CERES Service
Medical Writing
Our medical writing team of scientists, engineers and physicians engineers and physicians prepare all important documents for clinical investigations and evaluations – from from CEPs, SOTAs, and CERs to CIPs, PICs and IBs.
We ensure MDR compliance and keep up to date with regulatory changes.
We ensure MDR compliance and keep up to date with regulatory changes.
Reliability from R&D
to Market Surveillance
Our medical writing team is composed of scientists, engineers and physicians who specialise in the preparation of essential documents required for clinical investigation applications to ethics committees and competent authorities.
Among many others, these documents include comprehensive literature research leading to a state-of-the-art (SOTA) document, a clinical evaluation plan (CEP) and clinical evaluation report (CER). In the case of a clinical investigation planned and executed for your medical device, the services provided by medical writing extend to the clinical investigation plan (CIP), the patient informed consent
(PIC), the investigator´s brochure (IB), and the clinical investigation report (CIR).
In addition, the case report form (CRF) is compiled by our experts. Moreover, our medical writers compile all documents for Orphan Medical Devices as well as Legacy Devices and handle Well-Established Technologies (WET).
All medical writing documents follow the requirements of the 2017/745 Medical Device Regulation (MDR) Articles 61-82. With every change of regulation, we have our finger on the pulse of time.
Services included
Medical Writing
CERES has extensive experience with medical devices in the areas of regulatory, quality and clinical affairs. Class III to I devices, implants and active implants are the subject of our work. We prepare your clinical evaluation report (CER), your CEP, PMCF, SSCP, PSUR, CIP, PIC, IB and much more.
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.
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.
Medical Writing
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 approval. The CER identifies equivalent devices and outlines a gap analysis. It 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.
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.
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.
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.
In vitro Diagnostics (IVD)
To plan, continuously conduct, and document a performance evaluation,
the manufacturer must establish a performance evaluation plan (PEP).
The PEP defines the performance evaluation process and outlines key
parameters, taking into account the intended purpose and use of the IVD, the specification of the analyte to be determined, the target patient groups, clear indications, possible contraindications, and limitations. Additionally, the PEP should detail the intended methods and statistical tools used to evaluate the analytical and, if applicable, clinical performance of the IVD.
the manufacturer must establish a performance evaluation plan (PEP).
The PEP defines the performance evaluation process and outlines key
parameters, taking into account the intended purpose and use of the IVD, the specification of the analyte to be determined, the target patient groups, clear indications, possible contraindications, and limitations. Additionally, the PEP should detail the intended methods and statistical tools used to evaluate the analytical and, if applicable, clinical performance of the IVD.
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.
In vitro Diagnostics (IVD)
The performance evaluation report (PER) combines all elements of clinical evidence and constitutes the key document for the IVD´s performance evaluation. As far as beeing applicable, it should include the scientific validity report, analytical performance report, and clinical performance report, along with an assessment of these reports to demonstrate clinical evidence, including a justification for the chosen approaches. The PER is continuously updated – annually for Class C and D IVDs, and as needed for Class A and B IVDs, based on new clinical data, post-market surveillance findings, or significant changes in the SOTA.
Full-Service CRO
The CERES Advantage
Take full advantage of our interdisciplinary medical writing team. As a full-service CRO with a focus on medical devices and medical technology solutions, we are at your disposal as a qualified contact for both specific documents and entire projects. From project management and creation of plans to writing of sound reports.
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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.
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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!
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A Very Strong Network
For 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.
Medical Writing Request
With Care and Expertise –
for Your Project
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.
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 Small to Large –
Always Exactly what You Need
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.