Medical device and diagnostics research is a broad and increasingly complex area. Our experienced and specialized team ensures that studies on your products generate evidence to help them gain approval. We have a dedicated business group focusing solely in this area whose knowledge can guide you from concept to market.
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20+
経営陣の平均経験年数
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400+
医療機器／体外診断用医薬品の試験実績
医療機器／体外診断用医薬品に関するユニークな規制情勢
In the process of bringing products from concept to market, there are requirements that are unique to medical device and diagnostics. Unlike drug development, your product is an “invention” that can be refined if there is evidence to support design modifications. We have performed more than 400 studies in this area, with emphasis on user feedback, to optimize your product.
経験豊富なサイネオス・ヘルスが、お客様の医療機器／体外診断用医薬品の試験を成功へと導きます。
サイネオス・ヘルスのチームは、心臓／血管、美容、整形外科、IVD、および汎用機器／手術等、広範な領域にわたる臨床試験を、アジア太平洋地域、ヨーロッパ、および米国でサポートし、成功に導いてきました。弊社チームは、臨床試験の微妙な特異性やニーズをつぶさに捉えて、試験デザイン、規制上の手続き、実施医療機関の管理、および試験実施の課題についてのソリューションを提供します。
Everyone on the team is CFR, GCP and ISO-14155 trained to ensure your program is compliant anywhere in the world. We also have the experience to know how best to budget and operationalize your study, whatever the phase. We understand the requirements and different needs of an FIM/feasibility, pivotal or post-market study.
薬事規制
サイネオス・ヘルスには、Predicate device（合法的に市販されている機器）の評価や提出資料を含む510(k)、Pre-IDE会議、PMA準備および提出を含む IDE準備、CEマークならびに医療機器／体外診断用医薬品のクラス分類決定での実績があります。
試験に関する専門知識
Our expertise includes the following types of study: Combination device-drug delivery products; Health economics and Reimbursement; FIM and Feasibility; Human factor; IVD and Companion Diagnostics; Post-approval and specialized statistical models; and combination products.
サイネオス・ヘルスは実施医療機関および治験責任医師と協働し、お客様の製品で最適なアウトカムを獲得します。
サイネオス・ヘルスは、2017年のCenterWatchのGlobal Investigative Site Relationship Surveyで、グローバルCRO 10社の中から「Top CRO to Work With（一緒に働きたいCRO）」に選ばれました。
These accolades reflect our dedication and ability to collaborate effectively with global customers and sites in the development of new treatments to improve patient lives. Many of our CRAs and Project Managers are dedicated to specific sites and investigators, and have worked closely with them for over a decade, so they know the most suitable sites and investigators to achieve the best outcomes for your product.
サイネオス・ヘルスは、自社開発のTrusted Process®を用いて、お客様の医療機器／体外診断用医薬品試験の品質を確保します。
Our Trusted Process is flexible and scalable to adapt to any sized company or study. It is the project management methodology we use that is proven to deliver dependable outcomes and actionable results, both on time and on budget. We have the knowledge and strategies required to successfully develop your medical device.
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