's Feinberg School of Medicine, Chicago, USA
“We have very much enjoyed working with Dr. Alexander Krannich from BioStats and look forward to continuing our collaboration.”
PD Dr. med. Sascha Tafelski Charité – Universitätsmedizin Berlin
"It was fascinating and inspiring to find sought-after answers from a wealth of data and to apply new methods together with Dr. Alexander Krannich."
Dr. med. Helena Stockmann Charité – Universitätsmedizin Berlin
"I thank Mr. Alexander Krannich for the nice, constructive and uncomplicated cooperation in the statistical evaluation of my data."
Dr. med. Anne‒Katrin Oligmüller St. Elisabeth-Krankenhaus Köln
"I would like to thank... Alexander Krannich for his endless patience in introducing me to the world of statistics."

About BioStats GmbH

Our services are specifically designed to combine scientific excellence with practical feasibility. With BioStats GmbH by your side, you not only receive reliable data analyses but also partner-like advice that focuses on your specific needs.

Professional statistical analysis for meaningful and robust study results

A professional statistical analysis is the key to meaningful and robust study results.
Whether it's about defining clear study endpoints, choosing an optimal study design or interpreting complex data – for us, precision, scientific integrity and practice-oriented solutions come first.
With our extensive experience in planning, conducting, and evaluating clinical studies, we provide tailored advice and support to our clients.
WE ARE MEMBERS OF:
Logos von DGPharmMed, CONELIS, WAME und International Biometric Society.
Ein Mann mit Brille und dunkelblauem Pullover steht mit verschränkten Armen vor einem unscharfen Hintergrund.
Dr. Alexander Krannich
Junge Frau mit roten Haaren, blauen Augen und einem dunklen Cardigan lächelt.
Linda Pygoch
Eine junge Frau mit braunen Haaren und einer dunklen Bluse trägt eine braune Brille.
Daniela Zurkan
Ein lächelnder asiatischer Mann in einem dunklen Sakko und einem weißen T-Shirt blickt nach vorne.
Yinan Wu

Why BioStats GmbH?

BioStats GmbH stands for scientific precision, innovative approaches, and individual solutions. Our experienced team specializes in successfully accompanying projects of all sizes. We rely on close collaboration with our clients to understand their specific questions and achieve optimal results together.

Precise Analyses

We assist with the planning, execution of your study, and help with the analysis and presentation of your data.

Individual Approaches

Whether a pilot project or a long‒term study we develop tailor‒made methods that meet your requirements.

Your reliable partner

From planning to publication, we accompany you to achieve your scientific and entrepreneurial goals.
Your Contact at BioStats
Contact us for a non-binding conversation with Dr. Alexander Krannich personally.
Frequently Asked Questions
How does BioStats GmbH support the planning of clinical studies?
We help you define clear study endpoints, select a suitable study design, and carefully plan the sample size. In this way, we ensure that your study is based on scientifically sound foundations from the very beginning.
What types of studies does BioStats GmbH have experience with?
We support a wide range of study designs, including cross-sectional studies, case-control studies, cohort studies, and randomized controlled trials (RCTs). We also have special expertise in the field of digital health applications (DiGA).
What statistical methods does BioStats GmbH use?
Our team selects the optimal statistical tests and models for your project. This also includes complex procedures such as adjustment for confounders or handling multiple tests. The goal is to achieve valid and reliable results.
What expertise does Dr. Alexander Krannich bring?
Dr. Krannich is a statistician and data scientist with many years of experience in university and industrial research. His main areas of focus include the analysis of drug studies, medical device and DiGA studies, Health Technology Assessments (HTA) and real-world data (RWD/RWE).
Ein weißes Gebäude mit roten Ziegeln und vielen Fenstern unter blauem Himmel, teilweise verdeckt von kahlen Ästen.
Our location near Berlin
info@biostats.de
Contact
info@biostats.de
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