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Our Services

Clinical Investigations

Whether in the pre-market or the post-market phase – a clinical investigation can be useful across all different product life cycle stages. We plan and execute the different investigation designs in accordance with the respective stage of your medical device in the clinical product life cycle: exploratory, confirmatory or observational.

Our core skills encompass the capability of providing the carefree package of all the different clinical investigation types: first in human, feasibility, pivotal, post-market observation, registry, interventional or non-interventional investigations. Included in our full-service clinical investigation package are project management, medical writing services, the statistical analysis plan and report, data management, monitoring as well as vigilance and safety. If you do not need the whole clinical investigation package, book our modular service individually. We take charge of your current situation – whether you need to obtain or maintain market access. We are your strategic partner at eye level.

Our clinical investigation procedures follow the requirements of the 2017/745 Medical Device Regulation (MDR) Articles 61-82 as well as national requirements.

Services
Clinical Investigations at a glance
Project Management
Biometrics
Safety
Monitoring
Data Management
Medical Writing
Clinical Investigation Plan (CIP)
Patient Informed Consent (PIC)
Investigator’s Brochure (IB)
Clinical Investigation Report (CIR)

Medical Writing

Our medical writing team of scientists, engineers and physicians
engineers and physicians prepare all important documents for clinical
trials – from from SOTA assessments, CEPs and CERs to CIPs, PICs and IBs.
We ensure MDR compliance and keep up to date with regulatory changes.

Services
Medical Writing at a glance
Clinical Evaluation Plan (CEP)
Clinical Development Plan (CDP)
Literature Research
Clinical Evaluation Report (CER)
Post-Market Clinical Follow-Up (PMCF) Plan and Report
Periodic Safety Update Report (PSUR)
Summary of Safety & Clinical Performance (SSCP)
Clinical Investigation Plan (CIP)
Patient Informed Consent (PIC)
Investigator’s Brochure (IB)
Clinical Investigation Report (CIR)

In vitro Diagnostics (IVD)

Regardless of the risk class of your IVD product, our experienced team of scientists, engineers and physicians takes charge of your needs. If you are in the process of obtaining CE marking for your IVD, we will identify previously collected data on your IVD for you and its clinical performance for its intended use.

Or are you looking for a post-market performance evaluation for your IVD after successful CE marking? Then we will undertake proactive data collection, analysis and reporting in order to prove the clinical performance and safety of your IVD device. In accordance with the 2017/746 In Vitro Diagnostic Regulation (IVDR), we handle your device´s scientific validity, analytical and clinical performance and safety.

Our services related to IVD products follow the requirements of the IVDR Articles 56-77.

Services
In vitro Diagnostics (IVD) at a glance
Performance Evaluation Plan (PEP)
State Of The Art (SOTA)
Performance Evaluation Report (PER)
Performance Study

Consulting

As a full-service CRO, CERES has decades of experience.
The collective in-depth consulting capabilities grant you access to this vast experience.
We are happy to advise you on the most efficient clinical and regulatory strategy you need for your medical device or IVD product.
Our focus is on your effective needs, not on our profit. Combine the profound consulting service with the subsequent services CERES has to offer and benefit from a carefree package from a single source. With CERES, you can form a strategic partnership at eye level.
Our staff of scientists, engineers and medical doctors navigate you safely through the pitfalls of obtaining product approval and accessing the EU market.
Our focus is on your effective needs, not on our profit. Combine the profound consulting service with the subsequent services CERES has to offer and benefit from a carefree package from a single source.
With CERES, you can form a strategic partnership at eye level.
Our staff of scientists, engineers and medical doctors navigate you safely through the pitfalls of obtaining product approval and accessing the EU market.

Services
Consulting at a glance
Clinical Affairs
Risk Management
Technical Documentation (TD)
Quality Management (QM)

Privacy Policy
Cookie Directive (EU)
Imprint

CERES GmbH evaluation & research

In many European countries, we have successfully conducted clinical trials and have received and updated CE approval for numerous medical devices of our clients based either on clinical investigations or on comprehensive literature evaluations.

