9 Notable Companies Enabling Decentralized Clinical Trials

Decentralized clinical trials (DCTs) are not a recent invention, but their adoption has accelerated as logistical complexity, geographic dispersion, and patient burden have come under scrutiny. The shift began long before the pandemic, but COVID-19 created a clear breakpoint as by 2020 remote consent, home visits, and digital monitoring moved from optional to operational in many trial protocols.

Since then, the regulatory language has changed. The FDA’s 2023 guidance on DCTs formally recognized remote data collection, telehealth, and local healthcare providers as viable components of investigational studies.

Our deep dive: AI Meets Clinical Trials: Recent Policy Shifts & Companies to Watch

The Shift to Decentralized Clinical Trials

As the FDA increasingly embraces DCTs, the industry is responding by exploring new ways to conduct clinical research. Decentralized clinical trials companies are leveraging technology such as telemedicine, mobile apps, and wearables to facilitate remote data collection and monitoring. This shift is driven by the need to improve trial efficiency, reduce costs, and enhance patient accessibility. 

Pros of Decentralized Clinical Trials

1. Improved patient access and representation: DCTs allow patients from various geographic locations and backgrounds to participate, leading to more representative and inclusive trials. For example, the Apple Heart Study enrolled more than 400k participants entirely via an app, demonstrating at-scale remote recruitment (observational, not interventional).
2. Lower patient burden: Patients can participate from the comfort of their own homes, eliminating the need for frequent travel to clinical trial sites. For example, EU regulators explicitly endorse home health visits, remote monitoring/diagnostics, direct-to-patient shipment of study drugs, and eConsent as acceptable decentralized elements. 
3. Faster enrollment and retention: The convenience and flexibility of DCTs can lead to faster patient recruitment and reduced dropout rates. For example, Tufts CSDD reports “hard metrics” for DCT ROI tied to reduced cycle times, better screening/enrollment, and fewer amendments. 
4. Continuity during disruptions and multi-site reach: Continuous monitoring through digital devices enables real-time data collection and analysis, improving the overall quality of data. For example, CHIEF-HF (randomized, double-blind, fully remote) enrolled 476 heart-failure patients across 18 U.S. health systems during COVID-19 and completed follow-up using phones and mailed devices.

Cons of Decentralized Clinical Trials

1. Data security and privacy concerns: Protecting sensitive patient information and maintaining data integrity is critical, necessitating robust security measures. 
2. Technological barriers: Limited access to technology or connectivity issues can exclude certain patient populations or introduce bias in the results. Older adults and underserved groups face access and digital-literacy barriers, risking bias if not mitigated with training, device provision, and mobile nursing.
3. Regulatory challenges: As DCTs are relatively new, regulatory bodies like the FDA are still developing guidelines to ensure compliance and safety. For now, electronic systems used in DCTs must meet 21 CFR Part 11 requirements for data reliability, security, privacy, and confidentiality; live telehealth visits must still be documented in compliant systems.

Several companies have already adopted decentralized clinical trials with notable success. For example, Medable provides a DCT software platform and works with CRO partners; Thermo Fisher’s PPD clinical research business is among them and operates “Digital & Decentralized” trial services used to deploy hybrid/remote studies across therapeutic areas.

Drug candidates have also been tested or are being tested using DCTs. For instance, Pfizer's COVID-19 vaccine trials included a decentralized component, utilizing telemedicine and remote monitoring to manage a large participant pool. Pfizer also describes a “Clinical Trial Anywhere” model using remote sampling, local locations, home health, and mobile units, aimed at reducing on-site visits in ongoing and future studies.

We surveyed several relatively young companies now shaping that infrastructure, spanning from AI-assisted study builds and patient recruitment to virtual-site management and multimodal data capture.

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Trialize

Trialize is an AI-enhanced platform designed to streamline the clinical trial process. It introduces a significant paradigm shift in how study builds are managed and executed, addressing several inefficiencies inherent in traditional clinical trial methodologies.

When inputting the study protocol, Trialize's AI analyses it to extract essential information, such as visit schedules, relevant forms, eCOA scales, and even drafts initial informed consent forms (ICFs). A notable feature of Trialize is the environment in which its AI operates. The AI resides in a controlled, isolated setting, specific to the client's instance. This isolation is meant to ensure data integrity and security while allowing the AI system to evolve in sync with the client’s expanding experience and dataset.

