You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
In the clinical research industry many rely on a regulatory strategy, or a regulatory plan. Having a strong foundation to build upon for a research team is vital for success. When regulations are the building blocks the goal of compliance can be more readily achieved- and in the end, keep patients safe. This is the main objective of our industry; how can it be realized?
Topics: Regulatory Strategy, Regulatory Intelligence, Tim Felgate
An article in MD+DI dissects the difference between a regulatory strategy and a regulatory plan by simply asking five questions to regulatory affairs expert, Michael Santalucia. We found this article to be very interesting, considering many may not have examined these differences before, which may lead to better regulatory understanding and success. The five questions, and summarized comments from the article, are listed below:
Topics: Regulatory Strategy, Michael Santalucia, FDA, MD+DI