The generation of data for regulatory compliance is often based on experimental work and can be complex, time consuming and costly. For example, a standard extended one generation reprotox study can cost up to £1M to complete. These studies provide much of the data presented to regulators and form the basis for regulatory approval of substances and/or products.

With so much at stake, it is important that such studies are completed to the highest standards whilst using the best technical approaches to maximise the chances of good data generation.     At CEA, our study monitoring team has many years of experience designing and overseeing experimental studies for regulatory data generation and dossier building (e.g. Physical Chemical, Toxicology, Ecotoxicology and Environmental Fate and Behaviour).

Susan Kelly, CEA’s study monitoring lead with 30 years of experience, explains the benefits of generating good data for regulatory purposes.

“To get the best data possible, it’s important to understand the guidelines and how the experimental work is done in the laboratories, where there can be issues and how to avoid them.”

Emma Russel, CEA’s principal toxicologist, also highlights the importance of study monitoring.

“There are numerous steps involved in monitoring any study, and not all are as clear-cut or definitive as they may initially appear. There are often choices to be made, with pros and cons to each one, and making the most informed one at every stage is important.”

From finding the right lab for your needs to optimising a study plan, CEA can be your expert guide every step of the way. CEA has good working relationships with a number of test laboratories, and can place big and small orders – from individual studies addressing specific endpoints or data gaps to full regulatory packages such as REACH Annexes VII or VIII.

And if the perfect execution doesn’t generate perfect results? No problem! Our experts have extensive experience critically evaluating and interpretating in vitro, in vivo, in silico and in chemico data, and can provide advice on unexpected red flags, anomalies or uncertainties along the way. This ensures that potential issues during the experimental or reporting phases are addressed at the first opportunity.

Employing an independent, informed expert for study monitoring also allows for open scientific dialogue throughout, and on interim and results prior to the final report. In addition, it reduces the potential for bias in any conclusions which may be drawn.

Finally, CEA can also advise on any result-dependent subsequent studies that might need to be undertaken within the regulatory framework you are navigating.

So whatever the need, the experts at CEA can help make sure that your study requirements are delivered to the highest standard.

Further information about CEA’s study monitoring services can be found here. To discuss your needs and requirements with one of our experts, click here.