As more studies are conducted through Trialize, the AI's ability to rapidly produce new study builds enhances, effectively learning and adapting to the organization’s specific needs and patterns. Trialize’s architecture offers an integrated solution covering all aspects of clinical trial management – from Electronic Data Capture (EDC) and Electronic Patient-Reported Outcomes (ePRO) to TeleVisits, eConsents, and Analytics.

Case study: Revolutionizing Clinical Trials: How AI and Automation Reduced Study Build Time from Months to Days

Since 2024, Trialize has pushed into interoperability with the launch of its open-source TDOM model to standardize e-clinical data exchange.

Science 37

Science 37's platform leverages mobile technology and AI to enable patients to participate in clinical trials from their homes. This reduces patient burden and improves the diversity and inclusiveness of trials. The company uses AI for analytics and patient recruitment.

Science 37 differentiates with a national Direct-to-Patient “Metasite”—a single virtual site staffed by broadly licensed investigators and a 150+ research-grade nursing team, marketed as the first and only FDA-inspected direct-to-patient site. It also runs a stand-alone patient-recruitment service that delivers site-ready, medically reviewed, fully consented referrals.

Over 2024-2025, Science 37’s Metasite showed up in large, named programs and enablement partnerships: the company served as a key enrolling site on GSK’s Phase 3 rare-disease study, reporting it nearly doubled U.S. enrollment to reach primary completion in November 2024. Then, while leading enrollment in a registrational Phase 3 asthma trial, cleared a second FDA inspection with an NAI classification in April 2025; by September 2025 it partnered with Catalent to handle direct-to-patient IMP logistics so sponsors could run at-home participation at scale. 

Founded in 2014, Science 37 raised funding and, once valued at $1 billion, was acquired by eMed in March 2024 for $38 million; it continues to operate, with latest FDA inspection milestones reported this month. The company has worked with AWS since 2023 in a multi-year effort to scale its Metasite and reports having worked alongside Sanofi, Novartis, Genentech, Janssen, Boehringer Ingelheim, and Amgen.

Deep 6 AI

Deep 6 AI is a health technology company founded in 2015, specializing in artificial intelligence (AI) solutions for decentralized clinical trials. Its platform focuses on patient recruitment, trial feasibility, and site selection by analyzing structured and unstructured real-world data from electronic health records (EHRs) and other sources. Using natural language processing (NLP) and machine learning algorithms, Deep 6 AI identifies eligible patients for clinical trials based on demographics, medical history, and diagnoses—helping researchers expedite one of the most time-consuming phases of trial execution. The system also supports feasibility analysis and site selection by mapping patient populations to investigator performance data.

In 2024, the company advanced its EMR-based screening capabilities through collaborations with Graticule and Magnolia Market Access, aimed at improving data abstraction and accelerating enrollment. In March 2025, Deep 6 AI was acquired by Tempus, expanding the latter’s clinical-trial matching network to more than 30 million patients across 750+ provider sites. The acquisition marks a notable consolidation in AI-enabled trial recruitment, embedding Deep 6’s NLP infrastructure into Tempus’s precision-medicine ecosystem.

Andaman7

Andaman7 (Belgium, founded 2014) builds a patient-mediated platform that pairs a personal health record app with modules for decentralized research, keeping medical data on the patient’s device and exchanging it peer-to-peer rather than via a central cloud. The model is framed as “security by design, privacy by default,” with use cases spanning patient–clinician data sharing and researcher access with consent.

For trials, Andaman7 markets modules for ePRO/eCOA, RWE, and QoL studies; the mobile app supports many languages and is positioned for at-home data capture. In 2024 the company released v5 with AI features for summarization, simplification, and translation; in September 2025 it highlighted new assessment tools and questionnaires embedded in the health record.

In March 2025 Andaman7 announced it was seeking $5M to fund next steps, with no subsequent close disclosed.

Aural Analytics

Aural Analytics, founded in 2015, develops speech analytics technologies used as digital biomarkers in decentralized clinical trials. The company’s platform analyzes speech patterns to monitor neurological, respiratory, and mental health conditions.

Its system applies machine learning algorithms to extract clinically relevant features such as pronunciation, fluency, and rhythm, which reflect aspects of a patient’s health and disease status. The platform supports multiple languages and device types, enabling its use across diverse trial settings.

