Medium Package

Preparing Clinical Trials in a Targeted Manner

The medium-sized package is aimed at manufacturers of medical devices and/or IVDs who wish to take advantage of selected services that are an optimal preparation for a clinical investigation or a performance study.
Paket Mittel CERES CRO Partner

The Perfect Preparation and Supplement for Your Investigation

In the medium-sized package, we take over selected tasks such as project management, medical writing, biometry, safety, monitoring or data management.

Typically, the individual tasks can be described as follows: the identification and selection of appropriate sites and partners as well as project coordination; the compilation of all relevant documents for the application and approval of the ethics committee and the competent authorities; a robust sample size calculation and justification for your planned study according to the a state-of-the-art and the planning and implementation of a sound statistical analysis; a comprehensive and reliable safety management reflected in a safety manual, in which we cover both the handling of adverse events and incident reports; the complete monitoring services with a detailed monitoring plan from the initiation visit to the close-out monitoring visit; a reliable data management; from the creation of case report forms (CRFs) in accordance with the investigation plan, the selection and implementation in the EDC system, to data of the highest quality.

Further Packages


Service Paket Intro

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.
Service Paket Medium

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.
Service Paket Gross

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.

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.
  • Kostenstruktur

    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.
  • Markteinfuehrung

    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.
  • Frueher Roi

    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.
  • Bedarfsorientierter Ressourceneinsatz

    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.
  • Expertise Schnittstelle

    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!
  • Ceres Vorteile

    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.

We Give our Best

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.
Service EN

FAQs Packages

Do you still have any questions? Take a look at our FAQs.

Yes, our focus on the most efficient solution for you and your product.

Our services cover a broad range – from in-depth consulting to multi-year, multicenter, international clinical studies. You can find an overview of our packages here.

We are ISO 13485 certified and cover both MDR 2017/745 and IVDR 2017/746. Nothing stands in the way of an application to the ethics committee and market approval.
Our services primarily address the EU market, but we also provide services for overseas markets. Just ask us!

While the intro package is completed within a few days, the large, most comprehensive package can take several years.
Do you have a specific question? Ask us, give us a few key points and we will estimate the scope for you.

You can find more details in the package overview and a brief description. Are you still unsure? Contact us.