December 13, 2017 | Débora Araujo of Boehringer Ingelheim is featured on this podcast from Cambridge Health Tech Institute for the SCOPE Summit for Clinical Ops Executives, which runs February 12-15, 2018 in Orlando Florida. Araujo discusses her expertise in clinical trial agreements and some of the daily challenges she faces in negotiations and contracts. She specifically discusses some of the key barriers within and beyond the legal language of CTAs and also shares highlights from her forthcoming book, The Four Villains of Clinical Trial Agreement Delays and How to Defeat Them. Here is a sample of the discussion that takes place. Podcast

CHI: You're speaking at SCOPE Summit 2018 specifically around streamlining CTA negotiations beyond the legal language. What are some of the barriers within and beyond the legal language you've faced and how did you work them out?

Débora Araujo: Within the legal language, I would say that's perhaps one of the biggest barriers that we have within CTA negotiations currently… One of the major barriers within the legal language, I'll say, is really being able to get a consensus between all the parties involved, particularly the sponsor and the site, [to] be able to get a consensus on the must-haves and the nice-to-have sort of situations. So the areas that we really see a lot of challenges are the bigger areas of the CTA, which is publication, indemnification, intellectual property, subject injury, and confidentiality. Those are sort of the big ones that, within CTA, we really see a lot of barriers.

It really stems from each organization, each sponsor and site; they have a certain level of risk they want to take within those areas. They have certain things they want covered. But at the end of the day, it's really being able to reach a nice compromise and a consensus in that. There's a lot of things that can be done actually within the legal language and being able to speed things up. Just one of them is just being able to have both parties sit and look at what are their must-haves I mentioned, and what are their nice-to-haves? What are areas they can be more flexible and allow for that flexibility within the negotiations really, and really assessing the level of risk they're willing to take and just being able to reassess that and reassess that constantly because the industry is very fluid, so it's being able to get that consensus.