Author: Barry Lake, Co-founder of RealTime-Devana
The Dual Mission of Academic Medical Centers
Academic Medical Centers (AMCs) have long been pillars of innovation and discovery in clinical research, driven by a mission to advance science and improve patient care. However, while the prestige of groundbreaking research is invaluable, it’s increasingly clear with NIH grant funding now under the political microscope that the shift by AMCs to sustainability and profitability that was underway before today’s headlines is essential to maintaining robust research programs. Our fine academic institutions must always be the bastions of the relentless pursuit of advancing novel treatments and finding cures that once seemed impossible, suddenly, not only possible, but often the new standard of care.
Why Profitability Matters Now More Than Ever
These noble research endeavors to better the condition of humankind should always be supported in our institutions of higher learning regardless of the monetary cost and, quite candidly, I believe our federal government should retain a leading role in funding research with a positive societal payback especially where, absent the profit motive, the biopharma industry will not act. However, at the same time, I would argue that AMCs, in general, should increasingly look today for ways to shift an ingrained altruistic institutional mindset toward transitioning at least some clinical research they undertake away from being a cost center and reorient their focus on becoming strong revenue generators if not profit centers.
Evolving the AMC Mindset: From Cost Center to Revenue Generator
Such a transformation at our AMCs requires strategic operational changes and buy-in from administrative leadership right down to the Investigators and clinical staff, especially those study teams focused primarily on industry-sponsored clinical trials. Transformative change in the clinical research done at AMCs also requires the adoption of tools and systems that can maximize the efficiency of trial management across therapeutic departments and individual clinical study teams. To achieve success at our major AMCs in driving the level of process and performance efficiency required to move their industry-sponsored research towards profitability requires an unwavering commitment to transparency and accountability from top-to-bottom, administrative leadership down to clinicians. In addition, unprecedented scrutiny of clinical trial feasibility and selection, especially of actual trial enrollment performance and, as a direct result, revenue generation, within a culture at many AMCs not always welcoming to performance-based scrutiny of trials that have traditionally been selected and pursued by Physician Investigators not in collaboration with Administrative Leadership.
A Proven Model Born From Site-Level Challenges
As the former site owner of an independent research site with first-hand experience in the daily struggles and challenges confronting clinical trial site managers, I initially founded the Devana system to gain transparency into the performance of my own independent, for-profit research site. We eventually expanded our use of Devana to include a network we assembled of affiliate sites with a wide array of different therapeutic strengths. After we launched Devana Solutions commercially almost a decade ago, our first major client who we are proud to count as a loyal client to this very day, was the team that managed feasibility on all inbound industry-sponsored clinical trials at Medical University of South Carolina, one of the largest research AMCs in the U.S. located right in the backyard of our independent research site in Charleston.
What CTMS Missed - and What Devana Solved
Clinical Trial Management Software or Systems (“CTMS”) came into existence more than a decade before we created Devana Solutions but, unfortunately, as the first letter of this acronym would clearly imply, the automation provided by CTMS to research sites and institutions was predominantly “clinical” in focus but lacked any standardization or automation of the myriad of clinical trial startup procedures that occur in the weeks and months before any ‘clinical’ activities even begin. Moreover, as the biopharma industry well knows, efficiency in mobilizing the study teams at hundreds and often thousands of research sites through the progression of trial feasibility analysis, regulatory submissions and contract and budget negotiations and all other trial startup milestones that represent the “business side” of conducting research, is one of only two ways to reduce clinical trial cycle times and costs. Save for more rapidly identify and screening patients eligible to be enrolled in a clinical trial, efficient clinical trial startup is the only other way to shave critical days and weeks off the timeline to gain approval for therapies proven clinically safe and effective.
