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CONTRACT RESEARCH ORGANIZATION

Planning and analysis of studies in all phases of clinical development.

We support the planning and analysis of clinical trials in the pharmaceutical industry and investigator-initiated studies. We offer in-depth statistical expertise with relevant software experience in statistics, programming, data science, data management, and medical writing.

We bring our services to the following areas of drug and medical device research and development:

Preclinical development
Pharmacokinetic and pharmacodynamic studies (Phase I)
Proof-of-concept and dose-finding studies (Phase II)
Market approvals based on pivotal studies (Phase III)
Observational studies and non-interventional studies (phase IV)
Additional benefit assessment in the context of the AMNOG procedure

In addition, we are also active in related areas, such as registries, marketing studies, diagnostics, publication support, and exploratory analyses.

Data Management
Innovative data management as the foundation of your study
Chrestos offers data management services based on state-of-the-art software and online technology. Depending on your needs, we can take over the complete data management or only selected tasks.
Whether a regional, monocentric, multicenter clinical, non-interventional, or medical device study, our experienced and flexible team will implement the project according to the client's needs.
In doing so, we adhere to the customer's or our internal SOPs and work in accordance with current standards and regulatory guidelines.
Ira Kurz
Head of Data Management
Highest quality: from data collection to analysis
The quality of data collection and data preparation is crucial for the validity of studies.
At Chrestos, we favor web-based platforms that make it quick and easy to collect high-quality clinical data. In addition, an optimal design enables faster and better data validation so that statistical analysis can be performed without delay.
All study participants can be networked within a secure system and have access to the modular study components according to their roles.
Valuable time can be saved thanks to digital, reusable, and automated workflows.
Our services
- CRF Design
- eCRF implementation
- User training and support
- Creation of data management and validation plans
- Programming of plausibility and consistency checks
- Discrepancy and query management (data cleaning)
- Integration and validation of external data (e.g., lab, app data)
- ePRO / eDiary
- Reconciliation of adverse events
- Medical coding (MedDRA, WHO-Drug)
- Study-specific status reports
- Electronic data transfers
- CDISC STDM data sets
Programming
Programming at Chrestos means cross-disciplinary collaboration with data management and statistics. At Chrestos, we place a great deal of emphasis on technical expertise in related disciplines to ensure efficient and adequate data processing in the clinical trial process.
Our range of topics is so diverse that we have formed focal points.
From left to right:
Dr. Jessica Hirsch: Head of Programming
Dr. Daniel B. Ciupka: Head of Multi Data Analytics
Vitali Gering: Head of Oncology
Jessica Högg: Head of Late Development Analytics
Our services
- TLF Programming
- TLF Specification
- Validation
- CDISC standards: ADaM-/SDTM structure
- Pooled analyses
Multi Data Analytics
In the Multi Data Analytics team, we support the creation and analysis of complex data with different data models (ADaM, SDTM, SDTM+). Our focus is on the transformation of extensive data across studies. To ensure the quality of the data, we not only visualize based on the data sets, but also continuously during the transformation process.
Oncology
Cancer poses immense challenges to our society today. There is an urgent need to explore a versatile and broad spectrum of therapeutic options, particularly due to the heterogeneity of tumors. Our Oncology Programming team has many years of experience in analyzing oncology studies, and taking into account response criteria such as RECIST.
Late Development Analytics
In the area of later clinical development, we support the evaluation of Phase II, III, and IV studies. We create tables, graphs, lists, and data sets for statistical reports, regulatory submission documents, journal publications, and conference proceedings. For time-critical ad hoc analyses, we deliver fast and reliable results. In addition, we have many years of experience in cross-study evaluations in integrated analysis.
Early Development Statistics
Preclinical Statistics - Focus on the Animal

Preclinical Statistics covers the early non-clinical phases of drug development. We support our scientific partners in both: basic research and preclinical studies. We also work with marketed medicines, for example in toxicology and safety pharmacology or when investigating new mechanisms of action. These studies are mainly animal-based and in vitro.

