Site selection in clinical trials is stunted, often driven by past relationships and familiarity. In fact, studies show that in any given multi-site trial, about 70% of participating sites were previously used by the sponsor1. While there are advantages to reusing known sites, like faster contracting, established workflows, and existing relationships, past collaboration doesn’t always guarantee future performance. Even with decentralized models and AI-powered tools on the rise, most sponsors and CROs still rely on manual feasibility surveys, spreadsheets, and outdated or complete lack of unbiased performance data for site selection, leading to missed opportunities.
Outdated site selection practices are a bottleneck, and the industry knows it’s a problem:
- Key factors causing study start-up delays besides regulatory and contracting hurdles include site identification, selection, and activation
- The average clinical trial runs 12+ months behind schedule and costs over $2B
What’s missing is real, objective, unbiased site performance data to help sponsors and CROs consistently select the right sites for the right trials, not just default to the ones they’ve worked with before.
The Challenge with Traditional Site Selection
Traditional site selection processes have long relied on lagging indicators: historical site data, self-reported feasibility surveys, or sponsor memory. While these inputs are better than blind selection, they’re not enough in today’s high-stakes environment. Site selection should be dynamic and data-driven, not an educated guess.
The challenge is that most systems cannot provide real-time operational metrics data. Even fewer can compare performance across sites, trials, or therapeutic indications in any meaningful way. This approach presents several issues:
- Outdated Information: Relying on historical data doesn’t reflect a site’s current capabilities or patient availability.
- Manual Processes: Paper-based, self-reported feasibility surveys or questionnaires are time-consuming, prone to errors and often out-of-date almost as soon as they are completed!
- Limited Visibility: There’s a lack of real-time insight into unbiased site performance metrics. Sites that have been selected on past studies may not be the right sites for a study today or future studies.
These challenges contribute to the selection of underperforming sites, trial delays and increased costs. At RealTime, we set out to change that.
Meet TrialAlign: Real-Time Site Selection, Built for Sponsors & CROs
We built TrialAlign to disrupt the status quo.
TrialAlign is an advanced site selection, feasibility, and performance analytics platform that empowers sponsors and CROs to make smarter decisions. TrialAlign is RealTime’s answer to the outdated site selection framework. Built from the ground up to eliminate blind spots and bring live, unbiased performance metrics into site selection, TrialAlign enables CROs and sponsors to use “blinded” or de-identified site capabilities and performance data to research top-performing sites with confidence and send them new trial invitations and feasibility and protocol details. Sites review the trial details and may accept the opportunity if they deem the study a fit based on their capabilities, backlog, and eligible patient capacity. At that point, the site identity is visible to the sponsor or CRO and a direct connection through study start-up and execution is established within TrialAlign.
TrialAlign addresses the challenges presented in site selection head-on by providing a data-driven, real-time connected-platform. Let’s unpack how TrialAlign drives smarter site selection.
How It Works
1. Direct Site Intelligence, End-to-End
RealTime-Devana, the industry’s leading site-based platform for pipeline management, study start-up automation and operational analysis, directly captures site start-up and performance data on behalf of thousands of the industry’s leading and top-performing research sites. Through proprietary algorithms and real-time data synchronization, the system continuously tracks a myriad of site start-up efficiency and screening and enrollment performance metrics including:
- Feasibility Received to Complete
- Contract Received to Executed
- CDA Executed to Greenlight/Site Activation
- Award to SIV Complete
- Site Activation/Greenlight to 1st Patient Screened
- Site Activation/Greenlight to 1st Patient Randomized
This data securely resides in TrialAlign, where it becomes the foundation for more precise site selection.
2. What TrialAlign Does with That Data
Leveraging the unbiased, de-identified site performance data captured, TrialAlign enables sponsors and CROs to:
- Query these “blinded” site profiles and performance metrics for the most-qualified sites based on therapeutic expertise, start-up efficiency, and trial performance.
- Filter these real-world metrics and send new trial invitations directly to high-performing sites.
- Sites review the trial invitations and CDA and upon acceptance, the site’s identity is disclosed and a direct connection for study start-up and execution is established through the TrialAlign platform.
