Centaur Clinical Speciality Clinical Operations Solutions for Medical Devices

Centaur Clinical is a clinical research organisation (CRO) specialising in operational solutions for Class I, Class II and Class III medical devices.

The company supports medical device manufacturers working in a wide range of therapeutic areas to undertake clinical trials that meet the regulatory requirements of the EU and the US. These include recognised standards such as ISO14155, CFR21-part II and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) good clinical practice (GCP).

Centaur Clinical has formed strong partnerships with a number of CROs worldwide to meet clients’ requirements. Its services include regulatory affairs, market access and clinical affairs strategies, as well as reimbursement procedures and the creation of medical writing.

CRO services for the development of medical device clinical study protocols

Centaur Clinical provides cost-efficient CRO services for medical device manufacturers throughout the product’s lifecycle. The firm is experienced with devices in various application such as oncology, cardiology, orthopaedics, gynaecology, dermatology, cardiology and neurology.

The company introduces clients to experts from its wide network of industry professionals, which offer advice and guidance on medical device concepts and prototypes. This supports the writing of clinical study protocols and clinical research project development.

Centaur Clinical’s biostatisticians also provide a biostatistical method of analysis for the clinical trial protocol, which help to determine the number of volunteers required to achieve a statistically significant result.

Medical device EU regulatory submission preparation

Centaur Clinical has a thorough understanding of regulatory practices in the EU and helps prepare manufacturers for inspections and audits.

The company supports the CE marking process by developing clinical and regulatory affairs strategies.

Management of documentation for medical device registration and auditing

Centaur Clinical provides documentation for medical device regulatory submissions and audits, including investigator brochures (IB), clinical trial protocols, case report forms (CRF), informed consent forms (ICF) documents, instructions for use (IFU), patient diaries, clinical study reports and clinical evaluation reports.

The company also provides health economics and reimbursement processes.

About Centaur Clinical

Currently working with companies in the EU and the US, France-based Centaur Clinical aims to extend its services to North Africa and countries bordering the Mediterranean Sea. The company is also developing relationships with CROs worldwide to improve the quality of its processes.

To provide better support for its clients, Centaur Clinical also develops new electronic tools for database management and electronic trial master files (TMF) and contributes to the field of immuno-oncology and small biotech activities for drug projects.

 

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Centaur Clinical

29 avenue d’Aix,

13120 Gardanne

France

+33 9 67 08 56 76 +33 4 42 59 56 76 centaurclinical.com

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Centaur Clinical

29 avenue d’Aix,

13120 Gardanne

France

+33 9 67 08 56 76 +33 4 42 59 56 76 centaurclinical.com

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