We use a wide range of descriptive, exploratory and inferential methods. Our services include, in particular, experimental design, sample size calculation, randomization, data evaluation, visualization, interpretation of results, general statistical advice, report writing and assistance with regulatory affairs and scientific publications.

Nina Besche
Head of Early Development Statistics

Phase I/ IIa – Statistics - Focus on the Human Being

In Phase I/ IIa clinical trials, we provide support in the evaluation of pharmacokinetics, tolerability, and safety of the drug, as well as in the proof of concept evaluation.

We accompany the studies, from the planning and preparation of statistical evaluations to the publication of the results.

Our daily tasks include the development of a statistical analysis plan, case number calculations, randomization of study participants, and the preparation and validation of tables.

The core of our work is the statistical analysis of the study data. For the analyses, we use descriptive methods as well as mixed models, Bayesian methods, and survival analyses. We also offer support in the planning and implementation of model-based dose escalation designs.
Our Services

Sample size calculation

Randomization

Study evaluation

Pharmacokinetics

Proof of concept

Bayesian analyses

Dose escalation designs
Late Development Statistics
Our team accompanies clinical studies from dose finding to approval and beyond. In addition to investigating the efficacy of a drug, we also focus on examining the safety and providing support in evaluating the benefit-risk ratio.

We take over the organization and planning of the statistical aspects of a study or advise on specific statistical questions.

Continuous training, a lot of enthusiasm, and passion characterize our work. We deliver accurate and robust results in compliance with current guidelines.

Alexander Pieper
Head of Late Development Statistics

We have extensive experience in the indications of ophthalmology, cardiology, nephrology, and infectious diseases. In addition, we have developed a wide range of statistical expertise, especially in time-to-event, responder analyses, Bayesian methods, and (network) meta-analyses.
Our services:

Planning of the study design

Preparation of the study protocol

Planning of sample size

Preparation of SAPs and TLF specifications

Programming of statistical analyses in SAS and R

Interpretation of statistical analyses

Preparation of statistical reports

Implementation of study-related committees, e.g., Data Monitoring Committee, Steering Committee

Inquiries during the approval process at various authorities (FDA, EMA, BfArM)

Publications for journals and conferences

Advice on the approval of DIGAs (digital health applications for the german market)

Statistical evaluation of DIGAs
Biometrics & Diagnostics
Real World Evidence
Real data, concrete results
Real World Evidence (RWE) demonstrates potential benefits or possible risks of medicines based on Real World Data (RWD) generated in clinical practice outside traditional trials.
We clarify the safety, efficacy, and cost-effectiveness of drugs and medical devices. In this way, we help develop better therapies and prove their value.
Diagnostics
Personalized health care - The next generation of healthcare
Early and accurate diagnosis is integral to decision-making along a patient's entire health or disease trajectory. Medical treatments are increasingly tailored to the unique needs of individuals or smaller groups of patients.
We assist in the further development and control of in vitro diagnostics and the evaluation of laboratory measurements.
Chrestos Institute
Statistical service for researchers and scientists
Biometris & Diagnostics' mission is to improve the quality of data-based research.
We contribute our extensive experience in the fields of biometrics and diagnostics. In addition, we accompany every phase of scientific projects, from planning to evaluation and publication.
Frieder Wolff
Head of Biometrics & Diagnostics
Our strengths
- Propensity Score Matching
- Indirect comparisons / meta-analyses
- Non-interventional studies / registries
- Markdown and Shiny
Our services
- Statistical consulting
- Study design (design/number of cases)
- Study analysis
- Publication support
- Interactive reports
- Validation / quality control
Health Technology Assessment
The last vital step to improving patient healthcare: the systematic and evidence-based evaluation of new medical procedures and technologies.

For the requirements in the field of HTA, we rely on the combination of statistical methodological expertise and programming experience.

Our HTA team consists of statisticians with broad prior experience in the various phases of clinical development. All team members are certified and experienced in SAS programming and also use the advantages of R for specific scenarios.

