Imagine you are working or traveling away from your home when an emergency repair crops up. You can’t handle it personally, but you know someone who can – and one call to that person takes care of it.
That’s the situation I enjoy with a local tradesman. I have him on speed dial; he has a key to my house. Over the years we have become “partners of choice” – he is the person I turn to whenever I need a home repair, and he makes time in his busy schedule to ensure my job gets done. His ability to constantly deliver has earned him a steady stream of work at market competitive rates, all the while buying me much peace of mind.
A relationship like that doesn’t happen overnight. It is built on trust, mutual benefit, and shared expectations and commitment – the same characteristics that apply to any good business partnership. Merck’s clinical development areas are committed to being that kind of “partner of choice” with all of our constituencies: investigators, Institutional Review Boards, patients, payers, regulators, service providers and more.
Partnering for Patients
Being a “partner of choice” with our key suppliers is a particular priority for us. In our clinical research areas, we depend upon a host of suppliers to get new medicines through the development process and ensure they are available to the pateints who need them. We can’t do the job alone. We have to build and maintain an integrated supply network for everything from performing diagnostic tests on patients to getting clinical supplies to participating healthcare facilities worldwide.
One of our biggest needs is quickly sourcing qualified people to augment our full-time staff. We use Functional Service Providers (FSPs) for skilled professionals to perform such tasks as clinical-site monitoring activities, reviewing data and managing site-ready activities such as informed consent, budgeting and contracts. Our preferred business model is to retain core capabilities to run clinical trials end-to-end, but to do so at a level that is sustainable for the long haul. When we are blessed with the kind of situation Merck is in right now – an extremely robust portfolio with hundreds of studies underway – we turn to FSPs for additional people to fill the resource gap.
Andy Lee, Senior Vice President and Head, Global Clinical Trial Operations, emphasized the importance of quality.This type of flexible operating model allows us to scale our workforce up or down in accordance with Merck’s portfolio needs. Currently, more than half of our clinical operations’ staff comes from highly-skilled FSPs. So it is easy to see why establishing great relationships with FSPs and building a strong network for outsourcing these kinds of tasks is a true necessity for us. And, since people qualified to do these jobs are in high demand throughout the industry, ensuring that Merck is a “partner of choice” with our suppliers is a real competitive advantage for us.
Satisfying Health Authorities
That’s why Merck focuses so much time, energy and resources to ensure we have the right supplier networks in place for all of the services we outsource. This is critical to ensure we do the right thing for patients—to get them the medicines they need. It is also needed to satisfy regulatory requirements. During the past few years, health authorities have become increasingly interested in how sponsors such as Merck identify, select and oversee the clinical service providers we engage for the conduct of clinical trial activities.
Regulators have increasingly held pharma companies accountable for ensuring that their vendors are assessed for compliance, with status regularly communicated to sponsor companies according to their quality agreements. Today, it is more important than ever to ensure our use of vendors is well controlled, supported by appropriate processes and oversight, and that there is clear assignment of responsibility and accountability across all of the companies where we outsource services.
Getting to that point requires a joint understanding of how each company envisions its way forward. To that end, we held our first annual Global Clinical Development Supplier Forum in April of this year. We brought together nearly 90 people from Merck and our vendor partners for a day-long event held in Princeton, NJ. Included were FSPs, Contract Research Organizations, lab and diagnostic suppliers, and more. We spent a very productive day discussing issues and brainstorming better ways to work together, with plenty of opportunities for networking built into the agenda. The event was such a success that we anticipate holding similar sessions on an annual basis going forward.
Sharing Insights into the Business
From Merck’s perspective, the main objective of the forum was to share our company’s vision, strategy and objectives with suppliers who will help us turn those goals into reality. It was an opportunity for articulating Merck and Global Clinical Development goals to a broad audience, and for stressing our expectations for quality execution. In turn, our suppliers could take these messages back to their respective organizations and share them among their own teams. That can help us in building a shared understanding of the “why” behind the “what” we do every day, which is a necessary component in fostering commitment from employees and contractors alike.
Our sessions shared insights into how Merck is positioned for longterm growth through our innovative pipeline, business development strategies and laser-like focus on clinical programs in areas that have large, unmet patient needs: oncology, diabetes, vaccines and hospital acute care. We discussed trends in the external environment, as well as our internal challenge of meeting hundreds of milestones in 2015 to keep Merck’s numerous clinical programs on track. The fact that Merck currently has one of the most robust pipelines in the industry is great news for us. But it does present challenges in our capacity to ramp up resources as quickly as needed for all of the clinical trials we must get underway.
