Contract research provider Envigo has launched an integrated service to help pharmaceutical companies navigate non-clinical safety and regulatory concerns during clinical trials.
Clinical trials
The company’s integrated solution, Pathway, optimises non-clinical safety assessment programmes to enable first-in-human clinical trials.
The platform is designed to manage the entire non-clinical safety assessment process for advanced therapies by integrating safety assessment study types and bioanalytical support. This includes scientific and regulatory consulting, programme design and project management.
Envigo hopes that pharmaceutical and biotechnology companies will be aided in navigating the increased scientific and regulatory hurdles that advanced therapies face going through safety assessment.
“Our deep expertise in the complex fields of biologics and advanced therapies adds particular value to our customers with drug development programs in these growing categories. On our customers’ behalf, we frequently work with regulators to determine the most appropriate interpretation of regulatory guidance as it applies to a specific therapeutic,” said Lee Coney, Envigo’s chief scientific officer.
“Pathway makes full use of our beginning-to-end understanding of the safety assessment process, and optimises the journey to first-in-human studies. Experience of designing and conducting studies in a wide range of therapeutic modalities, and in working with regulatory agencies around the world, means we are able to anticipate the needs of a program at design stage, plan studies accordingly, and manage an optimal timeline of study execution,” Coney added.