Dr. Sabrina Siebert
Head of Health Technology Assessment
Focus on benefit assessment in Germany

We offer statistical expertise to demonstrate additional benefit
Statistical consulting

We assume the role of the HTA statistician in the dossier team. We take care of all statistical aspects within the benefit assessment, including:

Consultation meetings

Strategy development

Analysis planning

Review of the analyses

Interpretation of the analyses

Dossier preparation

Written statement

Oral hearing

We are familiar with the methodological requirements of the G-BA and IQWiG as well as the possibilities and challenges of the implementation.

Statistical analyses

We perform the necessary additional analyses of clinical studies in accordance with the requirements of the G-BA and IQWiG. Our priority is quality; however, we are also aware of the requirement for efficient and rapid analyses. To meet both needs, we generally validate our analyses by double programming.

Our services at a glance:

Subgroup analyses

Additional / sensitivity analyses

Competing risk / propensity score

Visualizations

Meta-analyses

Indirect comparisons
Medical Writing
Medical documents for drug and medical device development must not only be formulated precisely and scientifically, they must also meet formal international requirements.

We aim to present the complex data and scientific relationships in an understandable and informative manner.

We support you with our expertise and experience in the preparation of all required documents during drug and medical device development.

Collaborating with Chrestos Data Management and Biostatistics provides a fast and direct interdepartmental communication.

Ira Kurz
Medical Writing
Unsere Leistungen

Preparation of study protocols (phase I-IV, NIS/PASS, Medical device)

Preparation of clinical study reports (phase I-IV, NIS/PASS, Medical device)

Creation and maintenance of Investigator's Brochures

Preparation of Safety (Update) Reports (DSUR, PSUR)

Posting study Results

Support in the preparation of regulatory documents

Support in the preparation of GB-A applications

Support in publication (journals, congress contributions, posters)
Biomarker Statistics & Data Science
Biomarker Analyses
Biomarkers are becoming increasingly important in clinical research and drug development. They serve as a tool for diagnosing a disease, monitoring the course or the success of the therapy, as a surrogate endpoint of a clinical trial, or as a basis for developing personalized therapies. In addition to classic clinical parameters (laboratory, ECG, etc.), measured values are also generated with the aid of modern technologies; for example, to analyze genetic information or physical activity.
The resulting, often large and high-dimensional data sets, and the processing of individual and explorative questions are the challenges in biomarker statistics. Our experienced team from biostatistics and data science provides support from planning the analysis, programming, and evaluation to the interdisciplinary communication and scientific publication of the results.
Data Science
Beyond the field of biomarkers, we support the processing, exploratory analysis, and visualization of data of any type, drawing on our diverse experience in classical statistics and machine-learning methods.
If recurring tasks are involved, we offer the possibility of a generalized solution. We develop individual and professional tools such as pipelines for documented and reproducible data analysis with automated reporting or web apps for interactive data visualization and presentation. We provide these tools in the form of R packages, taking advantage of the diverse capabilities of R Markdown and Shiny, among others.
Services and expertise
- Exploratory Analyses of Biomarkers
  
  Laboratory, omics, digital
  
  Broad spectrum of statistical methods incl. machine learning
- Tool development
  
  Custom R packages for reproducible and robust in-house analyses
  
  Automated reports and interactive web apps using R Markdown / Quarto and Shiny
- Trainings
  
  Shiny, R Markdown / Quarto, tidyverse, git
Dr. Sebastian Voß
Head of Biomarker Statistics & Data Science
Medical Affairs
Communication is our strength

In the area of Medical Affairs, our analyses help to better understand the drug in order to provide relevant information to medical doctors and patients. We answer medical questions that are of interest to various functions in the healthcare system. How well does the drug work compared to other therapies? In which patient subgroups do side effects occur frequently? What is the impact of the treatment on quality of life? Could the drug be used for other indications?

We help our clients generate new knowledge and expand existing knowledge. The comprehensive communication and presentation of data is the key to making medical content accessible to medical professionals and patients on an interdisciplinary basis. This way treatment strategies for patients can be continuously optimized - this is dear to us.

