Medical Writing
Clinical Evaluation Report (CER)
The clinical evaluation report (CER) is the written compilation of all available evidence on the safety and performance of a medical device and is crucial for obtaining and maintaining approval. Both the clinical data of the device in question as well as published data from equivalent devices can be included in the clinical evaluation report. Thus, equivalent products are identified in advance and gap analyses are presented. The CER addresses key points such as suitability for the intended purpose, positive benefit-risk profiles and non-inferior safety and performance objectives derived from the SOTA.
Further services
Medical Writing
Which clinical evaluation do I need for my product? Do I need a clinical study at all? What phase of the clinical product lifecycle is my device 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
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.
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.
Medical Writing
The clinical evaluation plan (CEP) outlines the strategy and methodology a manufacturer uses to demonstrate the safety and performance of a medical device. This essential document is required under MDR Article 61.
Medical Writing
The clinical development plan (CDP) is a key component of the clinical evaluation plan. It includes relevant information on past, ongoing, and planned clinical investigations of the medical device, as well as associated documents such as clinical evaluation or investigation plans, reports, or study synopses.
Clinical Investigations
Medical Writing
The clinical investigation plan serves as the foundation for the
intended clinical investigation. The CIP is written by our experts with extensive know-how in the design and execution of clinical trials. The trial planning is carried out according to the purpose and objective of the clinical investigation, from the feasibility study to approval and market surveillance. The CIP details how the product characteristics are to be validated, confirmed or identified in terms of safety, performance and risk-benefit assessment.
intended clinical investigation. The CIP is written by our experts with extensive know-how in the design and execution of clinical trials. The trial planning is carried out according to the purpose and objective of the clinical investigation, from the feasibility study to approval and market surveillance. The CIP details how the product characteristics are to be validated, confirmed or identified in terms of safety, performance and risk-benefit assessment.
Medical Writing
A post-market clinical follow-up (PMCF) report encompasses a continuous update of the clinical evaluation as outlined in the post-market clinical follow-up plan on the device in question. This plan specifies the methods and procedures to actively collect and evaluate clinical data of a CE marked device. The ultimate goal is to confirm the safety and performance of the device. The analysed data are then outlined in a post-market clinical follow-up report.
Medical Writing
The periodic safety update report (PSUR) is an observation of the benefit-risk profile over time, providing a critical assessment at defined intervals after the device’s approval. The document is a critical analysis, encompassing new safety information emerging when the device is used as intended.
Medical Writing
A post-market clinical follow-up (PMCF) report encompasses a continuous update of the clinical evaluation as outlined in the post-market clinical follow-up plan on the device in question. This plan specifies the methods and procedures to actively collect and evaluate clinical data of a CE marked device. The ultimate goal is to confirm the safety and performance of the device. The analysed data are then outlined in a post-market clinical follow-up report.
In vitro Diagnostics (IVD)
A state-of-the-art (SOTA) service goes beyond literature research. It provides insights into current treatment options for the condition the device addresses and how the new device improves treatment outcomes.
Medical Writing
We use extensive literature databases to research and identify publications that are relevant to your device. These include Embase and Medline. Search criteria to be considered may include: patient population, intervention, comparison, equivalent and similar devices and outcome.
Various databases can also be used to identify complaints as well as recalls that are related to the product, device or application in question.
The research allows evaluations to be carried out, the market situation and changes to be monitored and PMCF measures to be implemented.
Various databases can also be used to identify complaints as well as recalls that are related to the product, device or application in question.
The research allows evaluations to be carried out, the market situation and changes to be monitored and PMCF measures to be implemented.
Clinical Investigations
Medical Writing
The clinical investigation plan serves as the foundation for the intended clinical investigation. It is developed by qualified professionals with expertise in study design and execution. The plan is structured to validate or challenge the manufacturer’s claims concerning safety, performance and risk-benefit assessment.
Clinical Investigations
Medical Writing
The investigator´s brochure is based on the technical documentation and compiles all clinically and non-clinically relevant information on the medical device under investigation. It is designed to support investigators and site teams in safely managing the device while minimising risks to study participants.
Clinical Investigations
Medical Writing
The clinical investigation report (CIR) is prepared upon completion of the study. It consolidates the collected data, compares study outcomes with predefined objectives and evaluates the safety and performance of the device. The CIR is submitted to regulatory bodies and made publicly available in the appropriate databases.
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.
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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.
CER 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.