Clinical Operations

Introduction

The transition between preclinical and clinical is so important – to company value, operations, resource requirements, and perception, that many small companies will describe themselves proudly as “clinical stage”. It is indeed a signal that they possess the wherewithal to succeed preclinically, and are now proceeding into human trials, where good decisions are quite literally life-and-death.

What

The team, funding, and organization needed to succeed preclinically is not the same as what is needed in the clinic. Whether managing trials internally or (more commonly) managing a CRO who manages your trials, more MDs, more money, and more organizational bureaucracy are all needed to succeed in this high-stakes stage. While it is possible to be a purely “virtual” clinical drug developer, and it is possible to run trials almost entirely with your own employees, it is far more typical to blend the strengths of your internal team (augmented for the clinic) with CROs.

When

Approximately a year before entering the clinic, your team should be actively building clinical operations. While a single CMO might have sufficed to plan your Phase I trial, once in the clinic, a real organization will be required.

Why

Approximately 90% of all drugs that enter the clinic fail. While some were doomed from the outset, some fail due to less-than-ideal clinical execution. Trial costs can reach into the hundreds of millions and span a decade, and patients are relying on savvy clinical operational judgements. There can be no compromise here.

Learning Goals

Goals, roles, costs, and operational structures for clinical operations.