Ensuring timely and accurate Regulatory submissions can be a daunting task.  The volume of processes, systems, and supporting tools needed to plan, track, author, publish, and submit to Health Authorities can be staggering. The process can be more complex when global affiliates require Rest of World (ROW) submissions.  

 Pharmaceutical companies with which we’ve worked can find it a heavy lift to complete and streamline the seemingly myriad of tasks. We’ve seen efforts encounter challenges, due to a lack of consideration and coordination among multiple, related organizations.

In this podcast RIM expert, Heather Adinolfi discusses the strategies and tactics that can effectively: 

·       Identify and anticipate common hurdles, 

·       Mitigate the impact of common unavoidable challenges, and

·       Smooth the road to success with Regulatory Information Management.

The modernization of clinical trials and the role of decentralized clinical trials are becoming an important focus in the industry. Life sciences organizations are facing a changing ecosystem. Patient access-diversity is driving the need for different types of interactions with the various stakeholders, as well as with the sponsors. It is also impacting how process, technology, interoperability, and digital maturity, are playing a role in providing patient-centric and patient-site enabled services.
www.astrixinc.com

In this podcast, we will be discussing one of the most common pitfalls in digital transformation - falling into the trap of becoming too focused on technology. As organizations seek new ways to become more efficient, they often look towards technology to solve their problems. However, when this focus becomes too narrow, and technology is allowed to drive the transformation process, organizations can miss vital opportunities for value creation and true business transformation.

Astrix’s Director of Program Management, Edwin Pagaoa, will share expert tips on how to avoid this pitfall through effective program management and focus on maximizing the business value of your transformation initiatives.