Are You Still Packing Your Own Parachutes?

Many independent clinical research sites forego legal counsel and negotiate their own Clinical Trial Agreements (CTAs). It will come as no surprise to hear a lawyer say that this is not a good idea, but some of the reasons may surprise you.

But the first one won’t. It’s risky. Contracts are like packing parachutes; you don’t discover the mistakes until it’s too late to fix them! The general readability of a CTA combined with the familiarity of the underlying subject can give the false impression that they are simple and intuitive. They are not. Behind those otherwise comprehensible passages is a layer of arcane, strict, and highly technical rules (like “privity of contract” or the “four corners doctrine”) that create an unforgiving “gotcha” environment that is difficult to navigate safely without legal training. Some CTAs are beautifully written and require few revisions, but many contain significant legal errors that would deeply impact the enforceability of the agreements. DIY legal work in this context is an unnecessary risk, especially when there is an affordable, efficient alternative.

But a less obvious reason why DIY legal can be problem for sites is profitability. Whether your goal is to run one site well or grow a large site network, the key is building solid processes that allow your operations run smoothly and efficiently. This requires the focused concentrations of managers and DIY legal work drains those resources. In the early days of a startup, the "all-hands-on-deck" approach - where founders and initial team members wear many hats - is not just common; it is a
necessary survival mechanism. However, as startups transition from survival to growth, this "jack-of-all-trades" model inevitably becomes a bottleneck that can stifle progress, cause burnout, and lead to failure. For a startup to scale efficiently, founders must transition from doing everything themselves to delegating responsibilities and hiring specialized experts.

Delegating the contracting phase of your trials to a legal team dedicated exclusively to that purpose is a key element of that growth.

At Boyce Life Sciences, reviewing and negotiating CTAs is what we do, and we deliver services with a unique service model. We don’t just understand the law; we understand your business and are eager to partner with our entrepreneurial clients to achieve their goals.

Contact Phillip R. Boyce, Esq. for a free consultation to explore how we could support your practice.