Clinical investigations & evaluations

Your partner
for clinical investigations and evaluations

CERES has conducted clinical investigations in many European countries
and has obtained and maintained CE approval for numerous medical devices by comprehensively collecting and evaluating clinical data.
We guide customers through the entire process and ensure that all
regulatory requirements are met efficiently.
Sj CERES CRO Partner

Safety and performance –
our ultimate goals

Mission: CERES – the reliable CRO service provider for medical device and IVD manufacturers. We assist you with solid consulting, modular service packages and the complete clinical product lifecycle. We help you to successfully introduce your product in the European market and maintain market access.

Vision: We substantially contribute to the performance and safety of medical products and IVD and thus to the safety of patients.

Reliable results
for your medical
innovations

An international Contract Research Organisation (CRO) for medical device and IVD manufacturers, CERES offers carefree packages to customers accessing the European market.

As a full-service CRO, we take care of the complete clinical product lifecycle of your devices. We are specialised in clinical trials and evaluations for medical devices, and in IVD performance evaluations. We proactively focus on finding the most efficient solution for our customers by offering modular services combined with well-founded consulting.

Our company work ethic aims at the highest service quality and at achieving complete customer satisfaction.
CERES CRO Partner

Values that shape and
characterize our actions

We are committed to transparent and timely communication, we manage by the principles of encouragement and expectation, we have a solution-oriented attitude, we are efficient and competent. We are independent and always focus on product safety and the added value for patients.
  • Ceres Werte

    Values

    We act according to the values honesty, reliability and trust – both towards our customers and among the team.

    These principles characterise our cooperation, our thinking and our daily actions. They are the basis for sustainable partnerships and successful projects.
  • Ceres Vertrauen

    Confidence

    As in any partnership, building a trusting working relationship with customers is the basis for mutual success.

    As a dedicated service provider, we always feel equally committed to unreserved loyalty towards our customers.
  • Ceres Professionalitaet

    Professionality

    CERES employees are personally committed to the company. We act responsibly and with foresight.

    We maintain an open and honest relationship with customers and always treat everyone involved with respect and at eye level. This attitude shapes our actions every day.
  • Ceres Effizienz

    Efficiency

    Our employees’ wealth of experience guarantees a high level of efficiency in dealing with your concerns.

    We know what is necessary – and what is not – to ensure your success. Contact us and benefit from our expertise. With clear processes and well-structured strategies, we will get you to your goal faster.
  • Ceres Netzwerk

    Network

    We know the industry well and we are constantly expanding and maintaining our network of medical experts, cooperation partners and customers, thus guaranteeing long-term continuity.

    Benefit from our strong connections in the market.
  • Ceres Verantwortung

    Sustainability

    Our solutions have a long-term perspective. We take responsibility – for customers, partners, society and the environment.

    Sustainability means adhering to ethical standards, using resources efficiently and developing viable strategies. This is how we ensure continuity and reliability in a dynamic industry.

Our core team

Our solution-oriented project management style has a considerable effect
on your success. Particularly in long-term clinical trials, early consideration
of regulatory changes is important.

Our milestones

We have developed continuously since our foundation.
Our timeline shows important milestones that have shaped
our path in clinical clinical research – from the first projects
to internationalto international collaborations.
  • 2025

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  • 2021

    The MDR comes into force on May 26th.
    As your CRO for medical devices, CERES implements its services according to the latest regulations so that the needs of manufacturers can be efficiently supported during the changes and in MDR-compliant projects.

  • 2019

    We have moved to our new premises.
    On the one hand, we did justice to our steady growth. In particular, however, it was foreseeable that the upcoming MDR-related changes would require further resources.

  • 2017

    On April 5, 2017, the EU Parliament passed the new Medical Device Regulation (MDR). With a few exceptions, the regulation on medical devices is applicable from 26 May 2021, i.e. after the extended transition period.

    Manufacturers are affected by the demanding new clinical requirements and the extensive documentation and reporting requirements. Regulatory compliance forced some medical device manufacturers to take drastic steps. Thus, the transition results in a significiantly changed medical technology industry.

    Many companies addressed the challenges and realized that the changes required an enterprise-wide approach. Also, some companies recognized that MDR is not only a compliance challenge, but also an opportunity.

  • 2016

    In June 2016, the “Guidelines on Medical Devices: Clinical Evaluation, A Guide for Manufacturers and Notified Bodies”, MEDDEV 2.7/1 rev. 4, by the European Commission on Cosmetics and Medical Devices, took effect. Other relevant regulatory changes have addressed software, disposables and their re-use, implantable devices, manufacturer’s specifications, and instructions for use.

  • 2012

    Our next generation data-capturing system, “aTRIAL” was released. aTRIAL   V2 facilitates qualified electronic capture of clinical trial data, and supports handling of individual Case Report Forms (CRFs), monitoring, and reporting.

    We support the national strategy process Innovations in medical technology “Innovationen in der Medizintechnik” for medical technology and actively showed the opportunities of a proactive PMCF. The process was organized by the Federal Ministry of Economics in cooperation with the Federal Ministry of Research and Federal Ministry of Health.

  • 2010

    In 2010, the “Guidelines on Medical Devices: Clinical Evaluation, A Guide for Manufacturers and Notified Bodies,” MEDDEV 2.7/1 rev. 3, by the European Commission on Cosmetics and Medical Devices, took effect, amending Directive 2007/47/EC. These guidelines described a required periodic clinical evaluation for medical devices by either literature review demonstrating substantial equivalence to CE-approved medical devices for which adequate clinical-trial data already exist, or conducting clinical trials.

  • 2008

    In 2008, we introduced our exclusive online data-capturing system, “aTRIAL”. aTRIAL   facilitates qualified electronic capture of clinical trial data, and supports Case Report Form (CRF) handling, monitoring, and reporting. aTRIAL is an efficient EDC system, and significantly reduces the time necessary for, and cost of, data collection. Our customers can choose between collecting clinical data on paper, or via an EDC system.

  • 2007

    In 2008, we introduced our exclusive online data-capturing system, “aTRIAL”. aTRIAL facilitates qualified electronic capture of clinical trial data, and supports Case Report Form (CRF) handling, monitoring, and reporting. aTRIAL is an efficient EDC system, and significantly reduces the time necessary for, and cost of, data collection. Our customers can choose between collecting clinical data on paper, or via an EDC system.

  • 2005

    In 2005, Dr. Stephan Joeken founded CERES, foreseeing increasing requirements for clinical trials on medical devices in Europe.