In decentralized trial contexts, the platform facilitates remote patient monitoring, minimizing the need for in-person visits. This approach has been associated with improved participant convenience, higher enrollment and retention, and the ability to collect longitudinal speech data that can inform treatment evaluation.

Aural’s Speech Vitals ALS technology received Breakthrough Device Designation from the FDA in 2023. The software assists in monitoring ALS in adults by collecting and analyzing speech recordings, aiming to provide more effective disease management. Aural Analytics plans to pursue further applications for Speech Vitals post-regulatory clearance.

In March 2024, Linus Health acquired Aural Analytics, folding its speech analytics capabilities into a multimodal brain health and cognitive assessment platform.

Teckro

Teckro, founded in 2015 in Ireland, provides a data-driven site performance platform that centralizes protocol content, communications, and oversight for mobile access by investigators and study teams. In April 2025, Teckro added a Patient Data Return capability—now referenced across its product pages—so participants can securely view and share their study documents, with sponsors gaining real-time visibility into engagement.

Key features of the Teckro platform include mobile access to study information, real-time updates and notifications, secure communication, and the use of machine learning and AI for faster search and retrieval of approved trial content. Through the mobile app, investigators and trial staff can access protocols, eligibility criteria, and other study materials from a single interface. Real-time updates are designed to help maintain consistency across sites, while integrated communication and data visibility are intended to support better coordination and decision-making during trial conduct.

Reify Health

Reify Health (Boston, founded 2013) is the parent company of OneStudyTeam (StudyTeam software) and Care Access (decentralized trial infrastructure). StudyTeam centralizes enrollment workflows for sites and sponsors (visit scheduling, calendar integration, eSource, referral APIs); the brand architecture with Reify as parent, OneStudyTeam and Care Access as operating businesses—has been in place since 2022.

Reify pairs an enrollment software stack that links site pre-screening and sponsor oversight in a single environment (OneStudyTeam) with an on-the-ground research network that deploys community-integrated and mobile sites (Care Access). The combination is used to address bottlenecks in patient identification and recruitment while extending geographic reach and participant diversity.

Care Access entered a strategic partnership with HHS/BARDA in 2024 to enhance pandemic preparedness, and expanded in Latin America via the acquisition of Brazil’s CEMEC on March 10th, 2025; Care Access also highlighted peer-reviewed evidence of its model in Frontiers in Medicine this September: community-integrated sites achieved higher per-site screening and randomization than traditional models while maintaining comparable post-randomization retention.

The most recent disclosed financing is the $220M Series D in April 2022 at a $4.8B valuation, with that, OneStudyTeam also reduced headcount by ~25% (160 roles) by the end of the year.

Medable 

Medable provides a decentralized trial platform to reduce the time of clinical trial processes. They use digital and AI tools to speed up patient recruitment and improve patient engagement. The platform also supports remote data collection and real-time data analysis.

In June 2023 Medable and the MRCT Center launched a standardized ethics-review toolkit for decentralized trials, offering IRBs and ECs a shared framework to streamline DCT approval. From late 2024 through 2025, Medable expanded significantly: it joined the Google Cloud Marketplace, launched Medable AI/Studio, rolled out oncology and long-term follow-up modules for cell and gene therapies, reported ~80% 2024 revenue growth fueled by broader eCOA use, and introduced a CRO Partner Program and “Agent Studio” (AI-assistant for CRAs). It also gained CNIL approval (with Servier) for its eConsent/eCOA tools.

Read also our interview with Medable Co-Founder and CTO Tim Smith about how the company is rethinking clinical trials through its no‑code platform and data‑driven approach.

Medable raised a Series D of $304M on Oct 26, 2021 (co-led by Blackstone Growth and Tiger Global), bringing total funding to ~$521M at a $2.1B valuation.

THREAD

THREAD offers a no-code, configurable DCT/eCOA platform used in 60+ countries, pairing virtual visits, eConsent, wearables, and a large instrument library with endpoint-science services and inVibe patient-listening capability.

Since 2023 the company has listed its solutions in AWS Marketplace, and in 2025 it rolled out a major platform release and a Bedrock integration that uses LLMs to summarize patient-voice data from inVibe. Recent deployments include Allucent’s BARDA-backed decentralized program and a self-service studies launch with University of Pittsburgh CTSI; a five-year global DCT/eCOA collaboration with Sanofi was announced in 2023.

Topic: AI in Bio