Clinical Development Support
Through qualified partners we offer fully integrated next steps for successful compounds
We offer a streamlined preclinical to clinical transition together with our clinical CRO partner, CR2O. Our experts collaborate with your scientific team to analyze and optimize your business-case, preclinical data packages and provide you with the relevant research projects to seamlessly transition your research from nonclinical to clinical phases. We assist you in optimizing study designs and in the planning and execution of critical studies, all while scrutinizing development costs and risks.
Our clinical partner offers a range of steps that vary in duration and clinical readiness, utilizing insights from your preclinical research results.
Gap Analysis
Impact assessment
Evaluating the disparity, often known as “needs assessment,” plays a crucial role in discerning the prerequisites for product development and gauging their fulfillment. Integral to strategic planning, this process unveils performance disparities and charts a course for bridging them.
De-risking Drug Development
An Intregrated Product Development Plan
A Product Development Plan provides clear guidance at each stage. It serves as a reality check, facilitates communication, improves alignment, drives agility and sound decision-making and increases efficiency.
Scientific and Technical Advice
Our cross functional expert team will draft the briefing booklet describing specific scientific questions and positions to seek alignment with competent authorities.
Execution
Clinical Trial Readiness
We assess this by examining the site’s patient population, resources, data collection methods, communication abilities, and experience. This phase aims to provide a strong operational plan, setting the stage for a successful trial.
Clinical Trial Execution
We provide a wide range of expertise, including Clinical Trial Management, Medical Writing, Regulatory Submissions, Data Management & Statistics, Medical Monitoring, Pharmacovigilance, and Quality Management.
治療薬開発を推進するため、専門家と提携しましょう。
Contact a development expert and let’s bring your research closer to clinical trials
医薬品開発パイプラインのナビゲーション
AAALAC認定
InnoSerはAAALAC認証を取得し、責任ある動物ケアと利用への取り組みを実証しています。AAALAC Internationalは、自主的な認証および評価プログラムを通じて科学における動物の適切な扱いを推進する非営利組織です。InnoSerのオランダおよびベルギー施設は、それぞれ2016年および2020年よりAAALAC認証を取得しています。AAALAC認証プログラムの詳細はこちらをご覧ください。
動物福祉
3R原則は、政策や規制の変更から新技術・手法の開発と普及に至るまで、あらゆる分野に影響を及ぼします。このためInnoSerは、これらのプロセスに対する継続的な取り組みと監視を実施しています。当社が実践する手順は、動物実験の代替・削減・改善を最大限に実現し、研究および医薬品開発におけるこれらの原則への取り組みを促進します。
info@innoserlaboratories.com