Clinical Researcher—February 2018 (Volume 32, Issue 2)
Why today’s project leads need to evolve their role as part of strategic contract research organizations
It’s no secret that contract research organizations (CROs) are playing a larger role in supporting the clinical trial process today than even just five years ago. As the structure of clinical trials becomes more complex—with stringent regulatory requirements, a greater number of international trial sites, more assessments, and higher volumes of data to manage—life sciences companies are expanding the role of the CRO. Further, the Pharmaceutical Research and Manufacturers of America (PhRMA) organization notes that today’s clinical trials feature increasingly complicated clinical trial designs and procedures that demand more staff time and effort.1
The evolution of the CRO is driven in large part by the increased focus on novel medicines for rare diseases. In 2015, nearly half (47%) of all drugs approved by the U.S. Food and Drug Administration were rare disease drugs, including therapies for cancer, cystic fibrosis, difficult-to-treat high cholesterol, and several enzyme deficiency disorders, with currently 566 medicines still in development.2
These products provide treatment options for patients where there were few or none previously available, and while this is transformative for society, it dramatically complicates underlying clinical trials processes. Suddenly, there are more scientific unknowns, fewer specialized clinicians to serve as investigators, smaller patient populations to take part in trials, and often more complicated drug delivery mechanisms.
Wanting to remain focused on core competencies in the development of these targeted drugs, life sciences companies are leaning more heavily on contracted resources to manage processes and identify risks, remove inefficiencies, and accelerate time to market. Consequently, the role of CROs is moving from transaction problem-solver to long-term strategic partner; as a result, CROs are turning to new project management business models to support their new role.
“The move to a strategic partnership with CROs is well under way,” explained Chris Meyer, senior director of program management at Axial Biotherapeutics, a biopharmaceutical company harnessing the link between the human gut microbiome and the central nervous system to develop a new class of biotherapeutics for people with neurological diseases and disorders. “Both large and small biotechs are looking to maximize research investment by improving timelines and managing expenses through strategic CRO alliances. By creating these partnerships and intertwining them through the burgeoning pipeline, companies can gain valuable insights into ways to improve timelines and manage expenses.”
From Tactical Administrator to Strategic Partner
To keep pace with new expectations, sponsors demand that their CRO project managers (PMs) have next-level competencies. In the past, PMs followed defined processes to complete clinical activities on time and within the scope of the sponsor’s objectives. They worked according to simple management practices, adhering to the triple constraints of time, cost, and quality.3
Now, PMs must add new responsibilities for risk management, governance, innovation, and return on investment (ROI). They must have the management skills to communicate and engage with larger internal teams, external vendors, and customers. In addition, PMs must be proficient in analyzing larger subsets of data to pinpoint the outliers and report results to sponsors.
Rather than putting out fires, new expectations include proactively identifying key risk indicators that can affect trial results. Taking the role of “CEO” of the project, these leaders must look at the entire project cycle to ensure objectives are aligned with sponsors’ goals, while finding new opportunities to decrease cost and speed time to market.3
“In the past, PMs were expected to execute narrowly defined scopes of work,” Meyer notes. “Now, they must take a more holistic approach to ensure all stakeholders are working in lockstep with the project’s expectations and hitting key milestones, plus they must manage risk and foresee potential hurdles that could cause delays, costs, or even failure.”
Leslie Jones, executive director of clinical operations at ResearchPoint Global, a full-service CRO for small to mid-sized pharmaceutical and medical device companies, recognizes this new dynamic.
“PMs must be able to see risk and mitigate it before it happens, and even offer a solution before it becomes a problem,” Jones says. “The buck stops at the PM today. Because there is a variety of new technology in place everywhere across the life sciences industry, there is an expectation that PMs should be able to see everything that is happening in the trial so they can manage risk. This isn’t a new idea, but the additional expectations are. Sponsors expect CRO PMs to identify issues early, offer solutions, and effectively implement the changes.”
