Technology applications are proliferating within the clinical R&D ecosystem, bringing a new type of strain on an already stretched function; namely, the outsourcing/procurement and contract management department. Point application solutions and platform approaches for almost every facet of the development pathway seem to be exploding on the scene.
From medication compliance tracking (e.g. AiCure), ePRO, wearables, eSource, and smartphone apps to patient-centric tech (for recruitment, communication, RWE applications, and home health visits), the options for technology adoption seem endless. This article explores the added demands created by technology growth on the roles and processes of outsourcing professionals.
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Technology’s rush forward is challenging our traditionally change-averse industry; both the user community and financial pressures are, in my opinion, at the root of this challenge. There are articles and news snippets daily about technology-related topics and the impact on the general trial environment.
The good news is that pharma has been taking steps to bring more of these solutions into the development path. As examples, we’ve seen this over five years in the growth of internal “innovation” departments, forays into the virtual trial model (Pfizer/Mytrus for one), and through an increase in pre-competitive collaboration among sponsors (i.e. TransCelerate).
There are also signals in some larger CRO/sponsor relationship dynamics where transparency and trust are leading to more productive discussions, focusing resources on technology solutions.
The Rising Red Flag
A continuing financial trend in R&D at large, resulting in flat or even declining headcount and budget constraints, adds to the mix of pressures. And, as targeted therapies and personalized medicine paradigms also make their mark, the increase brought in study activity without a corresponding increase in budget to execute means we are straining under the mantra of “doing more with less.” This is just as painfully felt within the development outsourcing profession where many of my peers already have more on their plates than in years past. If colleagues are able to secure funding for a new resource, timely success is not guaranteed because it’s a seller’s market. The demand from biopharma companies of all sizes is high, and we seem to have slow or even stagnated growth in the talent pool for this function.
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By GlobalDataNow, add the new challenge of identifying and working with new technology vendors, and you have a large red flag rising up. Some hope the future lies in the next generation of professionals eager to embrace new ways of moving products to market. Their familiarity with the aforementioned pace of technological change is one of the keys to our future success. However, there’s a gap here related to the critical path of development and their general understanding of it. Another contributor is the lack of breathing space to learn and adapt. Therefore, time is needed to understand the business impacts of new technology and vendors, but business continuity and deliverables do not wait on the learning curve.
Technology for the sake of it will not save anything; it is the combination of technology with an understanding of the development path that will carry us forward. And finding or training up the competencies that balance the financial, operational, legal, technological, and interactive (sometimes called “soft”) skills is costly and time consuming, but not impossible.
Encouragement by Regulators
As we continue to build out the picture, we cannot forget the facet of resistance to change by internal functions and within the larger organizational culture. It is no secret that our industry is uncomfortable with early adoption. From compliance and quality departments to the operational functions themselves, what to adopt and how to integrate new applications present significant challenges. In my experience, the issue isn’t necessarily reluctance to adopt a potentially beneficial application within a trial or program. On the contrary, it is dreading the combination of process complexity, internal multiple justifications and hurdles, and the fear of derailing a career and a multi-million dollar program on something new.
Layer on top of this the encouragement by regulators (i.e. 21st Century Cures Act, Precision Medicine Initiative, Cancer Breakthroughs 2020, BRAIN Initiative, etc.) to adopt more tech-friendly approaches, as well as the added burdens of oversight via ICH E6 R2, and we have an environment of complexity that demands increased rigor and vigilance.
As noted, we continue to see general progress toward more adoption within development, and as adoption grows, the job of identifying and managing the suppliers in question becomes more challenging. These vendors do not typically fall into the comfort category where primary CROs and familiar niche services reside. We have seen an increase of acquisitions and strategic partnerships by CROs with technology providers, and are seeing more companies pooling technology solutions through a single entity (i.e. BioClinica).
These somewhat hybrid type companies aren’t, as yet, offering core delivery services. Neither are they single service/technology companies and represent another twist for the outsourcing professional. The skills required of our departments to understand the business models these companies represent are not normally inherent, but also not completely foreign.
Straightforward Math
The process by which we assess and engage with these companies is essentially the same:
- Consult the business regarding the goals desired (point, platform, enterprise, etc.) and assemble the SME team
- Scope out an RFI/RFP (while not the same, they can be linked)
- Gather your list of vendors, collect and analyze responses, choose finalists, select, negotiate and contract
Simple, right? Yes, but not easy, and not by a long shot.
We are generally good at understanding how effort translates to cost, based on roles and rates for functions we see in traditional studies. However, what we aren’t as familiar with yet are questions about how much a support desk should cost or how much it takes to enable and run a hosted environment.
Some of these questions come down to straightforward math with people, and time and rate. Nevertheless, the difficulty comes in understanding why it takes X number of hours to design and program something. Even the most experienced development outsourcing professionals, while very good at asking the questions to help uncover what’s not on the table in a cost proposal, are still learning when it comes to these new solutions and applications. These questions can very often be nuanced to the technology under consideration. If you’re outsourcing team or your company in general hasn’t dealt with it before, you could overpay or underpay more easily.
The capacity for outsourcing teams to pick up a category and become experts is not always there. This is especially the case when other equally important engagements, such as monitoring, site management, and medical writing are also awaiting completion. Yes, work can be channeled into categories in general, however, the issue at hand is more about learning new areas that need expertise, and time tends to be an enemy not a friend here.
Addressing the High Demand
Competent outsourcing/procurement professionals in this industry continue to be in high demand. Conversely, the function itself is an early victim of budget and headcount cuts, where more work is piled onto a small group of people with little to no capacity. In my role over the past four years as the moderator of the quarterly Linking Leaders, LLC, Clinical Outsourcing Roundtable, I have repeatedly heard the pain of colleagues trying to find people who bring the whole mix of skills to the table just for the core function of outsourcing to CROs.
With the growing demand for expertise in understanding and engaging with suppliers in our technology hungry world, that search has become even harder. Yes, we see very smart lawyers, finance, clinical operations, business management, and procurement professionals do well in our function. We more often see, however, that those singular skill sets are not enough to ensure our companies are protected and our study teams are getting the right provider for the right price. It is the linking of these skills and their application to the development pathway that provides the greatest value to an organization.
