illu CRO Main

CRO

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.

    Frau

    Ira Kurz

    Head of Data Management

    3 CRO DM

    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

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.

Sas certified advanced programmer logo

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 RStudio PBC.

R-Project logo

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

zitat

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