Maria DiPietro is senior vice-president, Operational Solutions Architect & Strategy, ICON Strategic Solutions.

Maria DiPietro

Two scientist or medical technician working, having a medical discuss meeting with an Asian senior female scientist supervisor in the laboratory with online reading, test samples and innovation | Image credit: © Nuttapong punna - stock.adobe.com

Partnership is an increasingly important criterium for bio/pharmaceutical sponsors as they seek more bespoke solutions and the flexibility of tailored, blended outsourcing models. Sponsors are consolidating their vendors and utilizing fewer contract research organizations (CROs), but with more expansive and aligned partnerships to find solutions to clinical research challenges and improve their R&D return on investment.

The consolidated CRO landscape, wherein the top CROs capture 70% of total clinical outsourcing spend (1), provides sponsors with large CROs offering fuller suites of services and broader geographic footprints, effectively shifting more importance onto their ability to deliver as partners. This move toward more meaningful partnerships has fueled additional evolution in the CRO-sponsor outsourcing landscape, including in the ways progress and success are measured.

Elaborations on outsourcing methodologies

Over the past two decades, the clinical research landscape has witnessed a significant transformation due to rising protocol complexity and the broadening scope of trials. In response to these changes, outsourcing methods have evolved, adapting to meet the demands of modern clinical research. As such, traditional models such as full-service outsourcing (FSO) and functional-service provision (FSP) have been reshaped to better accommodate new methods in addition to the proliferation of models that go beyond this distinction. This proliferation of new models reflects an ongoing trend in partnership development, fostering deeper, more meaningful collaborations. These collaborations, in turn, have given rise to customized, tailored, and hybridized models that can cater to the unique requirements of each study as scientific and regulatory considerations must be balanced with concerns around addressing patient access, diversity, and patient-centricity.

. Recent data from the Tufts Center for the Study of Drug Development (Tufts CSDD) underscores the dominance of the FSP model in current clinical trial outsourcing. In fact, nearly half of the clinical trials analyzed within the Tufts sample—comprising 117 trials across nine sponsor companies—utilized the FSP model. This represents a significant shift, as just a few years ago, FSO was the prevailing model for more than 77% of sponsor companies (2).

The popularity of FSP aligns with the growing importance of strategic partnerships. FSP offers sponsors greater control and ownership of key assets, a critical factor as clinical research becomes increasingly complex and risk-laden, while the cost of conducting trials continues to soar. According to 2023 ISR Reports, the average spend on clinical trials is expected to continue rising across Phases I–III for small, mid-size, and large sponsors (3). The outsourcing spend as a percentage of these costs will go hand in hand with these increases, likely resulting in additional innovation within the methods used.

. Collaboration between CROs and sponsors has transcended the conventional contract-execution models of the past. While the FSP model remains popular (4), especially among mid-size and large pharmaceutical partners, there is a notable trend toward blended models and tailored solutions.

Today, CROs position themselves as true partners, offering flexibility, consultative support and a deeper level of engagement to meet the evolving needs of sponsors in the face of increasingly complex clinical trials. In parallel, sponsors are embracing a more fluid relationship, characterized by shared governance, common objectives, and greater integration.

Biopharmaceutical sponsor companies will employ combinations of outsourcing methods even within single departments. They may leverage different models or levels of partnership complexity with different vendors or even with just one CRO across multiple scopes, strategically blending solutions. These adjustments in outsourcing strategies reflect the industry’s commitment to adapt and innovate in response to the evolving landscape of clinical research.

Merger and acquisition (M&A) activity in the CRO landscape can be understood as a function of the evolution from single-service provision to integrated, end-to-end solutions providers, and strategic partners. CROs must keep expanding capabilities to offer a “full suite” to their sponsors. And—as is common knowledge in the clinical research industry—the quickest means of innovation or portfolio expansion is acquisition.

The CRO landscape saw a significant year for M&A in 2021. According to 2022 Tufts data, the top clinical CRO segment had a record year in terms of the number and size of the recorded M&A activity, with 13 total transactions. As noted, between 15% and 25% of all M&A transactions in the CRO landscape reflect the pursuit of “novel” or less-traditional capabilities (1). In recent years, this has included augmented analytics and artificial intelligence in addition to technologies and solutions to enable decentralized clinical trials.

. CROs are also engaging in M&A as a means for expanding their footprint to better meet sponsor needs. For example, this could facilitate the ability to move strategic roles into regional hubs or offer lower cost settings. CROs are expanding their networks in ways that allow for more strategic control in these key target areas. However, this expansion is a double-edged sword. Tufts research notes that the inclusion of more countries and more investigative sites contributes to overall execution burden by compounding the complexity of the trial (5).

Intentional, strategic geographies are an important consideration for sponsors. Sponsors are evaluating their footprints for further rationalization while simultaneously seeking to expand into new geographies. They rely on their CRO partners to weave in their own footprint to extend the reach of their trial. The outsourcing models employed in this situation will likely leverage blended services where the CRO can fully support the conduct of the trial in those areas.

