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.
Contact a development expert and let’s bring your research closer to clinical trials
