Simply handing off multi-million-dollar studies to CROs without carefully crafted plans for communications and reporting operational data as the study unfolds is hardly a wise move, yet what kind of oversight is needed?
Reforecasting clinical trials based on the latest data and information can improve operations and overall trial performance and is a critical component of keeping your company’s plans in line with its financial position and on track to meet its goals.
Finding and getting access to clinical trials can be challenging if not daunting for patients. For those who don’t qualify for a study, but still want to gain access to the medicine, there are a few newer options: compassionate use and right to try.
The focus on technology as a driver of performance improvement in clinical trials is intense, but despite years of valiant efforts, study execution remains far from optimal. For study startup, the data are dismal.
What exactly do terms like remote, site-less, hybrid, and decentralized trials mean and do for us? In order to work together, we need to better understand each other and what terms help and hinder our progress.
Sponsors primarily outsource to CROs to control operational and infrastructure costs. Although there are obvious benefits to outsourcing, it creates new challenges around quality, oversight, collaboration, and governance.