The result? Better sponsor-CRO and site-alignment, faster start-up, and fewer screening and enrollment missteps, all powered by site operational metrics you can trust.
3. One View Across All Trials and Sites
TrialAlign gives you a centralized view of actual trial performance data, updated in real time. That means:
- Precise site selection
- More predictable trial execution
- Real time performance insights into currently running trials that resulted from a TrialAlign invitation
From Gut Feeling to Precise Site Selection
Many sites may look similar from the outside: same therapeutic expertise, same capabilities, same general “promise” to enroll. But as every sponsor and CRO knows, the difference between a good site and the right site can make or break your trial timeline. TrialAlign transforms the site selection and feasibility process with live, system-verified performance data, giving you real-time insight into which sites are ready, willing and able to perform. Because site selection isn’t just about finding a site – it’s about finding the right site for this trial, right now.
Want to identify high-enrolling sites with no active start-up delays? TrialAlign makes it possible. Want to understand how long a site takes to go from CDA to activation? That’s possible too. Here’s how TrialAlign stacks up:
Accelerate Time-to-Market
- Instantly see which sites have the fastest study start-up and screening and enrollment capabilities across indications
- Connect and directly align with these data-proven sites, pre-vetted to your desired metrics
- Dramatically reduce trial cycle time and cost with a smarter, data-driven platform
Optimize Trial Feasibility and Site Selection
- Leverage real-time site performance insights to refine the Feasibility and Site Selection process
- Leverage data-driven insights to identify the best sites
- Ensure every study launches on a solid foundation
Drive Better Alignment with Top-Performing Sites
- Query and select high-performing sites by indication
- Trial start-up and performance transparency to better align with sites and elevate trial results
- Deploy strategies to ensure consistent adherence to trial timelines and enrollment goals
A Win for Sites, Sponsors, and CROs
TrialAlign isn’t just a tool for sponsors and CROs. It was also designed with direct input from top-performing site networks. The industry’s strongest networks already use RealTime-Devana, the #1 clinical trial start-up, metrics-capture, and operational analysis platform that powers TrialAlign.
Devana’s proprietary site metrics data is the engine behind TrialAlign, which transforms it into unbiased, system-verified performance insights platform which sponsors and CROs can rely on for better, data-driven Feasibility, Site Selection and Trial Performance.
For site networks, that translates into real, measurable value:
- Participating TrialAlign sites are seen, shortlisted, and selected sooner for trials
- Showcase site strengths automatically – blinded site performance data can be queried and surfaced by sponsors seeking capable sites for upcoming trials
- Receive new Trial Invitations that do not already exist in your Pipeline – TrialAlign is the Business Development employee that never sleeps!
- Match with the right inbound trials to each of your sites with proven expertise in that indication
- Secure more high-value studies and boost your overall revenue potential
In other words, TrialAlign makes it easier for sponsors to find the right sites – and easier for the right sites to be found. It’s a modern, data-driven approach to Trial Feasibility and Site Selection that benefits all clinical trial stakeholders from sponsor or CRO to site to patients. Furthermore, this also means that site networks already using Devana have a strategic advantage: they’re visible and verified, automatically.
Altogether, TrialAlign is a smarter, more equitable way to connect the best performing sites with the right studies to drive better trial outcomes.
Conclusion: It’s Time to Modernize Site Selection
Sponsors and CROs don’t need more technology. They need the right technology. TrialAlign isn’t just another platform to manage. It’s a strategic shift in how Trial Feasibility and Site Selection is done. Because in today’s environment, relying on self-reported site metrics and capabilities, static surveys, or gut instinct isn’t just inefficient – it’s risky.
TrialAlign delivers a transformative approach to Trial Feasibility and Site Selection replacing outdated assumptions with real-time, performance-based data. It taps metrics directly from the core operational platform already in use across thousands of top-performing sites, giving sponsors and CROs access to enrollment velocity, site capacity, start-up timelines, and more. And when that kind of clarity drives Trial Feasibility and Site Selection, patients get access to therapies faster. That’s the outcome we’re all working toward.
Footnotes
1Tufts Center for the Study of Drug Development. (2018, March/April). Clinical Site Initiation Process Remains Lengthy and Highly Inefficient. Impact Report, 20(2).