Clinical research sites are speaking up.
The average site now juggles 22 different technology systems per study, each with its own logins, training, and data pipelines. That kind of overload leads to staff burnout, compliance risk, and redundant workflows that drain time and quality.
But what if the solution isn’t more technology? What if it’s trusting sites to use the technology they already know best?
That’s the premise behind the Bring Your Own Technology (BYOT) initiative, led by Decentralized Trials and Research Alliance (DTRA) and co-authored by RealTime’s Founder and Chief Strategy Officer, Rick Greenfield, alongside global technology and operations leaders from GSK, Medable, Syneos Health, Bristol Myers Squibb, Medidata, Eli Lilly, and Mayo Clinic.
The new BYOT Playbook offers a blueprint for empowering sites to use their validated systems — like eSource, eReg/eISF, and eConsent — within sponsor-funded clinical trials without compromising sponsor oversight or data quality.
Rethinking Technology Ownership in Clinical Trials
For decades, trial technology has flowed in one direction — from sponsors down to sites. While this model offered control and standardization, it came at a steep cost: redundant systems, re-training on every new study, and diminished efficiency.
BYOT flips the model. It proposes a hybrid approach where sites can use their existing validated systems, and sponsors can still rely on central data pipelines through interoperability standards such as CDISC ODM, USDM, and FHIR.
Amid the site consolidation movement and the rapid growth of site-led technology, sites are no longer just endpoints for data. Modern, tec-enabled sites are emerging as active partners with the infrastructure and insight to drive quality, speed, and compliance.
The Compliance Dossier: A New Currency of Trust
One of the BYOT Playbook’s most powerful innovations is the Compliance Dossier, a standardized digital package that sites can maintain and share with sponsors. Think of it as a “Trust Passport” for site technology. Each dossier includes:
- System architecture and hosting details
- Information security protocols (encryption, access control, privacy compliance)
- Validation evidence (plans, test results, change logs)
- Audit trail and eSignature functionality
- Proof of adherence to FDA 21 CFR Part 11, ICH E6(R3), and GDPR
This dossier replaces the need for sponsors to “revalidate” the same system at every new study. Instead, a centralized validation record, housed in a vendor “Trust Center” or consortium-managed portal, offers reusable, inspection-ready documentation.
The result? Less redundancy, faster study startup, and stronger sponsor confidence in site systems.
From eConsent to eSource: The Horizons of BYOT
The BYOT Playbook outlines a phased model of adoption:
Horizon 1 – eConsent:
The most accessible entry point. Sponsors approve sites’ validated eConsent platforms, addressing one of the top FDA inspection findings while improving participant understanding and engagement.
Horizon 2 – eSource, eISF, and DDC:
Future phases expand BYOT to include full source data, regulatory binders, and direct data capture, all connected through industry data exchange standards.
By starting with eConsent and scaling up, BYOT offers a pragmatic path to interoperability versus a disruptive overhaul.
Regulatory Readiness Meets Operational Freedom
The BYOT Playbook doesn’t shy away from tough questions around oversight and compliance. It emphasizes that sponsors remain accountable for data quality and participant safety, while sites bear responsibility for maintaining validated systems, change control, and audit readiness.
Importantly, regulators are already moving in this direction:
- The FDA’s guidance on Electronic Systems, Records, and Signatures endorses risk-based validation and flexibility.
- The ICH E6(R3) guidance supports proportional oversight and innovation when aligned with GCP principles.
BYOT bridges these regulatory evolutions with a practical framework grounded in documentation, audit trails, and shared accountability.
A Real-World Case for BYOT
The BYOT model isn’t theoretical. Sites, AMCs, and health systems leveraging RealTime’s validated eClinical systems within a unified Site Operations Management System (SOMS) have already demonstrated the core outcomes BYOT was designed to deliver:
- Screening timelines reduced from 7+ days to same-day contact
- 98% faster time-to-first follow-up
- Higher participant retention through integrated, familiar tools
These outcomes prove that when sites use technology they trust, data moves faster, cleaner, and more compliantly. A win for both sponsors and patients.
The Road Ahead
BYOT isn’t an “all or nothing” revolution. As sites, sponsors, and regulators align around shared standards, the industry can finally move from disconnected silos to a truly interoperable clinical ecosystem.
For sponsors, it means accelerating trials without sacrificing oversight. For sites, it means reclaiming efficiency and autonomy. For participants, it means better experiences and faster access to care.
