Nonclinical study monitoring
A well designed and executed toxicology package can make the difference between success and failure. It is essential that these studies are designed appropriately, conducted to the highest standards, and reported with clarity, in the required timelines. An independent Study Monitor helps to select the right CRO, and ensures delivery of a quality end product that meets the needs of the project.
A Study Monitor should ideally be an experienced regulatory toxicologist with many years of expertise gained from running and monitoring GLP-compliant pre-clinical toxicology studies, at a wide range of CROs. They should have highly developed communication skills to allow open and effective dialogue between the Sponsor and CRO.
ApconiX provide the entire study placement and monitoring service. This includes selection of the CRO, advice and input into study design, oversight of the in-life phases, and reviewing draft reports for scientific and regulatory rigour.
I’ve worked with Guy Healing for the last year on CTA/IND enabling toxicology studies for 2 compounds. Guy did a fabulous job as a study monitor and toxicology consultant for the 15 studies in total placed at CROs in UK and Germany. As I am based in the US, Guy was pivotal in bridging both the time-zone difference and cultural differences with the CROs. He traveled to both CROs to conduct thorough audits of the studies and facilities providing timely and superb audit reports. Guy was also very helpful in pulling in needed expertise in other areas either via his colleagues at ApconiX or an external pathologist. Guy has great communication skills and is a real pleasure to work with. He is very knowledgeable and a great resource for toxicology advice.