Do what is appropriate for the stage of development of the product and for the stage of development of the company.
A day in my life at Clinipace
I am a resource to clients and the team at Clinipace Worldwide for regulatory affairs and drug and biologic development strategy.
My “a-ha!” moment
The speed at which regulatory landscape is changing. Now it’s more important than ever to have a partner with regulatory expertise to ensure that regulatory strategies and alternatives are considered at every step to help you gain product registration.
The most important consideration a client should take when undertaking a clinical research project
Compassion and a sense of urgency; a diagnosis of cancer is life altering and study subjects are equally interested in a product to prolong the quality of life.
One of the biggest misconceptions I run up against in my daily duties is
Regulatory strategy is not acquired by just reading the law, regulations and guidance documents. Keeping up to date and informed is just one part; combined with real-world experience we can ensure all relevant disciplines are involved in a clinical development project, from initial concept to regulatory strategy and submissions, quality systems implementation, clinical operations, through to the final delivery of the completed project.