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Addressing Clinical Trial Sponsor Needs with Technology

Digital solutions can enable an efficient and cost-effective clinical trial while also enhancing participation and compliance.

As the clinical trial landscape evolves, digital technologies are transforming how MedTech (medical device and in vitro diagnostic (IVD)) sponsors conduct clinical research, streamline processes, and achieve better outcomes. In this exclusive Q&A with MPO Magazine, Beaufort’s Karin A. Hughes, Ph.D., Senior Vice President of Global Regulatory & Quality, and Bill Trembley, Senior Vice President and Chief Technology Officer, share their expertise on leveraging innovative digital tools to improve trial efficiency, enhance patient engagement, and meet the unique challenges of today’s MedTech environment. From optimizing workflows to addressing regulatory considerations, their insights provide valuable guidance for sponsors looking to succeed in an increasingly technology-driven field.


As Appeared in MPO Magazine with Sean Fenske, Editor-in-Chief:

In today’s fast-paced MedTech landscape, clinical trials are evolving rapidly spurred by the creation and adoption of innovative digital technologies. For medical devices requiring clinical trials to support regulatory clearance or approval, the stakes are high. Manufacturers want to ensure they are maximizing trial efficiency and are increasingly seeking the best tools to streamline processes and enhance trail outcomes to help them achieve positive results.  

Digital technologies can be leveraged to help achieve this goal. There are a number of solutions that are proving invaluable across all trial phases, from improving participant recruitment and informed consent processes to simplifying clinician workflows and enabling better data collection. Similarly, other digital offerings can improve diversity among participants and address barriers faced by underserved communities However, there are considerations to take into account with digital tools, as well.

Speaking to  the range of benefits and consideration   when using digital technologies to assist with clinical trials is a pair of experts from Beaufort, a CRO specializing in MedTech solutions. In the following Q&A, Beaufort’s Karin Hughes, Ph.D., Senior Vice President of Global Regulatory & Quality, and Bill Trembley, Senior Vice President and Chief Technology Officer, took time to respond to several inquiries on this topic to provide insights on utilizing technology to support sponsors and help clarify any uncertainty.

Bill Trembley: The rapid advancement of digital technologies in clinical research offers significant opportunities to improve processes and deliver value for medical device stakeholders. At Beaufort, we are continually evaluating how and where technology can be best leveraged to meet our clients’ unique needs. By streamlining workflows, improving data accuracy, and enabling real-time insights, these innovations drive greater efficiency, reduce administrative burdens, and accelerate timelines, ultimately supporting the success of clinical trials.

Mainstay technologies such as electronic trial master files (eTMF), eSource, and electronic data capture (EDC) systems play a critical role in medical device trials. However, we don’t believe in a one-size-fits-all solution.

Instead, we focus on identifying the right combination of systems tailored to each study’s specific requirements.

This includes seamlessly integrating any legacy systems the sponsor may already use and recommending complementary tools that add value. This approach ensures all technologies work cohesively to achieve goals like improving data accuracy, enabling real-time monitoring, or expediting decision-making.

We know digital technologies now support every stage of the clinical trial process. During the startup phase, site feasibility platforms streamline site activation and participant recruitment, keeping trials on schedule. Tools like eConsent simplify the informed consent process by enabling remote access and fostering greater patient enrollment. Throughout execution, systems like direct data capture minimize manual errors, while automated data cleaning at closeout accelerates database lock and reduces delays. Furthermore, innovations such as wearable devices, remote monitoring platforms, and artificial intelligence enhance the ability to capture real-world evidence and uncover trends that inform better decision-making.

What sets Beaufort apart is our emphasis on integration and customization. By tailoring solutions to each sponsor’s needs and ensuring systems work seamlessly together, we empower our clients to achieve more efficient trials, higher-quality data, and greater confidence in their results.


Trembley: Based on our experience and broad industry data, we know technology can significantly enhance patient engagement and satisfaction. Patients generally feel comfortable with electronic consent technology, which has been shown to improve comprehension compared to traditional paper-based methods. For those who prefer traditional options, we ensure paper-based consent remains available, respecting diverse patient preferences and accessibility needs.

The U.S. Food and Drug Administration (FDA) recognizes that digital tools, when implemented thoughtfully, not only improve engagement but also enhance trial design and conduct. These tools allow for the incorporation of patient input, making trials more patient-centric and increasing enrollment and retention by addressing individual needs and preferences. Digital health technologies (DHTs), such as remote monitoring platforms and wearable devices, further enhance the patient’ experience by enabling data collection from home. This approach reduces the burden of frequent site visits while allowing for continuous monitoring, resulting in more accurate and comprehensive datasets.

