White papers
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Are you prepared for Project Optimus?
11/11/2024
Explore how Project Optimus is revolutionising oncology drug development, challenges and solutions for successful implementation in our latest whitepaper.
Whitepaper – Practical Steps to Achieve Orphan Drug Designation Status
22/06/2021
In terms of when to apply for ODD, the incentives and benefits increase for drug developers the earlier in the development process you apply. So, while you can apply any time prior to the Marketing Authorisation Application (MAA), the New Drug Application (NDA) or the Biologics Licence Application (BLA), it is more beneficial to apply […]
Effective implementation of the revised EMA First-into-Human (FiH) guidance to accelerate your early Clinical Development
17/02/2020
Dr Annelize Koch and Dr Simon Hutchings review the revised EMA FiH guidance effective February 2018, and suggest how these guidelines can be used effectively to accelerate your early clinical development.
Putting The Patient First: The Challenges and Opportunities to Improve Rare-Disease Therapy Development
10/09/2019
Advances in identifying the genetic causes of diseases, and particularly cancers, coupled with regulatory incentives to encourage the development of therapeutic approaches to once poorly managed orphan diseases have fueled a surge in exciting new medicines. However, developing such drugs requires new approaches designed to tackle some of the challenges associated with rare diseases. To […]
ICT Article UK First-in-Human and Early Clinical Trials
12/12/2018
The UK has significant experience in first-in-human (FIH) clinical trials and has performed almost a quarter of the total of 2,206 FIH studies in the EU between 2005 and 2017 (Figure 1 ). Furthermore, the number of FIH trials conducted in the UK continues to increase; 69 out of 143 (48%) Phase 1 trials in […]
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