It’s Hard to Build a Skyscraper if All You Have is a Chisel
Despite the increase in responsibility, PMs aren’t receiving the additional training and advanced technology needed to succeed. While skillsets and knowledge of the clinical trial process are critical, PMs also need tools to support them in collaborating with different stakeholders, analyzing larger pools of data, documenting tasks, and foreseeing risk. They need a platform that supports a seamless integration with sponsor companies, providing for transparency and communications as biotech companies want to retain oversight of operations. In some cases, smaller pharmaceutical companies depend on the CRO technological infrastructure.
However, much of the existing project management tools are generic applications without specific industry functionality—think spreadsheets, e-mail, static slides, and basic file sharing systems. Limited in breadth, these tools don’t have key features PMs need to do their jobs efficiently, such as automated workflows, concurrent document review, and data management/analysis.
These legacy systems are usually incompatible with other systems, too, making it difficult for PMs to collaborate with sponsors and key partners in real time or leverage other technologies in house. Worse still, PMs often lack real-time visibility into trial processes worldwide—how can they be expected, therefore, to identify potential risk early and proactively avert problems? It’s like trying to build a skyscraper with just a chisel.
“When project or program managers are stuck using rudimentary tools that are not intrinsically integrated or designed for their needs, they end up wasting precious time updating databases and trying to determine the latest file versions or who completed what task when,” explains Meyer. “These menial administrative duties steal time away from more strategic, value-add work for the PM—yet the expectations remain the same.”
To shift from a “customer-vendor” model to a strategic partnership, both the CRO and sponsor must work on a platform that eliminates redundant work and provides a single source of truth for all players. Cloud-based enterprise project collaboration (EPC) software, for example, brings together internal and external project stakeholders onto a single platform for streamlined communication, coordination, and collaboration.
By centrally connecting pertinent information from disparate sources, EPC software enables PMs to make more informed decisions and work proactively with teams to meet objectives. The software also ensures accurate and timely, two-way transparency, so both the CRO and the sponsor know exactly what is happening at any given time.
Meredith Gartner is a senior project manager at Advanced Clinical, a clinical development organization that provides CRO, full service partnership, quality and validation, and strategic talent acquisition services for biopharmaceutical and medical device organizations. Her team uses various systems along with Excel to manage tasks and dashboards, but sees the value in project collaboration software to eliminate the arduous back-and-forth communications for status updates.
“Any system that turns the tedious, status-tracking part of this role over to a robust, data-driven system that allows team members to take ownership of their assigned tasks would dramatically improve productivity and the success of the trial,” Gartner says. “I would love a system that pulls me out of the weeds so I can stay focused on the big picture.”
According to Meyer, who implemented EPC software at a previous organization and is planning to do the same at Axial, “By combining the basic functionality of existing tools along with innovative new features designed to support the needs of an expanded job, this advanced software enables the PM to work much more efficiently and strategically. With greater transparency into processes from end to end, the PM can proactively monitor team progress and identify potential risks that can hinder progress. Overall, EPC supports a shift in the mentality of how to manage clinical trials.”
Gartner expects that today’s intense demands on clinical trial PMs will grow. “Already, people say that a PM can make or break a trial—that’s pressure,” she concludes. “Technology will make things easier in some ways—if it evolves to meet our changing needs. If it doesn’t, conversely, technology will exaggerate expectations and put PMs into a no-win situation.”
- PhRMA staff. 2011. Clinical trials—so necessary but more complex than ever. The Catalyst. http://catalyst.phrma.org/clinical-trials-so-necessary-but-more-complex-than-ever
- PhRMA. 2016. Medicines in Development for Rare Diseases: A Report on Orphan Drugs in the Pipeline. http://phrma-docs.phrma.org/sites/default/files/pdf/medicines-in-development-report-rare-diseases.pdf
- Hack V, Sackner Denise. 2017. The changing role of the CRO: impact on project management. Appl Clin Trials 26(6). www.appliedclinicaltrialsonline.com/changing-role-cro-impact-project-management?pageID=1
Andy Mehrotra (firstname.lastname@example.org) is Chief Executive Officer of EightSpokes.