In 2023, our Devana system was acquired and became part of the larger RealTime-eClinical Solutions company. As a result, access to greater resources helped Devana further its mission to standardize study startup ‘best practices’ and automate study startup workflows while simultaneously capturing site performance metrics for display and analysis. Devana not only uncovers process bottlenecks and inefficiencies but also allows operations and executive leaders to identify operational strengths and trial performance prowess by therapeutic indication. This positions organizations to be proactive in reacting to the constantly shifting operational and therapeutic alignment with each industry sponsor and CRO on whose behalf your site-based staff are actively running clinical trials.
Measuring Performance Drives Performance
Studies have historically shown that simply having a system in place to constantly measure performance has the effect of improving performance. Markedly, the Devana system to measure clinical trial startup and enrollment performance efficiency proves this time-honored truth. Today, virtually all of the leading independent, for-profit research organizations that predominantly execute clinical trials for the biopharma industry leverage the Devana metrics-capture and analytics platform as core to their pursuit of clinical trial efficiency and, as such, their profitability and growth.
Today, with the federal government’s role as a major funding source for clinical research in question, at least in the near to mid-term, Academic Medical Centers are increasingly shifting their focus towards industry-sponsored research and the Devana system will no doubt be at the forefront of these efforts. Devana is a large part of the answer to the critical transition by AMCs striving to balance their mission to advance science and improve patient care alongside the need for financial sustainability. Here’s how AMCs can leverage technology, like RealTime-Devana, to turn clinical research into a profitable enterprise.
Accelerating Clinical Trial Cycle Timelines
Lengthy trial start-up timelines can erode profitability, frustrate sponsors, and hinder operational efficiency. From navigating contract negotiations to securing regulatory approvals and recruiting participants, every delay represents a missed opportunity to reduce costs and build stronger sponsor relationships. Addressing these inefficiencies is crucial for AMCs to shift from viewing clinical research as a cost center to establishing it as a sustainable and profitable enterprise.
The Problem: AMCs often face lengthy timelines in study start-up due to fragmented communication, outdated processes, and a lack of centralized oversight. Contract negotiations can drag on without clear visibility into bottlenecks. Similarly, regulatory approvals may be delayed due to misaligned priorities or inefficiencies in documentation and follow-ups. Participant recruitment, a common pain point, can lag due to a lack of actionable insights into patient availability or recruitment trends. These delays not only frustrate sponsors but also increase operational costs, reducing the overall financial viability of clinical research programs.
The Opportunity: Devana is a holistic business intelligence platform, purpose-built to drive transparency and accountability across all functional groups. The system provides centralized visibility into every step of the trial start-up process, enabling research teams to monitor and manage critical milestones in real time. By integrating Devana’s end-to-end tracking and management capabilities, AMCs can bring precision to their clinical trial operations. For example:
- Contract Timelines: Devana enables AMCs to monitor contract progress, track negotiation status, and ensure that tasks are completed on time. With a 76% reduction in contract and budget turnaround time, Devana provides the visibility needed to eliminate unnecessary delays and hold stakeholders accountable, ensuring trials stay on schedule.
- Regulatory Approvals: Delays in regulatory submissions can stall trials before they even begin. Devana provides tools to track submission and approval timelines, ensuring nothing slips through the cracks.
- Key Milestones: From site activation to study start-up, Devana allows AMCs to monitor every critical step, reducing inefficiencies and keeping trials on schedule.
The Impact: By addressing these inefficiencies, AMCs can significantly reduce trial cycle timelines. Faster start-up means AMCs are better positioned to achieve milestones on schedule and meet sponsor expectations. This not only enhances sponsor satisfaction but also reduces overhead costs tied to prolonged timelines. Improved operational efficiency ultimately turns clinical research into a more profitable venture, enabling AMCs to reinvest in further innovation and patient care.
A Centralized Solution for Smarter Project Management
Managing complex trial portfolios is one of the biggest challenges facing AMCs. Balancing investigator-initiated, grant-funded, and industry-sponsored studies – each with unique requirements – can strain resources and create inefficiencies. Without a centralized system, trial management often results in disjointed workflows, duplicated efforts, and missed opportunities to optimize operations.