Chrestos Canada Corp.

Our Medical Affairs team consisting of employees from statistics and programming is internationally based. We support our customers from our headquarters in Essen as well as from our subsidiary Chrestos Canada Corporation in Toronto.

Ricarda Norenberg
Head of Medical Affairs
Our services

Statistical consulting in the area of Medical Affairs

Support in planning and preparation of publications according to GPP3 Guideline

Communication with the publication team and key opinion leaders

Creation of graphical representations for congress posters and presentations

Study planning & analysis of post-marketing studies

Programming of tables and figures

Tools - Our quality promise

SAS Institute Inc.

As a rule, SAS® is set as the industry standard for analyzing clinical studies. All employees in the areas of programming and statistics have completed the certification program of the SAS Institute.

The R Project for Statistical Computing

We also use R in the pharmaceutical environment for dynamic and innovative solutions. All employees can program with R. Our team includes a trainer certified by Posit Software, PBC (formerly known as RStudio, PBC).

More flexibility with Chrestos Temporary Work.

Tempwork illu engl

We offer well-trained temporary staffing professionals within the permit-required employee leasing framework. For more than ten years, Chrestos has held a permit for temporary staffing in accordance with the provisions of the AÜG.

All employees receive permanent employment contracts and are covered by social insurance. Our offer of assignments within the framework of temporary employment, has created an additional possibility for our customers to support them via this channel as well. We know the skills and strengths of our employees, most of whom have been with our company for years. Therefore, we can select the right people for the occasion.

What opportunities does Chrestos Temporary Work offer?

If your regular staff needs support through project-specific experience or if your staff situation is insufficient due to temporary absences, we offer you the opportunity to deploy our employees temporarily. For the duration of the assignment, you as the hirer have full authority to issue instructions. However, there is no obligation to continue to pay wages in the event of illness, or provide paid vacation. Our hourly rates take into account the ancillary wage costs for our employees.

Flexibility

React flexibly and at short notice to internal changes or fluctuations in the market

Efficiency

Targeted deployment of our experts according to your needs

Security

The best possible security. You only pay for the productive working time

Our partner

Flexopharm logo

Flexopharm GmbH & Co. KG

Industriestraße 40, 44628 Herne

Tel. +49 (0)2323 – 957 970

https://www.flexopharm.com/

We offer the following services through our partner FLEXOPHARM®:

Quality Assurance

Development of quality assurance plans
Performance of audits
Execution of reviews

IMP Handling

Import of investigational medicinal products from non-EU countries
Blinding and labeling of investigational medicinal products
Transport to the trial sites
Preparation of emergency envelopes

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CONTRACT RESEARCH ORGANIZATION

Planning and analysis of studies in all phases of clinical development.

OUR AREAS OF EXPERTISE

Data Management

Innovative data management as the foundation of your study

Ira Kurz

Highest quality: from data collection to analysis

Our services

Programming

Our services

Multi Data Analytics

Oncology

Late Development Analytics

Early Development Statistics

Preclinical Statistics - Focus on the Animal

Nina Besche

Phase I/ IIa – Statistics - Focus on the Human Being

Our Services

Late Development Statistics

Alexander Pieper

Our services:

Biometrics & Diagnostics

Real World Evidence

Real data, concrete results

Diagnostics

Personalized health care - The next generation of healthcare

Chrestos Institute

Statistical service for researchers and scientists

Frieder Wolff

Our strengths

Our services

Health Technology Assessment

Dr. Sabrina Siebert

Focus on benefit assessment in Germany

Statistical consulting

Statistical analyses

Medical Writing

Ira Kurz

Unsere Leistungen

Biomarker Statistics & Data Science

Biomarker Analyses

Data Science

Services and expertise

Dr. Sebastian Voß

Medical Affairs

Communication is our strength

Chrestos Canada Corp.

Ricarda Norenberg

Our services

Tools - Our quality promise

More flexibility with Chrestos Temporary Work.

Our partner

Through diligence, clarity, and flexibility, we achieve the best possible results.