Clinical Investigations
Safety
Safety refers to the reporting of any (serious) adverse events with a
causal relationship with the device under investigation and/or any device
deficiencies that could potentially have led to an (serious) adverse event had no appropriate action been taken. In addition, the handling of medical device complaints is also included.
causal relationship with the device under investigation and/or any device
deficiencies that could potentially have led to an (serious) adverse event had no appropriate action been taken. In addition, the handling of medical device complaints is also included.
Further services
Clinical Investigations
Which clinical study 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? Do I need a clinical events committee? 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 product lifecycle is my device in? Do I need a clinical events committee? 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
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.
Our clinical investigation procedures follow the requirements of the 2017/745 Medical Device Regulation (MDR) Articles 61-82 as well as national requirements.
Clinical Investigations
Good project management ensures seamless coordination between the sponsor, investigation site, principal investigator (PI), monitor, ethics committee (EC), competent authority (CA) and medical writers. Our project management ensures that all critical decisions and documents are thoroughly reviewed and guarantees that quality and timelines are reliably met.
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.
Our clinical investigation procedures follow the requirements of the 2017/745 Medical Device Regulation (MDR) Articles 61-82 as well as national requirements.
Clinical Investigations
The biostatistician supports clinical investigations by determining the
appropriate sample size, developing statistical analysis plans (SAPs) and conducting data analyses upon study completion. The resulting statistical analysis report (SAR) ensures data integrity and compliance with regulatory requirements. Whether for regulatory submissions or scientific publications, biometricians tailor statistical methodologies to align with study endpoints and hypotheses, providing robust and reliable results.
appropriate sample size, developing statistical analysis plans (SAPs) and conducting data analyses upon study completion. The resulting statistical analysis report (SAR) ensures data integrity and compliance with regulatory requirements. Whether for regulatory submissions or scientific publications, biometricians tailor statistical methodologies to align with study endpoints and hypotheses, providing robust and reliable results.
Clinical Investigations
Monitoring is the means to oversee the progress of a clinical investigation and to ensure its accordance with the clinical investigation plan. This guarantees that the conduction, recording and reporting are uniform, plausible and correct and that the investigational site files are kept up to date. Monitors verify the source data and ensure the recruitment and patient informed consent procedures are followed appropriately. The monitors, clinical research associates (CRAs), are the first point of contact for the investigational sites. Monitoring supports both sites and data management in clarifying any questions that may arise.
Clinical Investigations
Data management is responsible for reliable date, recording and processing of data as part of a clinical investigations. For this purpose, case report forms (CRFs) are created in accordance with the protocol. The quality of your data is ensured by reviewing and clarifying open questions. In addition, data management maintains and archives the associated databases and manages the various user accesses for investigators, monitors, etc.
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.
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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.
Safety 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.