June 2022 | Vincent Puglia

We would like to welcome back Vincent Puglia, Director, Clinical Supply Systems at Regeneron, as he continues with part 2 of “The Fit and the Pendulum.” To provide a balanced view on the keys to provider/partner success, Vincent interviewed and hosted a roundtable discussion with two experts in vendor management: Jay Lind, Director, Vendor Strategy & Relationships, Clinical Development Operations at AbbVie and Mark Gianelos, Associate Director, Vendor & Relationship Management, Global Development at Regeneron. Thank you, Vincent, for sharing with us insights from that discussion.

Onboarding And Maintaining eClinical Systems and Technology in Clinical Trials: The Right Fit is Key to Provider/Partner Success

Shifting Focus: Provider/Partner Success

Now that we have given some thought in the first part of the series on methods for better defining the sponsor needs, requirements, and necessary outcomes, let’s turn our eyes towards setting providers and partners up for success.

To identify the proper fit and have a broader perspective on calibrating the structures around the critical sponsor and partner relationships, I held a roundtable discussion with two experts in the realm of vendor management: Jay Lind, Director, Vendor Strategy & Relationships, Clinical Development Operations at AbbVie and Mark Gianelos, Associate Director, Vendor & Relationship Management, Global Development at Regeneron. Both have decades of experience in both the provider and sponsor domains and are subject matter experts who I  gratefully rely upon on as brilliant resources and advisors.

Right Fit Means Right Proportion

Where to start? Finding the most effective level of engagement between sponsor and provider is one of the essential tenets of a strategy for success. “You need the appropriate framework to the level of interaction, tailored to the right size engagement,” says Lind.

While it can be a virtue to err on the side of not being too anemic, like most things in life, there is always a possibility of too much of a good thing. “In fact, overloading a provider with governance or engagement can have a confounding effect despite the best of intentions if the nature of the business does not sustain or if a provider does not have the requisite level of resources,” cautions Gianelos.

Consider forming a basis by taking into account (1) the portfolio of work, (2) criticality of the service, (3) the amount of resources or bandwidth both the provider and the sponsor can devote to the engagement, and (4) the strategic plan if the path is towards growth or maintenance and development. From there it becomes a matter of sizing accordingly:

• – For engagements that are closer to transactional or of limited scope, the need might remain at periodic check-ins with minimal resource commitments.
• – Engagements that need more structure and contact, but are limited by resourcing, can benefit from a compression of activities. Consider combining touchpoints into multi-layered meetings without expectation of stratifications by stakeholder groups.
• – When both organizations have a larger commitment and deeper investment, bring forth all the robust resources and plans with multi-channel communication streams.

Proportion has another side as well: the number of engagements. “A saturation of vendors isn’t the answer either,” says Lind, continuing, “with an overabundance of vendors, it becomes very difficult to manage and rarely provides any meaningful value. Gianelos agrees noting, “When it is based on quantity and not on quality relationships, you don’t have a strategy at all.”

Right Fit Includes Thoughtful Invitation

The greatest rewards and most interesting dimensions of the engagement will be the unique aspects of the relationships built and maintained between your organizations.

As is heard often, it is people/process/technology, and the best place to start is with the people. Who might be some of the stakeholders you need to work with or who should you be aware of impacting?

“First, it should be said that everyone needs a voice along the whole chain, and it is important to represent that,” says Gianelos adding, “We do seek to stay abreast of developments in the industry. Bring in stakeholders that push the needle.” With that, both Lind and Gianelos find a strong foundation when the following elements are in the mix:

• – Members that are hands-on partnering with the service/vendor
• – The consumers of the service and/or user experience
• – Procurement and commercial functions, business and operations, and vendor strategy. (Expect business to have some of the loudest voices and/or decision obligations)
• – Executive leadership and champions

If an expanded group is available and appropriate, start with the general functional area, and then the segmentation to the functions.

Recent years have also seen the advent of Client Success Management (CSM) or similar groups that are typically on the provider’s team and charged with the mission of providing a deeper level of engagement and being a conduit for the voice of the client.

If this is a resource that is available and sized right for the engagement so as not to be burdensome, it can be beneficial. “If implemented correctly, it can be a clear value-add. CSM is very effective when serving as a mirror to Vendor Management, but it is also balanced in its voice or composition – not over-dedicated to one focus such as operations or commercial,” says Gianelos and adding, “it has to have some authority and a clear lane.”

Lind agrees and notes, “You will get the benefit if they have that neutrality and middle position and can pull together the right people. If you are going to onboard CSM, and the function is murky, it can be detrimental to the relationship. CSM needs thoughtful positioning in their organization, and not serve, or be viewed as, a redundant function.”