As these technologies become more prevalent, addressing privacy and ethical concerns remains a top priority. Tools like eConsent ensure patients are fully informed about how their data will be used and protected, fostering trust in the trial process. Compliance with stringent privacy standards, such as the U.S. Health Insurance Portability and Accountability Act (HIPAA) and the FDA’s regulation regarding Electronic Records; Electronic Signatures (21 CFR Part 11), ensures sensitive health data is safeguarded. Ethical practices, including data usage transparency and patient autonomy, are integral to ensuring patient confidence in these technologies.

We recognize patient-centricity is key to any successful clinical trial. By focusing on end-user experience and addressing privacy and ethical considerations, digital technologies are increasingly seen as enablers of convenience, reduced travel burdens, and a more patient-friendly approach. This growing acceptance leads to higher compliance, better retention, and ultimately more successful trials.


Trembley: We see positive technology adoption on the clinician side, especially when the toolsets help reduce administrative burden, streamline workflows, and allow clinical teams to place a greater focus on patient care. For instance, EDC and direct data capture systems simplify data collection and minimize transcription errors, making trial participation less time-consuming for site staff. These efficiencies enable faster data processing and help ensure more accurate and timely reporting of outcomes.

Sponsors benefit significantly as well, with cleaner data, faster timelines, and greater compliance at the site level, leading to more robust and reliable trial results.

However, the key to successful adoption of these technologies lies in comprehensive training and support for site staff. At Beaufort, we recognize familiarity and confidence with new systems are critical to ensuring consistent usage and seamless integration into clinical workflows. Drawing from our experience, we provide tailored training programs that address both the technical aspects of the tools and their practical application within the study’s protocols. This includes hands-on support during startup, ongoing troubleshooting, and clear communication of expectations. By fostering strong partnerships with sites and equipping clinicians with the skills they need, we ensure technology serves as a true enabler, improving trial efficiency and data quality while reducing site burden.


Trembley: Absolutely. Digital technologies play a critical role in enhancing awareness and driving recruitment for clinical trials. At Beaufort, we leverage a multi-channel, data-driven approach to effectively target potential participants and increase enrollment rates. For example, we are able to use geographic and behavioral data from sources like the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH), combined with insights from previous studies of similar indications, to identify at-risk populations. This allows us to focus our outreach efforts on those most likely to qualify and benefit from participation.

Our approach can also include the use of digital marketing platforms—social media, search engine marketing, and targeted advertisements—to deliver compelling messaging tailored to specific demographics. Additionally, partnering with patient advocacy groups and community organizations assists in reaching underserved populations, ensuring diversity and inclusivity in our recruitment efforts. This strategy not only enhances awareness but also ensures we meet enrollment goals within established timelines.

Digital tools further complement these efforts by simplifying the enrollment process for participants. By allowing individuals to review and complete consent documents remotely, we reduce barriers to participation and make the process more accessible. These technologies work together seamlessly to enhance trial visibility, attract diverse populations, and support the overall success of the study.


Dr. Karin Hughes: There is a large spectrum of digital technologies available for potential use in a clinical investigation, including digital technologies for clinical trial process management and digital medical devices for remote data acquisition (including mobile apps).

As Bill described above, digital technologies for clinical trial process management may aid in expediting the clinical trial process by facilitating faster data collection and analysis or by reducing the cost or complexity of clinical trials. These technologies may include those used for clinical trial procedures such as recruitment and enrollment, participant consent, data collection, and data management.

However, depending on the “intended use” of a digital technology, it may meet the definition of a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act. When there is a “claim” that a digital technology (e.g., through labeling) is intended to diagnose, treat, cure, or prevent a disease or condition, that digital technology meets the definition of a medical device and is therefore regulated by the FDA. The FDA’s guidance document, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” provides recommendations on and considerations for the use of DHTs to acquire data remotely from participants in clinical investigations evaluating medical products. It includes regulatory considerations and guidance on whether engagement with the FDA may be necessary or advisable prior to using such DHTs.

