I always believed using a contract meeting planner was going to be too expensive and just another person to manage. Having used one now for a few meetings recently, I was wrong. The cost is easily covered by my ability to focus on far more critical tasks that align with my everyday role, the logistical execution was FAR better and smoother, and most importantly, all my attention could be on the meeting itself. 

The question I often get when putting together a clinical strategy is where and when IITs make sense within a given program. The answer to that question is not normally straightforward, as it depends on several factors, including but not limited to the phase of development the therapy is in, whether the IIT goal aligns with the organization’s goals, and the intended use of the data after the study.

Recently I have helped several smaller organizations review and select their CRO. Choosing the right Clinical Research Organization (CRO) is a critical decision that can significantly impact the success of your clinical trial. Particularly for a smaller company, finding the right solution – both with regards to capability and culture – is critical.

In recent months, unexpected changers and leadership shakeups at the U.S. Food and Drug Administration (FDA) have sent ripples through the biotech investment community. The FDA’s decisions directly influence the timelines, valuations, and viability of emerging biotech companies. When leadership becomes unstable or politically influenced, investors start re-evaluating risk—and that’s exactly what’s happening now.

“Resourcing a clinical trial is one of the most critical things to get right. The protocol can be 'perfect', the sites top performing, and subject selection appropriate. However, if you don't have a solid clinical team…then all that effort up front may still lead to data that is not evaluable and/or regulatory compliant.