Advancing clinical research doesn’t rest on adding more systems. It depends on trusting the systems that already work.
The industry is shifting towards a model we’ve always championed. Download the BYOT playbook from DTRA to explore the framework in full: Bring Your Own Technology (BYOT) Playbook
Read More: RealTime Reports: eSource ROI Survey Summary
Read More: CTMS vs SOMS – Why Your site Needs a Unified eClinical Toolkit
FAQ: Bring Your Own Technology (BYOT) in Clinical Trials
Q: What does “Bring Your Own Technology” mean in clinical trials?
A: Bring Your Own Technology (BYOT) is a model that allows clinical research sites to use their own validated eClinical systems, such as eSource, eReg/eISF, and eConsent, within sponsor-funded clinical trials. Instead of being forced to use sponsor-provided tools, sites operate in platforms they already know, while sponsors maintain oversight and data integrity through interoperability standards.
Q: Why is BYOT important for sites, AMCs, and health systems?
A: Most sites now manage an average of 22 different systems per study, which increases administrative burden, staff fatigue, and compliance risk. BYOT simplifies this by letting sites work in familiar systems, cutting redundancy and reducing training time. For AMCs and health systems, it means improved efficiency and visibility across all studies.
Q: How does BYOT help sponsors and CROs?
A: Sponsors benefit from cleaner, faster, and more compliant data without disrupting site workflows. Through interoperability frameworks like CDISC ODM, USDM, and FHIR, sponsor systems can still receive standardized data directly from site systems.
Q: What is the BYOT Playbook?
A: The BYOT Playbook, published by the Decentralized Trials & Research Alliance (DTRA), serves as a roadmap for implementing BYOT in sponsor-funded trials. It was co-authored by leaders from RealTime eClinical Solutions, GSK, Dauntless, Medable, Syneos Health, Medidata, Bristol Myers Squibb, Eli Lilly, and Mayo Clinic. The Playbook explains how to align technology validation, data standards, and oversight responsibilities between sponsors and sites.
Q: How does BYOT ensure compliance with FDA and ICH guidelines?
A: BYOT aligns with both the FDA’s Electronic Systems, Records, and Signatures guidance, which promotes risk-based validation, and the ICH E6(R3) update, which supports proportional oversight and flexibility under Good Clinical Practice (GCP). It balances innovation with accountability through audit trails, documentation, and validation controls.
Q: What is the Compliance Dossier mentioned in the BYOT Playbook?
A: The Compliance Dossier is a standardized digital record that acts as a “Trust Passport” for site technology. It includes system validation evidence, data-security protocols, audit trails, and regulatory documentation. Sponsors can review this dossier instead of re-validating the same system for every study. This reduces redundancy and accelerates study start-up.
Q: How does RealTime’s SOMS platform fit into BYOT?
A: SOMS (Site Operations Management System) by RealTime provides the operational foundation for BYOT. It connects eSource, eReg/eISF, and participant-engagement tools into one unified command center, giving AMCs and health systems full visibility, performance tracking, and compliance oversight. SOMS proves how site-led, validated systems can deliver faster data and stronger sponsor partnerships.
Q: What real-world results have sites achieved with BYOT and SOMS?
A: Organizations using RealTime’s validated eClinical systems within SOMS have achieved:
- Screening timelines reduced from 7+ days to same-day contact
- 98% faster time-to-first follow-up
- Higher participant retention through familiar, integrated tools
These results validate the efficiency and compliance advantages of the BYOT model.
Q: Is BYOT only for eConsent systems?
A: No. While eConsent is the most common entry point (known as Horizon 1 in the Playbook), future horizons include eSource, eISF, and Direct Data Capture (DDC). This phased approach helps sponsors and sites adopt BYOT gradually without disrupting ongoing studies.
Q: How can my site or institution get started with BYOT?
A: Begin by reviewing your validated systems and assembling a Compliance Dossier for sponsor review. You can download the BYOT Playbook from the DTRA website to explore step-by-step guidance. For institutions using RealTime, SOMS already provides the interoperability and documentation structure needed to operationalize BYOT quickly and compliantly.
Q: Where can I learn more about BYOT and site-led technology?
A: Visit RealTime eClinical Solutions to explore resources on SOMS, eSource, and interoperability, or download the BYOT Playbook from the Decentralized Trials & Research Alliance (DTRA) to learn how this framework is redefining technology ownership in clinical research.