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.
Partner with an Expert to Advance Your Therapeutic Discovery.
Contact a development expert and let’s bring your research closer to clinical trials
Navigate The Drug Development Pipeline
AAALAC Accreditation
InnoSer has earned the AAALAC accreditation, demonstrating our commitment to responsible animal care and use. AAALAC International is a nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. Our accreditation is valid for three years, incl. 2023. Read more about the AAALAC accreditation programme here.
Animal Welfare
The 3Rs impact everything from policy and regulatory change to the development and uptake of new technologies and approaches. This is why InnoSer has ongoing commitment and monitoring of these processes. The steps we practice maximize our ability to replace, reduce and refine animal involvement and facilitate our commitment to these principles when it comes to research and drug development.
info@innoserlaboratories.com