When a sponsor listened to site feedback and adapted workflows, patient data arrived faster and site satisfaction soared.
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Designed to ensure protocol compliance while providing sponsors with real-time access to high-quality data, TruTechnologies' solution goes beyond sample tracking and data transmission. By offering hands-on training and ongoing site support, TruTechnologies helps sites identify workflow pain points early on, facilitating prompt action by the sponsor.
This case study highlights TruTechnologies' role in strengthening the relationship between sites and sponsors by creating a feedback loop that improves site efficiency while ensuring protocol compliance and data transparency.
Investigational sites are not just the operational backbone; they are the lifeblood of every trial, playing a pivotal role in ensuring that studies are conducted effectively, data is collected accurately, and patients receive the care they need throughout the process.
However, the performance of these sites is ultimately only as strong as the quality of information they receive from the sponsor. Clear communication and well-defined protocols are crucial for ensuring that sites can execute trials efficiently and meet study objectives. As Jeff Kingsley, CEO of a clinical research network based in Columbus, Georgia, notes, “If sites and sponsors become more strongly connected, we could better support the tremendous growth happening throughout the industry. Bridging the communication gap is critical to this.”1
Still, this is often easier said than done. As the sheer volume of clinical studies continues to balloon each year, not to mention the complexity of accompanying protocols, sites often feel left out to dry. While many sponsors are turning to contract research organizations (CROs) to help manage these complexities and give sites the focused support they need, there are limitations without tailored technological solutions that allow stakeholders to have virtual eyes and ears on the ground. No matter the level of experience, no CRA can see what’s happening at every patient visit and proactively reach out with assistance if necessary.
This is precisely why a growing number of sponsors are likewise turning to TruTechnologies. The technology isn’t just a tool for seamlessly tracking biosamples and electronically recording and transmitting all requisite source data; nor is it just a tool for ensuring protocol compliance through guided workflows and real-time deviation detection.
Because each deployment of the software includes hands-on training tailored to each site’s specific workflow as well as ongoing protocol support by TruTechnologies' site care team, it creates a robust, multidirectional communication channel between sponsors, CROs, and sites, essentially reconnecting the heart and brain of every trial. Sponsors can now be responsive to the needs of sites within days rather than weeks or months, and sites can trust that they have the resources needed to maintain high quality study conduct at all times.
When a sponsor running a multinational, Phase 3 rare disease study employed TruTechnologies to ensure protocol compliance across its various sites, it didn’t take long before the technology began to demonstrate its value. On the Friday before a major holiday weekend, the TruTechnologies team learned that the very first screening visit of the study was in progress and that the site was experiencing significant challenges.
A Friday visit meant that a critical screening blood sample requiring overnight incubation would need to be processed and shipped outside standard operating hours. To support the site, TruTechnologies' in-house team provided real-time guidance on the correct processing timeframe and ensured staff would be available the next day to manage logistics.
Communication then continued throughout the long weekend as site staff realized they lacked the necessary information to create shipping labels, meaning none of the samples from this first patient’s visit could be shipped as outlined in the lab manual. In addition to alerting the sponsor that some of the samples would fall outside of stability windows, TruTechnologies also acquired and forwarded shipping instructions so the site could ship early Tuesday.
Not only did these steps help the site get back on track and ensure the patient remained eligible for inclusion, but it also deepened the relationship between TruTechnologies and the site. TruTechnologies' hands-on approach and real-time problem-solving fostered trust and collaboration, allowing the site to feel supported through each step of the process. What’s more, this close collaboration provided TruTechnologies with unique insights into the site’s workflow and operational pain points — insights that likely would not have surfaced through standard interactions and traditional communications alone.
This nuanced understanding, however, wasn’t limited to this initial site. TruTechnologies maintained close contact with each of the dozens of sites in the study, likewise offering tailored training and addressing emerging challenges. Whenever TruTechnologies identified an issue, such as those uncovered during the Friday screening visit, the team proactively shared insights with all study sites to prevent similar problems from occurring.
But TruTechnologies didn’t just facilitate lateral communication; the team also ensured these valuable insights reached the sponsor. In regular progress meetings, TruTechnologies relayed site-specific challenges and offered actionable strategies to improve site experiences, creating a proactive feedback loop that led to swift changes benefiting both sites and sponsor alike.
Each iteration of the TruTechnologies app is designed with two main goals in mind:
1. To provide site users with easy-to-follow, up-to-date protocol guides
2. so that sponsors have access to the highest quality data as soon as the patient is seen.
But this isn’t accomplished by just plugging the protocol’s schedule of assessments into a digital format and calling it a day. For each site to be truly successful, individual site workflows must be accommodated, and while TruTechnologies' site care team can generally help sites mitigate potential difficulties through hands-on training, more substantial interventions are sometimes merited.
In this large rare disease trial, with multiple sample types collected both at clinical sites and patients' homes over a six-week screening period, it quickly became evident that a more flexible approach to sample logging and data collection was necessary. Initially, TruTechnologies was asked to configure the schedule of assessments so that the first screening visit involved logging both blood draws and a previously collected 24-hour urine sample.
However, 93% of sites found this workflow to be inefficient, as it required an in-person pre-screening visit just to provide at home collection supplies. This also meant unnecessary delays in gathering other patient data needed for determining eligibility, which is why the vast majority of sites were opting to take blood samples when the patient came in to collect their supplies, bypassing the original process.
While skipping ahead to the next visit’s assessments did not violate the protocol — since these samples weren’t required to be collected together — it caused confusion among sites because the workflow in the app didn’t match their needs. Recognizing the urgency, TruTechnologies quickly conveyed this feedback to the sponsor just days after the First Patient In visit (FPI) and proposed a solution: a configuration update to accommodate both workflows. Seeing the value in this adjustment, the sponsor agreed, and TruTechnologies promptly made the necessary changes.
Not three weeks after the FPI, sites were pleased to receive the following email from TruTechnologies: “Hope you're having a nice start to the week! We're excited to share that [the sponsor] has heard your feedback on the typical workflow for these screening visits, and TruTechnologies has now developed an enhanced workflow in the app for pooled urine samples collected during the screening period. Below, you'll find a list of enhancements that have been made to your configuration of the TruTechnologies application, and you will see these updates reflected in the app at future screening visits, starting today.”
Not only did sites now have the flexibility to conduct screening visits in their preferred order, but these changes also allowed the sponsor to have access to patient data much sooner than before. Because sites had been unable to close the first patient visit in the app due to the outstanding 24-hour urine samples, the associated data from those visits wasn’t being relayed to the sponsor until the patient returned, sometimes more than a week later. Now the sponsor could see everything — when the patient was first seen, what samples had been collected, when urine supplies had been provided, and importantly, when that patient was expected back in — all in real time.
Site feedback also dramatically improved following the changes. “Thank god,” said one coordinator when discussing the enhanced workflow with TruTechnologies' team. “This makes my life so much easier.”
TruTechnologies' involvement in this Phase 3 rare disease trial underscores the importance of creating adaptable, site-friendly systems to ensure the success of complex clinical trials. Through real-time communication, hands-on support, and proactive reconfiguration of workflows, TruTechnologies enabled both sites and the sponsor to operate more efficiently, resulting in improved relationships, faster data collection, and better patient outcomes. By fostering this level of responsiveness and flexibility, TruTechnologies helps bridge the gap between protocol requirements and site realities, ultimately ensuring that clinical trials can be conducted smoothly and without unnecessary delays.
1. Burks, B. (2020, January). Leave no site behind: How sites, sponsors, and CROs can speed clinical research together. Clinical Researcher, 34(1).
