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Premier Research’s dedicated medical device group offers an unparalleled source of strategic and tactical input to the medical device, combination products, and biologics industry through expertise and innovation. From complete strategic planning of clinical trials, monitoring, Ethics Committee/Competent Authority submissions, CE mark certification, FDA clearance support, and medical writing, to handling special needs on extremely short notice, Premier Research can meet all of your clinical needs. Our multi-lingual clinical research associates are located in more than 30 countries and are among the most qualified and experienced professionals within the medical device industry.
Premier Research services for medical devices are based on an active certified quality system according to ISO 9001 and ISO 13485. All monitors are trained according to the same internal training system by a dedicated CRA trainer. Our quality system corresponds both to the ISO 14155 GCP guidelines applicable in the European Union and 21CFR part 812, 50 and 56 applicable GCP rules in the United States as well as additional national laws and regulations applicable to the conduct of clinical investigations.
Our CRAs are highly trained professionals with strong medical and clinical backgrounds including extensive hospital and clinical practice experience. The combination of vast therapeutic knowledge, medical experience, and continuous training in new technologies enables us to focus on quality and efficiency in any area. For more information on our experience, click here.
For more information on our Medial Device group and service offerings, please contact us.
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