. CROs have broader perspectives and insights by nature of their position working across many therapeutic areas, modalities, geographies, etc. In working with a wide range of sponsor companies, CROs often gain a depth of experience and lessons learned that can positively benefit other programs when translated across outsourcing relationships. Sponsors are increasingly interested in leveraging the strategic value of these partnerships, turning to CROs for an infusion of those proven best practices and strategies and collaborating to create leading edge models to optimize delivery.

. In addition to acting as a library for best practices and lessons learned gained from direct experience with sponsors across the industry, CROs are driving adoption of advancing technologies and innovations.

In the modern research landscape, digital technologies are a crucial part of the ways in which sponsors and CROs are delivering and transforming clinical trials. The latest transformational technologies include quantum computing, blockchain, organ-on-a-chip, advanced statistical modeling, Big Data, and artificial intelligence (AI). To better understand sponsors’ attitudes toward these technologies, a survey was conducted among 350 pharma and biotech professionals. When asked “How much do you anticipate digital technologies improving R&D productivity?” 99% believed that they will see significant improvements (6).

The increasing cost and complexity of running clinical trials underscores this drive to leverage technology for efficiency and optimization, but it also adds challenges. Layering complicated tech onto already complex studies has the potential to become detrimental to overall processes. CROs have developed platforms and interoperable technologies to streamline this complexity and have invested both in tech and their personnel expertise to optimise and simplify these processes. Sponsors rely on this balanced, complex basketweave of processes and technologies to enable their trials.

. Of the transformational technologies, Big Data and AI are gaining the most traction. Big Data, and specifically a CRO’s access to data, offers invaluable opportunities for improving clinical research. Extracting meaningful insights from vast data requires computational capabilities to match, thereby driving progress in AI technologies. AI innovations include machine learning and deep machine learning, robotic process automation, and other expert systems that enable CROs to capture, consume, and interrogate more data with more impactful processes.

When it comes to data, the Tufts study found that FSP is now the most common model for both clinical monitoring and data management. These are highly technical areas that are exceptionally labor-intensive, carrying associated study costs. The FSP model can help to reduce costs and improve efficiencies, so employing this model for clinical monitoring makes sense for most sponsors considering this area alone can represent 35–45% of clinical trial costs (4).

. Another new outsourcing development takes the shape of joint innovation agendas. CROs may offer these models to allow larger pharma sponsors to pilot innovations within the structure of a consultative partnership, minimizing some of sponsors’ inherent risk while allowing them to benefit from their CRO’s experience and expertise. ICON has seen an increased interest in this model among its large pharma partners, and it is expected that this trend will continue.

Although CROs often work toward the same goal—bringing meaningful therapies to patients—no two organizations operate the same. As outlined previously, even the outsourcing methods used within a single partnership can vary. However, the lessons learned from one partnership can inform potential models or solutions for another. In this way, CROs can pilot and refine the methods used within partnerships to achieve harmony.

CROs often assume the role of change managers. Implementing digital solutions and new technologies may require new trainings or optimized organizational workflows to accommodate the new capabilities. Both CROs and sponsors must dedicate time and resources into building strong, trusting partnerships that allow for seamless integration. These relationships must also be backed by deliberate processes, controls, and governance structures to support joint operations and allow for clear measurement against shared goals.

. Tracking the success of a partnership operating within a new outsourcing model may be challenging. A selection of carefully identified partnership metrics representing these key categories can lead to mutual success in strategic partnerships. Four foundational categories for partnership metrics can provide meaningful data to guide decision-making: finance, quality, operations, and relationship health. Based on the specific goals, deliverables and context of each partnership, more granular key performance indicators can be selected for each of these metrics categories to provide the clearest mechanism for evaluating performance.

The bespoke solutions and continued evolution within clinical trial operations and the technologies they utilize will continue to fuel progress among outsourcing models as driven by CROs. While there are some overarching trends, CROs are tailoring their solutions and models to meet each organization’s unique business needs and they are leading partnership alignment to ensure predictable delivery with the highest quality standards. Looking forward, the author expects increased adoption of blended solutions and deeper and more meaningful strategic partnerships among industry players. In addition, there will be further development around benchmarking and standardization of models and terminology to allow for robust business cases informed by custom metrics.

Tufts. Impact Report: Analysis & Insight into Critical Drug Development Issues. 

 CSDD. Volume 24, Number 6–November/December 2022

Getz, K. Insights into Outsourcing Practices and Oversight Effectiveness. 

2023 CRO Market Size & Growth Projections. Industry Standard Research, 2023.

Lamberti, M.J.; Smith, Z.; DiPietro, M.; Barry, J.; Getz, K. Outsourcing Model Usage and Its Relationship to Clinical Trial Performance. 

 CSDD. Volume 25, Number 3–May/June 2023.

ICON Digital Disruption Survey. Digital Disruption in Biopharma How Digital Transformation Can Reverse Declining ROI in R&D.

When referring to this article, please cite it as DiPietro, M. Elaboration, Expansion, and Evolution in Outsourcing of Clinical Research. 

Articles

The rising complexity of clinical research protocols has necessarily expanded the CRO landscape. 