The forum reviewed the basics of our supplier selection, qualification, onboarding, oversight, and governance, emphasizing how overall performance could be enhanced through improved issue escalation, action-item follow up and resolution. We also discussed the need for partnering towards quality and compliance excellence, with 100 percent compliance as a critical goal.
A particular emphasis was placed on the relationship between quality and reputation, and the need for our supplier network partners to join us in being “compliance stewards” in all aspects of our business. This is a very important point for all pharma companies, since it is the sponsor of any clinical study who bears responsibility for any errors or omissions, regardless of where the compliance or quality issue may stem. Clearly we have a stake in getting things right!
Two-Way Street
The forum also recognized that being a consistent “partner of choice” isn’t just a one-way proposition. Suppliers also need to communicate their points of view and share their experiences in working with any given company. That way, sponsors can know and understand the source of an issue and what they might be able to do to better control it and ensure a positive outcome.
At the forum we gave representatives from our partner companies the chance to have their say. We did this through question and answer sessions and in smaller, breakout discussion groups. Supplier discussions ranged from defining “partner of choice” and what compliance means to their companies, to explicitly outlining what Merck does well or could improve upon. Each group summarized their discussions and reported back to the general audience in a panel discussion format.
This constructive feedback allowed us to see what “partner of choice” means to our suppliers, as well as to hear about the challenges they face in working with Merck and/or engaging their own teams on Merck’s behalf. All in, it was a day to give and receive information, share issues, brainstorm solutions, reality-set expectations, and solidify a foundation for moving forward as one team.
Moving Ahead
Feedback from forum participants showed that each side gained a clearer understanding of our joint accountabilities in bringing important new drugs to patients. Several areas of focus were spotlighted for further action, including earlier and improved visibility into Merck’s portfolio and upcoming business needs. Now the onus is on us to keep that information flowing where and when it is appropriate.
Dr. Roy Baynes, Senior Vice President and Head - Global Clinical Development, was on hand all day to meet with suppliers at the Supplier Forum.Our existing supplier governance model will help us to do so. No matter how engaging our supplier forum was, it was not a once-and-done deal for keeping us connected with suppliers and ensuring partner of choice. For that we rely on our governance model. This model provides an ongoing framework for oversight: for ensuring appropriate means are in place for both tactical direction – things like issue escalation, lessons learned, knowledge transfer and performance – as well as strategic direction. It includes reviewing the overall relationship at the executive level and planning ahead together – like true partners – to accommodate any adjustments that might be needed.
One off shoot of the forum is that we are initiating and implementing a Supplier Awards program to recognize, on an annual basis, supplier excellence in service delivery; innovative solutions; and collaborative problem-solving. On a monthly basis, we are also recognizing individuals within our supplier organizations – people who go above and beyond the basic requirements of their company’s contract with us to ensure that Merck’s priorities and needs are met. It’s a small step with the potential for big impact in keeping our contract workforce engaged and motivated.
Our award-winning suppliers represent the kind of companies Merck seeks to have as business partners. They are like the contractor who is my first port of call whenever I need a home repair! They illustrate the kind of trusted supplier that consistently delivers on Merck and our patients’ behalf. The reward for that behavior is that those suppliers get a seat at our table in discussing issues and making go-forward decisions; repeat contract renewals; and increased ability to sustain and grow their own businesses.
The benefit for Merck is that we have a solid supplier network in place that understands our business goals, shares our commitment for working together, and is ready and able to strengthen our relationship and deliver for us. That’s the kind of situation that illustrates a “partner of choice” for both parties. Patients are waiting on us to get them needed medicines. We can only do this with skilled and committed partners.
Andy Lee is Senior Vice President and Head, Global Clinical Trial Operations at Merck. He oversees the design and execution of all Merck in-patient clinical trials conducted globally, and is responsible for the tools, systems and processes needed to conduct trials through Merck staff, functional service providers, vendors and CROs. Andy previously held leadership roles at Sanofi, Genzyme and Pfizer and is currently Treasurer and on the Operating Committee at TransCelerate Biopharma, Inc.