September 25, 2023
Usually, activities in clinical trials are conducted in clinical trial sites that are experienced or well-versed in clinical trials. In fully decentralized clinical trials (DCTs), all activities occur at locations other than traditional trial sites, such as at the homes of trial participants or in local healthcare facilities that are convenient for trial participants
September 18, 2023
A robust Quality Management System (QMS) is an important aspect of a Pharmaceutical company as it demonstrates a company’s Senior Management commitment to Quality. QMS instills the mindset that assures that the company will have qualified and trained individuals who focus on “Quality” throughout the lifecycle of the product.
September 7, 2023
The drug safety environment is heavily regulated and continuously evolving, with numerous compliance challenges. Since the start of the COVID-19 pandemic, many pharmacovigilance monitoring activities have taken place remotely. Insights gleaned from these reports can help companies remain compliant when conducting pharmacovigilance during COVID-19 and beyond.
August 26, 2023
In any pharmaceutical development program, there are risk-benefit analyses being done to assist with decision-making processes. Expedited development presents a different balance to a company’s risk-benefit in order to bring a particular molecule forward as quickly as possible because of the potential benefits.
August 18, 2023
The drug safety environment is heavily regulated and continuously evolving, with numerous compliance challenges. Since the start of the COVID-19 pandemic, many pharmacovigilance monitoring activities have taken place remotely. Insights gleaned from these reports can help companies remain compliant when conducting pharmacovigilance during COVID-19 and beyond.
July 26, 2023
Biologics are complex molecular entities that require extensive planning and development strategies to control development costs, ensure compliance with regulations, and speed up a product to commercialization. Hiring a biologics consultant ensures you receive expert advice and support throughout the entire CMC development process. In this article, we will outline why you should consider a biologics consulting service and what benefits this will have for your company.
