Standardizing clinical trial forecasting, and learning the sequence I have used ever since.
I owned the methodology but not the country organizations, so one accrual and forecasting method had to earn adoption across eight countries on quality rather than mandate. Standardize before you automate. A process automated before it is standardized just runs the wrong way faster.
Decision context
Clinical trial forecasting was fragmented. Country-level accruals were inconsistent with one another, and finance had no direct visibility into how the contract research organizations were executing.
The problem was not that anyone was doing the work badly. Several groups were each doing it reasonably, in several different ways, and nobody could reconcile the results. That is a harder problem than incompetence, because there is no one to correct.
My authority
I owned the method. I did not own the country organizations that had to adopt it, and I did not own the contracts with the research organizations. Anything I built had to be good enough that people chose it, because I could not require it.
What I built
- A single accrual and forecasting method for US-based clinical trials, documented well enough to be applied the same way by people who had not been in the room when it was designed.
- Data tracking that made execution visible to finance directly, rather than inferred from invoices after the fact.
- Internal controls, developed, implemented and validated, so the method would survive the people who built it. This is the part that gets skipped and it is the part that determines whether anything lasts.
The trade-off
Standardization costs local judgment. A country team that had built a good method for its own conditions had to give it up for one that worked acceptably everywhere. That is a real loss and pretending otherwise is how you lose the room.
What I would do differently
I would have brought the country teams into the design rather than into the rollout. I built a method and then sold it. The version where they build it with me is slower to produce and faster to adopt, and I did not understand that yet.
Standardize before you automate. A process automated before it is standardized just runs the wrong way faster, with more confidence than you had before.
Former employers and products referenced are matters of professional history. The views expressed are my own and are not made on behalf of any current or former employer, and no commercial outcome for any named product is attributed to me personally. All trademarks belong to their respective owners.
What the method still cannot see is in You Can Be Exactly Right About the Wrong Number. The ten places a patient can leave are on the philosophy page, and terms used here are defined in the glossary. The patient-side view of the same ten exits is at Where did your treatment stop?
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