An aging global population, combined with continued unmet needs in ocular diseases that carry genuine quality of life implications, has created a boon of interest and opportunity in developing new eye disease treatments. 眼科の治験は極めて特殊であり、患者さんや介護者の経験に関する詳細な知識、質の高い研究機関との深い関係に加えて、眼科イメージングに関する技術的スキルや様々な治療手段が必要とされます。
There remains a finite number of clinical research sites in a competitive clinical landscape. You need a CRO with deep and long-standing site relationships, a comprehensive global view of an evolving treatment and clinical research landscape, and disease-specific expertise in developing drugs, biologics, devices and specialty products for eye disease.
サイネオス・ヘルスは、新しい眼科治療法をリードするグローバル治験のプロバイダーです。
過去5年間に15件のAMD試験と9件の緑内障試験、また様々な適応症での多数の試験を実施し、弊社は眼球の前方部、後方部ともに眼科領域の治験で世界をリードするCROです。
450人を超える薬剤開発の専門家と医師による弊社のチームは、最先端の眼科治療薬の上市や、あらゆるモダリティにおける実験的治療の発展に寄与しています。
- 眼内、全身および皮下への注射
- 局所点眼薬および軟膏
- 内服薬
- 外科的介入
- 医療機器
- コンビネーション製品
特殊母集団を含む、あらゆるタイプの被験者募集に関する専門知識
- 小児科
- 高齢者
- 希少疾病
世界中の治験責任医師との長期かつ継続的関係
Through this experience, we have developed long-lasting relationships with investigators around the world. Our historical data allows identification of top performers for nearly every disease in all global regions.
また、弊社は、眼科治験で実施医療機関と日々協働し、その臨床環境を正確に把握しているため、新規の治験プログラムを実施する場合も、施設選定、開始時期や方法について、的確なアドバイスをすることができます。
We collaborate with some of the leading providers of specialty technical services to support your trials. Our partner reading centers provide training and certification for all modalities, including OCT, angiography, fundus photography, ERG and more.
BCVA認証のトッププロバイダーとグローバル提携し、市販品を対照薬として利用する場合は、世界中のどこであっても、それを必要とする場所に配送する方法を把握しています。
What does all this experience mean for your ophthalmology development program? Here are just a few examples:
- 最初の被験者の組入れ（試験のマイルストーンとして）
- We customize a targeted start up plan by selecting the right site in the right location. Our accelerated model allows us to use pre-qualified ophthalmology sites, expedited document collection, grandfathered certifications and a Trusted Process® partner IRB to get your study off the ground, recruiting weeks ahead of the industry standard.
- お客様の候補薬剤の臨床開発および商品化に関するアドバイス
- Our team is deeply entrenched in current and upcoming care standards and clinical programs. We routinely prepare clinical development plans, aid in regulators’ preparations and write protocols to bring success in a competitive marketplace.
- アーリーフェーズから国際共同治験まで、サービス規模を拡大
- We have the country knowledge and site relationships to scale with your growing needs. We have developed long-lasting relationships with ophthalmology investigators at nearly 600 sites around the world - many of which are members of our exclusive Ophthalmology Catalyst Site Network. We know where ophthalmology sites are and how they have performed, and will provide a fit-for-purpose strategy based on real data.
- 未治療又は希少疾病の被験者募集
- We have proven recruitment and retention strategies to engage with patients and their caregivers. Participating in research in ophthalmology is a big commitment, and we understand how to find and support patients with work, family and other life circumstances to manage. Through study branding, traditional and social media channels, referral practices, text messaging, smartphone and web applications, and patient concierge services, our internal team of patient recruitment and retention experts is part of the planning for every study, from the start. We believe that recruitment planning cannot be part of a mitigation strategy months into a study. And we know that patients and investigators have many care options, so careful consideration for how to reach and motivate is critical for enrollment success.