The Problem: AMCs typically operate across multiple departments, each handling different aspects of a clinical trial. This siloed approach can lead to communication gaps, redundant tasks, and challenges in resource allocation. For example, staff may find themselves overburdened with administrative tasks or unaware of overlapping schedules, while decision-makers lack a clear, real-time view of overall operations. These inefficiencies delay timelines, can compromise sponsor relationships, and reduce the financial viability of research programs.
The Opportunity: Devana centralized platform is specifically designed to address these challenges. With its 360-degree view of clinical trial operations, the solution empowers decision-makers at AMCs to streamline workflows and make more informed decisions.
- Streamlined Resource Management: By centralizing data, the platform enables AMCs to allocate staff, equipment, and other resources more effectively, ensuring that each study receives the support it needs without unnecessary overlap.
- Workflow Optimization: Devana reduces bottlenecks by automating processes like contract management, regulatory tracking, and task assignments. This ensures studies stay on schedule and within budget, minimizing disruptions caused by manual errors or delays.
- Tracking Performance Metrics: Devana provides real-time visibility into key metrics like recruitment rates, study progress, and resource utilization. This helps AMCs identify inefficiencies and optimize performance across portfolios.
The Impact: With Devana, AMCs gain the transparency needed to proactively manage their trial portfolios. This improved oversight prevents resource misallocation, reduces redundancies, and boosts collaboration across departments. The result is a more streamlined and cost-effective operation that ensures trials are executed on time and meet sponsor expectations.
By adopting Devana, AMCs can transform their clinical trial management from a fragmented, resource-intensive process into a cohesive, highly efficient system. This not only improves operational performance but also strengthens their position as leaders in advancing medical research.
Data-Driven Decision-Making
Profitability in clinical research requires a clear understanding of where revenue is generated and where inefficiencies lie. For many AMCs, the challenge stems from a lack of tools to effectively analyze performance data and establish oversight across their trial portfolios. Without actionable insights, identifying and addressing inefficiencies becomes a guessing game.
The Problem: AMCs often manage multiple trials simultaneously; however, fragmented data and outdated processes can obscure critical metrics like enrollment rates, budget turnaround times, and study activation milestones. This lack of visibility makes it difficult to evaluate study performance, pinpoint areas of operational inefficiency, and identify opportunities for growth.
The Opportunity: Devana captures and displays key performance metrics in real time, providing AMCs with a centralized dashboard for data analysis. With actionable insights, AMCs can:
- Monitor Enrollment Rates: Identify recruitment bottlenecks and track progress to enrollment goals.
- Streamline Study Start-Up: Track timelines for critical milestones, such as contract negotiation and site activation, reducing delays.
- Evaluate Study Performance: Compare metrics across studies, departments, and therapeutic areas to identify top-performing areas and opportunities for improvement.
The Impact: Armed with this data, AMCs can make informed decisions to optimize their trial portfolios. High-performing studies or departments can be recognized and resourced more effectively, while underperforming areas can be reevaluated or adjusted. By focusing on profitable therapeutic areas and replicating successful practices across the organization, AMCs can improve their efficiency and overall financial sustainability.
Final Thoughts
Profitability doesn’t mean sacrificing the core mission of advancing science and improving patient care. Instead, it’s about creating sustainable research programs that support long-term innovation. For AMCs, clinical research can and can be more than a prestigious endeavor. It can be a source of sustainable revenue that fuels innovation and supports the academic mission. Purpose-built solutions like Devana enable AMCs to optimize resources and turn clinical research into a profitable enterprise.
About RealTime-Devana
RealTime-Devana’s business intelligence platform transforms clinical trial operations by standardizing processes which helps reduce cycle times. Turn research into a profitable enterprise with improved project management across multiple teams and departments, automated study start-up workflows, and real-time data capture and analytics.
