Choosing the right non-clinical CRO

Non-clinical contract research organisations (CROs) are an integral part of modern drug development. For any novel agent, delivery of GLP toxicity data to support clinical trials is a crucial step that requires a professional organisation with dedicated management, infrastructure and a broad array of technical and scientific skills.

In selecting a CRO, the sponsor typically looks at capability, timelines and cost. However, other factors such as geography, communication and the quality of the interpretation and final report can also play a vital part in the successful delivery of a project.

Independent study monitors with broad knowledge of this area can provide an effective solution to navigating this complex landscape and give a valuable third-party perspective to the benefit of both the sponsor and CRO.

The partnership between CROs, pharma and independent experts plays a key role in driving improvements in our industry and ensures we deliver appropriate data to regulators, and better value to the sponsors.

Dr Richard Knight and Dr Guy Healing discuss how to make a better decision in PharmaTimes.

Read more here: Choosing the right non-clinical CRO

 

 

 

 

By |2018-09-12T14:07:14+00:00September 19th, 2018|Toxicology, Press|Comments Off on Choosing the right non-clinical CRO

About the Author:

Dr Richard Knight PhD, ERT, is a Director and Co-founder of ApconiX, a preclinical toxicology and ion channel company that brings together a team of world-renowned nonclinical safety experts. Richard graduated from the University of Bradford in 1989 with a degree in Biomedical Sciences (Pharmacology) before gaining a PhD at the University of Leeds researching the role of adenosine receptors in renal function and toxicity. His research then included post-doctoral studies at University of California, Los Angeles (UCLA) into the effects of ischaemia/reperfusion injury on cardiac metabolism. Richard joined Zeneca Pharmaceuticals, Safety of Medicines Group in 1996 as a Study Director, and then Project Toxicologist across multiple therapy areas, from early discovery through to market. As Lead Toxicologist for Oncology, Richard was a member of both the Drug Safety and Metabolism, and Oncology Leadership teams with responsibility for safety across the AZ oncology portfolio. In this senior role he provided leadership and mentoring support to other project toxicologists. Richard has worked on many drug platforms over this time including small molecules, biologics, proteins and oligonucleotides and has been involved in bringing over 30 new candidate drugs into clinical trials and 5 to marketing approval.