Ensuring an Open Channel with Regulatory and Medical Policy Opinion Leaders During COVID

Many companies, particularly new entrants into the U.S. pharma arena, are facing some level of disruption or impact on their projected timelines for seeking FDA licensure, gathering data from trials for filing, conducting health economics analyses needed to demonstrate improved outcomes, or conducting real-world evidence studies that can help inform medical societies’ deliberations on clinical […]

2020 and the luxury of limitations for clinical trials

COVID-19 has had a fundamental effect on every aspect of society, including clinical trials. The search for an effective vaccine or treatment for COVID-19 continues to move at record pace. However, many clinical trials in other therapeutic areas have either been delayed or essentially ground to a halt due to the pandemic. Such delays place […]

The ‘Ripple Effect’ of the COVID-19 pandemic on clinical trials

Clinical trials are the engine room that powers our ability to deliver new treatment options to patients. The rigorous testing and resulting data that help us understand how new treatments work are what propels our industry forward.

Patient advocates: hard hit at the time of greatest need

With reduced capacity and opportunity for fundraising, extra pressure on support services and attention diverted elsewhere, it will take a long time for them to recover and return to business as usual.

Adjusting launch planning in light of clinical trial delays

Clinical trial delays not only impact the current path forward but potentially (depending on the extent of the delay/disruption) can create hurdles for future regulatory filing, approval and launch. Therefore, as with all functions being affected by the pandemic, adaptability will be critical.