Preclinical Drug Discovery & Development | CRO Selection
Generating a robust, focused, and convincing preclinical data package is fundamental both in drug discovery and development. Failure to appropriately plan and execute a suitable preclinical development program is a common source of regulatory application failures and delays.
ToxHub provides unique preclinical consulting services in order to help our clients in their drug discovery and development strategy. This service helps to reduce time and cost, and ensures the successful launch of new products. We offer over 25+ years of experience in developing drugs targeting inflammation and pain, CNS diseases, anti-infectives, and MDs, cosmetics and food supplements.
For each consulting request, we provide a customized and personalized service with:
- A complete and topic-related literature search,
- A thorough analysis of available data on the drug or therapeutic target,
- Our interpretation and recommendations for a successful drug development.
Some examples of drug development support are as follows:
– implementation of specific preclinical models
– high-throughput biomarker screens
– Mechanism of Action models
Preclinical Strategy: We help you to define and describe your preclinical development plan as well as your preclinical safety and efficacy endpoints to optimally support your regulatory and clinical strategies.
Study design and oversight, for example:
De novo preclinical package design: We work with you to understand your intended clinical population and setting and carefully develop a preclinical package in a relevant model with meaningful safety and efficacy endpoints.
Oversight of preclinical study execution: our in-house expertise can be deployed (remotely or in person, as necessary) to oversee the execution of preclinical studies and analyze the generated data.
Preclinical data compilation and review: We compile data from your lab and study reports. We evaluate this data using statistical analysis software to help you to understand your preclinical data and its trends.
Preclinical package gap analysis and study design: We review your existing preclinical data package and carefully develop a comprehensive preclinical roadmap to make your data package more robust and complete.
The preclinical consulting services include a continuous interaction between ToxHub and our clients with phone conferences, on-site face-to-face meetings, and a complete consulting report including scientific references.
Moreover our consultants have extensive experience with setting up new biomedical research laboratories. Our streamlined processes include preliminary meetings and/or site visits to identify client needs, laboratory planning, vendor recommendations.
If you are looking to outsource your work, ToxHub will form a devise and detailed project plan, and mediate the negotiations with CROs to perform your study.
We have well-established relationships with CROs, manufacturers and vendors both in Europe and in extra european Countries, guaranteeing seamless implementation and significant time- and cost-savings for our clients.