FDA’s guidance document on Predetermined Change Control Plans (PCCPs) for AI-Enabled Device Software applies to FDA-regulated software that meets the definition of a device as outlined in section 201(h)(1) of the FD&C Act. It provides recommendations tailored to artificial intelligence (AI)-enabled medical devices to support iterative improvements through modifications to FDA-regulated AI-enabled devices while maintaining reasonable assurance of device safety and effectiveness. Medical device manufacturers are increasingly leveraging digital technologies, including AI-enabled device software (AI-DSFs), to drive innovation, support healthcare providers, and enhance patient care. Unlike traditional medical devices, which are typically static with fixed design and functionality at the time of FDA review, AI-DSFs follow an iterative development process. These devices are designed to learn and adapt, improving their performance over time.

FDA’s medical device regulatory pathways were initially developed for static devices, requiring supplemental submissions and reviews for any functionality changes. FDA’s guidance on PCCPs for AI-Enabled Device Software addresses the dynamic nature of AI-DSFs by establishing a framework that allows manufacturers to predefine specific modifications to their software while ensuring updates are performed predictably, safely, and while maintaining regulatory compliance. PCCPs are documentation included in a marketing submission for an AI-DSF that pre-specifies what modifications will be made, how they will be assessed (validated and verified), and describes the benefits and risks of implementing the PCCP, along with a plan for risk mitigation. If approved, these plans allow modifications to an AI-DSF over time without necessitating separate submissions and FDA authorizations, potentially accelerating the AI-DSF change process and saving FDA review time.

The PCCP guidance document outlines recommendations on the types of modifications that FDA believes may be appropriate for inclusion in a PCCP for an AI-DSF, as well as the information to include in a PCCP in a marketing submission for an AI-DSF.


Dr. Hughes: When incorporating digital technologies into medical device clinical trials, we recommend sponsors ensure the digital technologies are fit-for-purpose by clearly defining how each technology will be used (e.g., primary endpoint collection, secondary outcomes, or operational support). Sponsors should consider the technical and performance specifications of the digital technology, such as accuracy, reliability, and data output compatibility, and ensure the technology aligns with key features of the study design (e.g., whether the study is centralized or decentralized; the need for real-time data transmission or passive monitoring; etc.).

We also advise sponsors to implement strategies to minimize the introduction of bias or variability and ensure consistency of use across sites and users. This can be achieved through thoughtful planning and specification of usage in their clinical trial standard operating procedures, data management/data transfer plans, risk management plan, and a safety monitoring plan, as well as through robust training and plans for technical assistance to participants or personnel during the trial. It’s equally important for sponsors to ensure their contract research organization has demonstrated expertise in selecting, validating, and operationalizing digital technologies within clinical trials.

Finally, we recommend sponsors ensure they consider applicable regulatory requirements when using digital technologies in medical device clinical trials.

Digital technologies may meet the definition of a medical device. Although such medical devices intended for use in clinical investigations are exempt from most regulatory requirements applicable to devices, the investigation must still comply with applicable requirements under the FDA’s Code of Federal Regulations (CFR) that outline the procedures and requirements for clinical research of medical devices (21 CFR part 812). In submissions to the FDA that rely on digital technologies, sponsors need to be prepared to describe the flow of data from the digital technology to a durable electronic data repository; methods for access control, including revocation of system access; methods for verification and validation to ensure the digital technology is fit for purpose; and mitigations related to data privacy risks, cybersecurity risks, and compliant processes for obtaining informed consent.


Dr. Hughes: The integration of digital technologies into medical device clinical trials is no longer optional but essential to advancing the quality, efficiency, and inclusivity of clinical research. While these technologies offer immense potential, medical device sponsors must prioritize thoughtful implementation to unlock their full benefits. This includes ensuring digital tools are fit-for-purpose, validated, and seamlessly integrated into trial workflows to minimize risks and enhance data quality.

Equally important is a patient- and clinician-centric approach to technology deployment. Addressing usability, privacy concerns, and regulatory compliance not only improves adoption but also fosters trust and engagement among trial participants and site personnel. Collaboration with experienced contract research organizations, such as Beaufort, and proactive engagement with regulatory authorities, such as the FDA, can provide critical guidance to ensure trials align with evolving standards and leverage best practices.

As digital health technologies and AI-enabled device software evolve, regulatory frameworks like the FDA’s guidance on PCCPs enable iterative improvements while maintaining safety and compliance. By embracing these frameworks and tailoring technology strategies to each study’s unique requirements, manufacturers can drive innovation, streamline operations, and ultimately improve patient outcomes.


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