One caution on with whom you want to select and engage: it is easy to get lost in the tech portion of the equation. But even the best technology will not fill the gaps in your relationship or process. As Gianelos recommends, “You don’t want to go shopping for features; you need capabilities and structures that speak directly to your strategy. It also helps to keep the ear to ground and stay updated outside of the buying mode/cycle. You want narratives that are not only driven in the moment of business development.”

Right Fit Needs A Framework

With a solid understanding of who you are setting the table for in your respective organizations, the next question then becomes what is on the menu for activity and communication streams? Meaning: yes, it is time to talk about governance.

Governance is a term that sometimes can strike fear or eye-rolling, with notions of inertia adding requirements, a function that generates red tape, or rote and checkbox actions that eat up bandwidth but elude measurable progress. But the reality is that when executed thoughtfully and consistently, governance adds to momentum, and most importantly, focuses bandwidth across functional areas and organizations towards real, attainable, and measurable results.

It is also important to note that governance is not necessarily optional. “Sponsors have a regulatory obligation to show vendor oversight,” says Lind. Gianelos shares this emphasis on accountability and notes good inspection readiness needs to reflect this evidence saying, “Its outcome authored meeting minutes, demonstrating the conversations are focused on strategic direction, quality of the partnership and that a governance framework is being executed. It isn’t just showing up to a quarterly meeting and asking ‘how’s it going?’”

At this point, one may ask simply what does good governance look like? We put an outline of the essential components of structure together for reference, but there are some guiding principles that form the framework upon which all of it rests.

“It starts with taking a step back and making sure you clearly understand what you are trying to accomplish with the vendor and how it fits into that Vendor Management strategy. There needs to be a documented and mutually agreeable oversight process in place and underpinned with equally good governance internally to help guide the process, but also one that identifies and helps remove blockers from success,” says Gianelos.

Both Gianelos and Lind recommend keeping the following elements embedded at all steps:

• – Regular recognition of achievements, milestones, or goals
• – Manageable, realistic, shared ’SMART’ based goals/objectives
• – Metrics, KPIs and SLAs (which are intrinsically valuable as a measure/monitor, but also effective due to their ability to reduce emotion and encourage objectivity)
• – Identification of regular opportunities for ongoing engagement and partnership growth
• – Multi-tiered, multifaceted approaches (when appropriate)
• – Tracking and driving the actions and the results
• – Non-stop innovation
• – Mutual commitment to transparency and honesty

Right Fit Considers Business Lifecycles

Just like with our trusty pendulum, there is a natural arc or cycle to the movement of a business relationship. Typical parts of the journey include research, RFP, selections, qualifications, contracting phase, stakeholder identification, onboarding, governance stage (maintenance), deacceleration, and off-boarding.

It should be expected that depending on goals, alliance needs, forces that are external to all parties, or any host of confounding factors that can place one or both parties on different vectors, there will be different phases of lifecycle and the business relationship needs to operate accordingly. “Approach it from the idea that there are peaks and valleys, which allows you to calibrate on both sides for being more effective,” Gianelos recommends.

The shifting also is not always linear and can oscillate depending on needs. As Lind recommends, “Not every relationship has to evolve into a large structure. Prepare to have different levels and be clear about what it takes to move at different levels.”

Lind and Gianelos agree emphatically one part of the lifecycle that can never have an overabundance of thought and consideration is the onboarding or start-up. Lind underlines the crucialness of this phase saying, “The ramp-up of governance is a big call out. That initial phase is key because the first few months are very sensitive and there is too much opportunity for stakeholders to give up or develop negative feelings. Plan on putting a lot of thought and effort into to develop strategies that will set up the partnership for success. This will need patience and understanding.”

Many might prefer not to dwell on the deacceleration or off-boarding places that can occur, but that is both unrealistic and rife with peril if not taken into planning as natural events. “Shifting or off-boarding doesn’t automatically mean a negative,” notes Gianelos, adding, “It can also open the door to opportunities, or signal a transformation into consultancy or other applications. Ideally it signals the partnership achieved its objectives.” Lind and Gianelos both recommend keeping in mind that when moving pieces in or out, you must analyze risk and impact and be aware of any sensitivities or needs around contractual aspects.

Conclusion: Work Together More Mindfully

Over the course of the two parts of this series, I hope you have been provided with ample points in these reflections that resonate and inspire further consideration. By setting clear expectations and reasonable goals, making sure the right stakeholders are connected and represented, creating and maintaining a robust structure on which to manage the relationship, clients and providers can approach working together more mindfully of what structures may be needed for common success.

Thank you to McCreadie Group for this opportunity, and please feel free to reach out as we welcome further conversation!

The perspectives shared in the article are solely the opinions and industry experiences of the authors and interview participants and are not necessarily made on behalf of Regeneron or AbbVie.