While attending the annual SCOPE summit this year, listening to sessions and walking the exhibitor hall, a strong question, for me, resonated throughout the entire experience. That is, how can small biotech and pharmaceutical companies stay competitive within their realm by leveraging opportunities to advance clinical research while still navigating resource constraints?
Let’s break this down.
Large organizations are often backed by vast resources and deep-rooted market presence, often making it easier for them to leverage tools and technology to discover efficiencies and enhance their clinical research outcomes. Efficiency often means faster, and faster in clinical research, means money saved and potential speed-to-market.
Over the past few years, there has been a surge in technology and services, all offering a speedy outcome. For example, Artificial Intelligence (AI) tools can support clinical research site optimization to reduce site startup timelines, clinical trial training vendors offer protocol compliance for patients and sites to reduce risk and enhance retention, and full-service decentralized clinical trial vendors offer full data management visibility, just to name a few tactics.
But how can smaller organizations with limited resources take advantage of tools and technology (and make the right selection) with limited employees, funding, and perhaps, expertise? This question seeks to address and solve this dilemma: how to not get left behind in an environment where opportunities may not be as easily accessible for smaller organizations.
In this article, I explore considerations for the smaller players to think like big players to remain competitive and discover efficiencies without breaking the bank and ‘keeping up with the joneses.’
Step 1: Assess Roadblocks to Your Organizational Structure and Pipeline
First, take a holistic view of your company’s organizational structure and pipeline, and seek to answer the following questions around what may be preventing you from getting to market more quickly.
Step 2: Evaluate Tools and Technology Rightsized for Your Organization
Approximately 1,000 vendors attended the SCOPE summit; the exhibitor hall was full of taglines promising faster data, improved speed to market, and patient data collection tools allowing for an easier and more efficient clinical trial experience for the entire clinical research ecosystem. Hypothetically, new CEOs of small biotech or pharmaceutical companies may believe their teams could complete a clinical trial in an unreasonably fast timeline if they utilized such tools.
But what are the best practices when sorting through these options, particularly on a budget? First, ask the vendors the hard questions, including:
Then, consider the resources needed to oversee the vendor, service, or product, and assess the lift on the employee(s). Fit the technology into the company based on your strategy and priorities, but do not overhaul your company for new technology just because it’s popular. Rather, prioritize the technology based on your company’s top priorities so that you right-size your selection(s). Ultimately, this is an approach for small biotech and pharmaceutical companies to stay competitive.
Taking this critical and evaluating lens into vendor selection is essential. For example, there are more options than just the largest, more expansive Clinical Research Organization (CRO) available, and there are many vendors stating they offer similar clinical research outcomes. Since vendor selection is not a one-size-fits-all approach, if you are aligned with your strategy and priorities, that framework will successfully guide you in your evaluations and selections.
Step 3: Decide and Execute, But Not Before Developing Your Oversight Plan
So, you’ve decided to move forward with a tool or technology for your company. Before you purchase, the next important steps are developing an oversight plan and then executing on your decision.
When evaluating and selecting a new technology, assessing oversight infrastructure and processes is a must. In addition to processes, you will need to establish accountability and responsibility for oversight tasks and how those processes and tasks will be documented. In addition, you will need to determine the appropriate level of oversight required. If the oversight plan hasn’t been fully developed, this is the time to do it before implementing your new technology.
The oversight plan will outline the “who, what, and when” of bringing in a new vendor to your organization. While this plan may seem like another document, it details the communication structure between the sponsor and vendor and includes escalation pathways to follow if (and when) issues arise. The plan should outline the roles and responsibilities of individuals at both organizations, making it easier to understand peer-to-peer communication pathways. Clear timelines on deliverables should be documented, as well as the individuals held accountable.
This plan should also include a governance structure to guide and manage the sponsor-vendor relationship, as well as processes to mitigate risks and actions in real time to prevent issues from escalating, as there will be documented mechanisms to identify risks. Upon completion of the oversight plan, teams across the organizations should feel confident in their processes, enabling a roadmap to success.
A common clinical trial inspection finding by the U.S. Food and Drug Administration (FDA) is inadequate monitoring of clinical trials, so developing this plan is a critical foundational activity for the success of any trial.
In summary, when faced with many opportunities and options to enhance your clinical research processes, timelines, and outcomes, if you prioritize your employees and their journey throughout your organization, you’ll often find the best roadmap to success and stay competitive within your realm.
Passionate employees with the right skillset and mindset who believe in your company’s mission will often make as strong of an impact as the latest tool on the market. Tools, technology, and innovation are important in the clinical research space, but the key lies in the balance for small biotech and pharmaceutical companies to stay competitive and successful, especially on a budget.
To discuss your Clinical Operations and Development approach and strategy, contact Halloran.