by Prakash Achaary | Oct 24, 2023 | Blog
There are more than 2,800 CRO’s according to IBISWorld and choosing the right partner can be a difficult choice for clinical trial sponsors looking for the right data management resources. Current and upcoming pipeline projects are critical, and it’s hard to just...
by Prakash Achaary | Oct 19, 2023 | Blog
Corrective Action and Preventive Action (CAPA) is a process which investigates and solves identified issues by evaluating the causes and taking corrective action to resolve immediate issues. To be ISO 9001 and ISO14001 certified, companies must have a Corrective...
by Prakash Achaary | Oct 17, 2023 | Blog
By 2043, the cost to brings a new drug to market is estimated to be USD16 billion per compound, according to Moore’s Law. This is partly due to clinical trials becoming more complex and requiring longer follow up timeframes during studies. To mitigate the cost impact,...
by Prakash Achaary | Oct 13, 2023 | Blog
With the initial release of the Clinical Trial Information System (CTIS) in January 2022, a digital space was created for the implementation of the EU Clinical Trials Regulation (EU CTR) 536/2014, the law governing the conduct of clinical trials in the EU. A period of...
by Prakash Achaary | Oct 11, 2023 | Blog
Are you looking for rapid feedback from the FDA on a specific topic related to your product development program? Wondering which meeting request you should submit? Let’s delve into the latest updates. On September 22, 2023, the FDA released the eagerly anticipated...