Learn about regulatory requirements and best practices –
concise, understandable and practical.
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.
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.
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.
-
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.
Contact us!
Customer Contact is our Focus
