Aligning Your Clinical Operating Model – a Case Study by CSL Behring

CONTENT IN COLLABORATION WITH CSL BEHRING
Valerie Reynaert, Head of Global Clinical Operations, CSL Behring

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“What clinical operating model do you use?” This question was the basis of a discussion between Halloran Consulting Group and CSL Behring which led to collaboration during a recent Halloran-hosted Clinical Operations Breakfast virtual event on the topic “Transitioning to a Different Clinical Trial Operating Model: An Insider’s Look.”

CSL Behring’s presentation centered around identifying four different operating models – all in-house, hybrid, integrated Functional Service Provider (FSP), and fully outsourced – and how to right size the right model for different clinical trial settings. Choosing an operating model requires analysis of multiple factors including company size, number of programs, priorities and values, and geographic reach, and each selection is unique.

The choice of model is deeply important, as there is a tradeoff between cost, speed, and quality. But can you have it all? Well, there is no one model that reduces the cost of every operational component, and where speed and quality are never comprised to achieve a trial’s outcome.

But there are certainly successful examples. While FSPs are an important part of the clinical ecosystem, CSL Behring shared how they transitioned from a fully outsourced to a full in-house model for a critical role in the clinical trial management realm, and the steps they took along the way to achieve more control and ensure quality processes during the lifecycle of their trials.

In this article, we will explore the operating models, dive into the benefits of an all-in-house or targeted, yet integrated FSP operating model, and discuss how best to approach the transition.

A Model is a Model

Operating a clinical trial, regardless of the development phase, is reliant upon clinical operations professionals to complete essential tasks throughout the entire lifecycle of the trial. Smaller companies may not have the resources in-house or the pipeline to justify an integrated FSP model, and therefore utilize independent contractors to handle an array of traditional and non-traditional services in concert with their full-service Clinical Research Organization (CRO). Larger companies often have the budget and pipeline to support an all-in-house model and/or a selectively targeted FSP model.

Sponsor companies are compelled to establish an all-in-house or fully outsourced model appropriate for their goals, pipeline, and budget. The default, often by convenience or necessity, tends to be an outsourced model to full-service CROs which may or may not progress to the preferred provider or sole source arrangements. An integrated FSP model is one step removed from an all-in-house model, adding a layer of consistency and continuity, but still requires synchronization between roles and responsibilities for Full Time Employees (FTEs), FSPs, and any additional outsourced components.

Regardless of the operating model, transitioning to a different model takes time, energy, and commitment. If a transition is to be made, those at the company must determine their driving factors, and rationale, and enable those conversations forward because upfront planning is essential to success.

Finding Motivation and Transitioning to an All-In-House Operating Model

When sponsor companies evaluate their operating model, they are acknowledging there are issues in control, performance, timeliness, and/or quality throughout the clinical trial stages.              

In the case of CSL Behring, they needed to establish and maintain strong clinical trial site partnerships – a component of their clinical operations ecosystem they intended to improve. Under their prior model, sites had multiple touchpoints with many different professionals at CSL Behring and with their CRO. CSL Behring reflected upon what was working, identified headwinds, and solicited feedback from their sites to improve the relationships.

The site dynamic and relationship needed to be enhanced. CSL Behring understood the critical value of treating sites as key stakeholders in the clinical research ecosystem and began to plan a different approach. Their solution was to create a Clinical Site Ambassador role, partnering with a vendor to provide these resources through an FSP. Resources fulfilling this role would later assume all interactions with their managed sites as a single point of contact.

CSL Behring sought to achieve:

• A direct line of communication between CSL Behring and their sites
• Consistent and streamlined communication across all studies
• Increased performance, quality, and visibility into study activities and challenges
• Overall improvement in site satisfaction

As a result, CSL Behring was able to observe measurable improvements in quality, dependability, and speed across their studies. Additionally, their relationship with their sites drastically improved over time because of the timely and consistent communication and follow-through.

Operating Model Success

When sponsor companies approach their operating model transition, it is important to ensure that each step is thorough and aligns with a quality mindset. Recommendations include:

• Clearly identify the existing challenges to overcome
• Hold honest feedback sessions with vendors, sites, and internal personnel
• Define the vision, direction, necessary infrastructure, and metrics to assess the success
• Obtain internal stakeholder buy-in for the proposed transformation
• Establish a process to forecast and scale (or retract) resources based on the pipeline demands
• Evaluate studies that would most benefit from this approach, and rollout through direct communication with teams
• Take lessons learned from initial rollouts and implement them in future studies
• Partner with an industry leader who can provide objective best practices and recommendations as needed

About Halloran Consulting Group’s Clinical Services

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About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. CSL Behring’s portfolio of innovative medicines includes a wide range of recombinant and plasma-derived products for treating bleeding disorders, immune deficiencies, and chronic inflammatory demyelinating polyneuropathy, as well as hereditary angioedema and Alpha 1 Antitrypsin Deficiency.

Learn more about CSL Behring.