Raul had just been designated Global Process Owner for informed consent (ICF).  Because Raul was known as a competent leader with a deep internal network, his nomination, politically speaking, was non-controversial.  However, before Raul could start to put his skills as a competent leader to work, he had to get his head above water.  Metaphorically speaking, he was drowning in work.

Raul was thrust into an organization where dozens of stakeholders depended on ICF, they all had question/problems/confusion daily, and they all thought (for various reasons) they should be at the top of the priority list for Raul.  Who can blame them?  They’re just trying to keep trials moving along in a safe and compliant manner.

Unfortunately, Raul was expected to answer these questions, but he was new to the role.  He did not have pinpoint detailed specific knowledge of his process at the local context level (e.g., country/site).  That body of knowledge took years for his predecessor to develop, but stakeholders aren’t interested in your ramp up time, they want their problem solved.  Raul needed to figure something out.

Meanwhile, the stakeholders’ requests kept coming;  The entire organization depended on, and expected Raul, as the GPO for ICF, to be able to answer all questions, from the most detailed to the most strategic, as well as be ‘in position’ should an investigator have questions or findings.

How did we get here?

It’s not the stakeholders’ fault, nor is it Raul’s fault, nor was it his predecessors’ fault.  The role was never architected for throughput, it was architected for control.  However, there is a tension between throughput and control:  Most high control organizations are low throughput organizations (i.e., the team that comes together for annual budgeting cycles.  High control, low throughput).  On the other hand, think about grocery store checkout lines:  If you wanted to, you could slip a pack of gum into your pocket and walk right out.  Mischievous young people do it all the time.  Low control, high throughput.

When PharmaCo, Raul’s employer, developed the GPO role, it was following sound logic:  We need a single point of accountability for regulated processes despite our global footprint.  This is an intentional design decision that automatically answers the question, “Where do we send the regulators when there is a problem.”  Over time, this role morphed into a ‘be all end-all’ with a single person at the center, but enough work for 5-10 FTEs on any given day.  In other words, the position has become overloaded.  We needed a new model that could keep up with stakeholders needs (i.e., regulators, study managers, patients, and other internal employees)

The primary issue:  Centralized control without the necessary bandwidth creates bottlenecks in complex organizations

A central point of control becomes a bottleneck when the point of control cant keep pace with the inputs, which, in most large organizations, is all the damn time.  This is why it can take 2 months to get an agenda item onto the calendar of a steering committee.  A perfect example of this:  Check your inbox.  How many unread emails do you have right now?  Imagine if each one of these emails represented a mission critical issue in your portfolio of trials.  How far do you go back and address these issues?  A week?  A month?  A year?  Point being, you are the centralized point of control for your email box, just as the GPO is the central point of control for the global process.  Their email looks 10X worse than yours, and 80% of their emails are from people who need support on global processes.

How Raul activated the community for better communication and coordination

Raul needed to maintain primary responsibility while enlisting the ‘community’ to be more responsive to the needs of sites, investigators, and most importantly, patients.  Here’s what he did.

First, Raul found other subject matter experts on ICF and officially assembled them into a community.  He then communicated the primary issue in non-ambiguous terms (“We are putting studies at risk because we cant respond quickly enough to questions and clarifications about ICF”).

Next, he aligned every one on the goal (primary intent), parameters (bright red lines), and principles (directional guidance) of the ICF process.  This ensured everyone had similar grounding.

The community, for the next 4 weeks, and for 1 week every quarter thereafter, activated a communication campaign.  They explained to the broader stakeholder community what the problem was the community was trying to solve (“We are putting studies at risk because we cant respond quickly enough to questions and clarifications about ICF”).  They then talked about how they wanted to experiment with new ways of working around this issue to better coordinate how they worked together.

Raul and the community aligned on a single inbox all questions related to ICF.  This brought transparency to the volume of requests and allowed the community to help process the requests.  They also set up a Kanban board to visualize flow of questions and improve transparency on response times.

Through a new lens:  A network creates multiple interlocked channels of information flow

Raul found a way to activate a network to get more done with more people while maintaining accountability on his process.  The key take-away here is this:  As a regulated industry attempting to accelerate timelines while keeping patients safe, we have to move beyond the simple models of accountability.  If we want to harness the most brainpower and creativity from our teams, we have to be willing to experiment with different operating models.  This is how we can improve operations while staying safe and compliant.

Until next time,

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