Clinical research sites are at a crossroads. The demand for efficiency, transparency, and accountability has never been higher, yet many sites still struggle with fragmented processes, disconnected data, and inefficient workflows. The question isn’t whether data is available but how sites can harness it effectively to improve operations, attract sponsors, and ultimately win more studies suited to their capabilities.
Sponsors and CROs are increasingly looking for research sites that can demonstrate speed, efficiency, and reliability. Beyond sourcing sites with access to patients that fit a trial protocol, they want partners who can execute trials seamlessly, track performance in real time, and provide data-backed insights into their capabilities to instill confidence during site selection. While many research sites rely on Clinical Trial Management Systems (CTMS) to track the clinical phase of a trial such as patient visit scheduling and billing against those visits, sites often lack the tools to analyze performance trends, measure efficiency, and proactively optimize workflows. As a result, site leaders struggle to answer critical questions:
- How long does it take to activate a study after Award?
- Where are the biggest bottlenecks in our process?
- How do our past performance metrics compare to industry benchmarks?
- What makes us more attractive to sponsors?
Without a structured approach to data consolidation and analysis, sites risk missing opportunities to improve turnaround times, optimize staffing resources, and showcase their full capabilities to sponsors and CROs. Despite increasingly seeking data-driven sites able to demonstrate historical performance and operational efficiency, sponsors and CROs are reliant on sites still dependent on cumbersome spreadsheet-centric tracking methods that limit visibility and slow decision-making.
The challenge extends beyond just a site’s ability to access performance data – it’s about making that data actionable. High-performing site networks at scale are the early-adopters using real-time insights to identify inefficiencies, optimize study start-up, improve patient recruitment, and enhance financial negotiations. Those smaller site organizations that can’t benefit from these same insights risk falling behind in an increasingly competitive industry at the site level.
To unpack these challenges and explore solutions, we spoke with Barry Lake, Founder and President of Devana, a thought leader in clinical trial performance optimization. In this Q&A, Barry shares his insights on:
- The most common operational challenges facing research sites today
- How sites can leverage historical and real-time data to improve decision-making
- The key performance metrics sponsors and CROs prioritize when selecting sites
- How successful sites are using data and key performance indicators (KPIs) to streamline workflows and win more studies
There’s a reason why the industry’s leading, top site networks have already adopted the Devana cloud-based system. With deep industry experience, Barry has witnessed first-hand that sites that embrace data-driven decision-making have been – and will continue to be – the sites that stand out and thrive. Let’s dive into the conversation.
Q: What does site optimization really mean in clinical research?
Barry Lake: Site optimization is about leveraging data to improve decision-making on what trials your organization can best perform, using metrics data to both eliminate bottlenecks in clinical trial site operations or tout your site’s proficiency at rapidly progressing through study startup milestones. It’s not just about collecting or capturing data. It’s about turning data into actionable insights that allow sites to work smarter and faster. When sites have every one of their cross-functional teams fully engaged and collaborating transparently on Devana’s cloud platform, their clin-ops and executive leadership will benefit from real-time performance metrics capture for display and analysis in order to streamline operations throughout study startup and trial execution.
Q: Why is capturing timing metrics so crucial for site optimization?
Barry Lake: Well, let’s be clear about what we mean when we say, “Timing Metrics”. As site leaders know, there are a myriad of steps that a site must work through before screening and enrolling the first patient takes place. Knowing how efficiently or how “timely” your site can mobilize from start to finish through these startup milestones – or manage your “Turnaround Times” – is critical for helping the sponsor and CRO manage cycle time and the cost of the clinical trial. What are these steps or milestones? Well, there’s often a CDA or Confidentiality Agreement to execute followed by a Feasibility Questionnaire, possibly a Pre-Site Selection Visit or ‘PSV’ and that all takes place before your site even learns if you are going to receive an Award Letter! But it doesn’t stop there. Next comes the Regulatory Packet Submission Process, Contract and Budget Negotiations and, hopefully, before too long, you can get a Site Initiation Visit scheduled and reach the long-awaited “Site Activation” otherwise known as being “Greenlighted” to start screening patients against the inclusion-exclusion criteria for the trial. Many of these milestones are contingent on a site’s proficiency; therefore, one of the most significant ways sites can optimize their startup proficiency is by capturing their Timing or Turnaround Metrics during each milestone of study startup which allows leadership to analyze startup efficiency – or lack thereof – at the network level, by site, by indication but, also, by sponsor or by CRO to also assess which sponsors or CROs are the best vendor-partners to collaborate with during study startup. So, how should sites go about capturing and analyzing their Timing or Turnaround Metrics?