Profile CERES
Here you can see what values CERES stands for and
who CERES is.
Career
Here you can find more information about vacancies and the advantages of CERES.
Testimonials
Read about success stories
and customer testimonials here. Find out what has convinced our customers.

Clinical Investigations
Project Management
Medical Writing
Biometrics
Safety
Monitoring
Data Management
Clinical Investigation Plan (CIP)
Clinical Investigation Report (CIR)
Investigator's Brochure (IB)
Patient Informed Consent (PIC)

Medical Writing
Clinical Development Plan (CDP)
Clinical Evaluation Plan (CEP)
Clinical Evaluation Report (CER)
Post-Market Clinical Follow-Up (PMCF) Plan and Report
Periodic Safety Update Report (PSUR)
Summary of Safety & Clinical Performance (SSCP)
Literature Research

In vitro Diagnostics (IVD)
Performance Evaluation Plan (PEP)
Performance Evaluation Report (PER)
Performance Study
State Of The Art (SOTA)

Consulting
Clinical Affairs
Technical Documentation (TD)
Risk Management
Quality Management (QM)

All service offers

Cookie Directive (EU)

Cookie-Richtlinie

Home / Cookie Directive (EU)

This Cookie Policy was last updated on 25. April 2025 and applies to citizens and legal permanent residents of the European Economic Area and Switzerland.

1. Introduction

Our website, https://www.clinical-evaluation.com (hereinafter: “the website”) uses cookies and other related technologies (for convenience all technologies are referred to as “cookies”). Cookies are also placed by third parties we have engaged. In the document below we inform you about the use of cookies on our website.

2. What are cookies?

A cookie is a small simple file that is sent along with pages of this website and stored by your browser on the hard drive of your computer or another device. The information stored therein may be returned to our servers or to the servers of the relevant third parties during a subsequent visit.

3. What are scripts?

A script is a piece of program code that is used to make our website function properly and interactively. This code is executed on our server or on your device.

4. What is a web beacon?

A web beacon (or a pixel tag) is a small, invisible piece of text or image on a website that is used to monitor traffic on a website. In order to do this, various data about you is stored using web beacons.

5. Cookies

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Some cookies ensure that certain parts of the website work properly and that your user preferences remain known. By placing functional cookies, we make it easier for you to visit our website. This way, you do not need to repeatedly enter the same information when visiting our website and, for example, the items remain in your shopping cart until you have paid. We may place these cookies without your consent.

5.2 Statistics cookies

We use statistics cookies to optimize the website experience for our users. With these statistics cookies we get insights in the usage of our website. We ask your permission to place statistics cookies.

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8. Enabling/disabling and deleting cookies

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Please note that our website may not work properly if all cookies are disabled. If you do delete the cookies in your browser, they will be placed again after your consent when you visit our website again.

9. Your rights with respect to personal data

You have the following rights with respect to your personal data:

You have the right to know why your personal data is needed, what will happen to it, and how long it will be retained for.
Right of access: You have the right to access your personal data that is known to us.
Right to rectification: you have the right to supplement, correct, have deleted or blocked your personal data whenever you wish.
If you give us your consent to process your data, you have the right to revoke that consent and to have your personal data deleted.
Right to transfer your data: you have the right to request all your personal data from the controller and transfer it in its entirety to another controller.
Right to object: you may object to the processing of your data. We comply with this, unless there are justified grounds for processing.

To exercise these rights, please contact us. Please refer to the contact details at the bottom of this Cookie Policy. If you have a complaint about how we handle your data, we would like to hear from you, but you also have the right to submit a complaint to the supervisory authority (the Data Protection Authority).

10. Contact details

For questions and/or comments about our Cookie Policy and this statement, please contact us by using the following contact details:

CERES GmbH evaluation & research
Brombacher Str. 85
79539 Lörrach

Germany
Website: https://www.clinical-evaluation.com
Email: info@ex.comclinical-evaluation.com
Phone number: +49 (0) 7621 / 167333-0

This Cookie Policy was synchronized with cookiedatabase.org on 8. April 2025.