Contract Research Organization Services

We assist you with managing your clinical trials

Our Contract Research Organization (CRO) services ensure comprehensive and efficient management of your clinical trials.

What does CRO service consist of?

Clinical evaluation is the final validation of a medical device to confirm that it functions as intended and can be used safely by patients according to its instructions for use.

To fully comply with MDR 2017/745 and IVDR 2017/746 regulations, it is important to follow the requirements defined in ISO 20916:2019 for in vitro diagnostic devices and ISO 14155 for medical devices.

It primarily focuses on clinical research services, clinical trial data management including statistical analysis, and all necessary data to demonstrate device safety.

Manufacturers based outside the European Union planning to enter the European market must conduct clinical trials in Europe in compliance with the new MDR 2017/745 and IVDR 2017/746 regulations.

CMC has been working in the field of medical devices and IVDs for a decade; our team has over 15 years of experience; we specialize in regulatory compliance; and we can help you meet all European requirements for your clinical evaluation performance study.

We offer a wide range of professional services to assist medical device companies in launching new devices to market.

CMC can design clinical studies that comply with standards for manufacturers based on the most comprehensive regulatory guidance documents.

The current clinical guidance documents in the EU region are as follows

  • ISO 14155-2020
  • MEDDEV 2.7/4
  • MEDDEV 2.7/2 Rev 2
  • MDCG 2021-20 MDCG
  • 2021-08 MDR
  • ISO 20916:2019
  • MDCG 2021-2 – COVID-19

Representation Service

CMC can also be your european authorized representative (EC REP) for clinical trials of medical devices and/or in vitro diagnostic devices.

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Frequently asked questions about Contract Research Organization (CRO)

It is ideal to involve a CRO as early as possible in the development process, preferably during the early planning phases of the clinical study. This ensures that the study design is robust and compliant with regulatory standards from the outset.

CROs use rigorous criteria to select sites, including the site’s prior experience with clinical trials, patient availability, hospital infrastructure and the ability of the medical staff to follow study protocols.

The duration of a clinical trial can vary depending on the complexity of the device, the number of patients needed and regulatory requirements. Generally, a study can last from several months to a few years.

CROs must comply with the specific regulations of regulatory agencies, such as the FDA in the U.S., the EMA in Europe, or equivalents in other countries. These include standards on good clinical practice (GCP), data protection and patient safety.

If a medical device fails to perform as expected or causes serious adverse effects, the CRO must stop the study and conduct an investigation. This may result in modifications to the device design or adjustments to the study protocol before the trial resumes.

Why appoint CMC Medical Devices as your CRO company?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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