Sadly, many sites still rely on cumbersome spreadsheets that are accessed by multiple staff members and, therefore, subject to manual entries and formulas being overwritten which can often mean inaccurate capture of turnaround times beyond startup milestones. On the other hand, our Devana platform for built for collaboration across functional teams where your daily tracking of your duties and tasks during study startup are automated and your time to execute these tasks is visible to your teammates and leadership and when you complete tasks that you are responsible for completing such as, for example, completion of the Feasibility Questionnaire, automatic alerts in Devana then trigger your colleague who is ‘next up’ to handle the next step in the process which that colleague is accountable for completing. Transparency and accountability is how a Devana-driven site organization thrives. But Devana doesn’t stop simply with automation of each department’s study startup tasks.
As each functional team progresses through their duties and tasks during startup, Devana’s proprietary, patent-pending algorithms are triggered by each employee’s interaction with the Devana platform and, as a result, these Timing or Turnaround metrics are simultaneously calculated in the back-end of the system where they populate into dashboards and reports for operational and executive leadership to assess study startup proficiency and develop real-time insights into how efficiently (or not!) each site moves through key startup stages. These data-driven insights help sites:
- Identify bottlenecks in startup processes and correct them
- Assess where your site thrives in startup efficiency and communicate it to sponsors, CROs
- Communicate with sponsors and CROs when delays arise on their end and don’t hesitate to relay to them how their turnaround times in say, Contract and Budget Negotiations compares to their peers because, you guessed it: Devana’s platform also has algorithms to capture and calculate the turnaround times of the sponsors and CROs when your site staff throws the “ball back in their court” during startup!
This level of process and performance transparency to drive accountability is simply not available in any other clinical trial technology.
Q: How does Devana's Timing Metrics Capture work?
Barry Lake: Devana’s algorithms are triggered at each stage of study startup when a site employee performs key actions—such as simply just checking a box or adding a date stamp. These small interactions may seem innocuous, but they are critical because these actions trigger the algorithms to calculate the Turnaround Metrics which allow leadership to view dashboards and pull real-time reports to assess a site’s efficiency at every level of trial execution.
The impact? Better resource allocation, improved sponsor/CRO relations, decreased cycle time and costs and increased speed of trial completion. Altogether, these are all essential factors in an industry where clinical trial timelines, costs and speed of delivery directly affects patient outcomes.
Q: What role do site employees play in optimization?
Barry Lake: Technology is only as powerful as the team using it. “Garbage in, garbage out” as the old saying goes. For Devana’s Timing Metrics Capture and Calculations to work effectively, site employees must be proactive and engaged since the site staff trigger the algorithms that calculate the metrics and trigger the alerts to notify your colleague to get started on their startup tasks assuming they are the “next in line” to execute. The Devana Customer Success Team is world-class and they service world-class site network clients relying on industry best practices every day! For the best results using the Devana system, our CX Team coaches every site organization’s team members to:
- Understand the importance of their roles and responsibilities in study startup and execution.
- Use the Devana platform daily to track and update tasks as each trial progresses.
- Trigger alerts to keep workflows progressing smoothly from one team to the next.
- Ensure – through their consistent actions listed above – their leadership has access to accurate, real-time data to analyze performance.
Without this engagement, sites miss out on critical insights, potentially slowing down clinical trial cycle times, increasing costs and, ultimately, delaying the delivery of therapeutic advances to patients in need.
Q: How does site optimization impact the industry as a whole?
Barry Lake: Speed and precision in clinical research literally impact patient lives. When a site is optimized, it doesn’t just benefit its internal operations—it accelerates the entire clinical trial process.
A highly optimized site, therefore:
- Reduces trial delays and costs to deliver treatments to patients
- Gathers patient data of the highest quality for sponsors and CROs
- Strengthens the continuum of trust and collaboration across all clinical trial stakeholders
Ultimately, site optimization advances medicine faster and improves patient outcomes.
Final Thoughts
The future of clinical trials increasingly depends on speed and accuracy – is your site ready to optimize?
Optimizing a research site organization is about process transparency, accountability for performance and data-driven decision-making. With a platform like Devana or Devana Enterprise for the capture and analysis of both timing and patient screening and enrollment metrics, your organization can proactively streamline its workflows, eliminate inefficiencies, and position your organization as top-performing research partner to sponsors and CROs.
About RealTime-Devana
RealTime-Devana is a holistic business intelligence platform designed specifically for research site organizations, driving transparency and accountability across all functional groups. From pipeline management and streamlined study start-up through to historical trial metrics, Devana provides one source of truth for all your clinical trial data and processes. Improve turnaround times and stand out to CROs and sponsors with Devana’s powerful workflow improvements and data analytics.
Read More: Reduce Timelines in Clinical Trials – How to Standardize Study Start-Up and Capture Timing Metrics
