Consulting
Clinical Affairs
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.
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.
Clinical trials in every phase
Reliable from
development to
market support.
Whether in the pre-market or post-market phase – a clinical trial can be useful in all different phases of the product life cycle.
We plan and conduct the various study designs according to the respective phase of your medical device in the clinical product life cycle: exploratory, confirmatory or observational. We ensure that each study design is precisely tailored to your objectives and regulatory requirements.
requirements.
Our core competencies include the ability to provide an all-round carefree package for all types of clinical trials: First-in-human, feasibility, pivotal, post-market observational, registry, interventional or non-interventional trials.
From planning to implementation and evaluation, we take we take care of all steps and ensure smooth implementation. Thanks to our comprehensive expertise and strong network, we guarantee the highest quality and regulatory safety.
Further Services
Consulting
Which clinical study do I need for my product? Or do I need a clinical study at all?
What phase of the clinical life cycle is my product in? How extensive do the clinical data to
be collected need to be? You will find answers to these and other questions in this section.
What phase of the clinical life cycle is my product in? How extensive do the clinical data to
be collected need to be? You will find answers to these and other questions in this section.
Overview
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.
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.
Consulting
A technical documentation (TD) is a prerequisite for the conformity assessment and approval of medical devices. In consulting, manufacturers are guided in establishing comprehensive technical documentation and ensuring all necessary components are covered.
Consulting
Manufacturers receive assistance in setting up and implementing risk management plans, including identifying risk analysis and the intended purpose of the device. A thorough risk assessment is integral to the process.
Consulting
The implementation of a QM system is a fundamental requirement for medical device manufacturers. We support manufacturers in optimizing and developing an efficient QM solution that complies with international standards; in particular ISO 13485. Our QM service helps to identify requirements and suggests necessary adjustments.
Full-Service-CRO
Your advantage with CERES
Benefit from our interdisciplinary team of medical writers. As a full-service CRO, we focus
on medical devices, IVD and other medical technology solutions. We offer the compilation of modular, individual documents but as a qualified partner, we also take over your entire project. From consulting, to planning and writing to project management.
on medical devices, IVD and other medical technology solutions. We offer the compilation of modular, individual documents but as a qualified partner, we also take over your entire project. From consulting, to planning and writing to project management.
-
Tailored Services
You choose with the help of our consulting services – is a tailored modular service ideal for you? Or do you prefer to book a package, intro or large?
It is your decision – just ask us. -
Transparent Costs
Whatever you decide you need – our modular services or the carefree package – you will receive a detailed offer with transparent and comprehensible costs. No hidden fees. -
Plan your ROI
Our expertise helps you to reach your aims sooner, more efficiently and more economically: to market introduction and a projectable and secure ROI. -
The Best Team for your Success
Our colleagues are experts in medicine, the sciences, biostatistics and engineering. This interdisciplinary team
takes you safely to your goal. -
Experience and Know-How
We combine decades-long experience with focused know-how – we are your partner at eye level! You can rely on
us – with us, you cannot go wrong.
We look forward to meeting you! -
A very strong
NetworkFor over 20 years, we have been working in this field – we are familiar with everyone involved! Rely on our strong network and benefit from a well-established CRO.
Clinical Affairs Request
With care
and expertise –
for your study.
You have developed an innovative medical device
and now want to conquer the market?
We support you in the most important core processes.
We make sure that all interfaces are defined and
considered. With us, you will always be up to date.
and now want to conquer the market?
We support you in the most important core processes.
We make sure that all interfaces are defined and
considered. With us, you will always be up to date.
Service Packages
From planning to approval –
everything is included.
Instead of individual services, our customized packages offer an end-to-end solution – from planning to approval. from planning to approval. With structured project management, clear processes and a reliable dual-control principle, we ensure efficiency, quality and regulatory compliance in every phase of your clinical trial.
Large
With the most comprehensive package of CERES services,
you acquire the carefree package. Not only do we plan a clinical trial (both for market approvals and PMCF), we also carry out the trial, from biometrics and safety to communication with the authorities.
This is our core skill and our USP: thanks to our excellent network and our knowledgeable staff, multicenter, international clinical trials are what we do best. Our USP thanks to our
excellent network.
you acquire the carefree package. Not only do we plan a clinical trial (both for market approvals and PMCF), we also carry out the trial, from biometrics and safety to communication with the authorities.
This is our core skill and our USP: thanks to our excellent network and our knowledgeable staff, multicenter, international clinical trials are what we do best. Our USP thanks to our
excellent network.
Medium
The medium-sized package is aimed at manufacturers of
medical and/or IVD products who wish to make targeted use
of services to prepare for a clinical trial.
In contrast with the large package, however, we do not conduct studies within the medium-sized package, but provide you with comprehensive support in planning, strategy and the necessary preparations.
medical and/or IVD products who wish to make targeted use
of services to prepare for a clinical trial.
In contrast with the large package, however, we do not conduct studies within the medium-sized package, but provide you with comprehensive support in planning, strategy and the necessary preparations.
Small
The small package is our basic package for manufacturers
of medical and/or IVD products. With the literature analysis (SOTA), we pave the way for a successful clinical or performance evaluation, for which we prepare both the plan and the report.
On request, we can supplement the package with a comprehensive literature search that brings together relevant scientific data and findings.
of medical and/or IVD products. With the literature analysis (SOTA), we pave the way for a successful clinical or performance evaluation, for which we prepare both the plan and the report.
On request, we can supplement the package with a comprehensive literature search that brings together relevant scientific data and findings.
Intro
You are not quite sure what your next steps are, or whether
you need to collect clinical data? Whether you are a start-up,
an SME or a corporation, book our intro Package – we will provide clarity.
With our intro package, you receive our in-depth consulting, combined with a literature search, so you can make informed decisions based on a solid data foundation.
you need to collect clinical data? Whether you are a start-up,
an SME or a corporation, book our intro Package – we will provide clarity.
With our intro package, you receive our in-depth consulting, combined with a literature search, so you can make informed decisions based on a solid data foundation.