Decentralized Clinical Trials

Global clinical development has evolved into a technology-enabled, highly regulated, and geographically diversified enterprise, as sponsors adapt trial design, partnerships, and operations to meet rising demands for scale, speed, and patient-centricity.

New survey data show a strong patient preference for fully remote clinical trials, underscoring how convenience, intuitive technology, and FDA-cleared digital tools are reshaping enrollment and retention strategies as decentralized models become a lasting fixture in clinical research.

A new global Tufts CSDD survey of 387 investigative site professionals reveals broad experience with digital and decentralized trial tools, growing site-driven technology investments, and strong support for remote data collection—while highlighting persistent burdens tied to fragmented systems, training demands, and financial strain.

As decentralized and hybrid trial models expand, eConsent is emerging as a critical tool for improving participant understanding, reducing site burden, and strengthening data integrity through digital automation, accessibility, and regulatory compliance.

Interviews with biopharma leaders and outsourcing partners reveal emerging trends in clinical trial resourcing models, highlighting a shift away from traditional full-service CRO arrangements toward hybrid strategies that balance in-house expertise, trusted consultants, and selective outsourcing.

A unified technology approach improves study efficiency and data collection.

As clinical research increasingly relies on RWD to enhance trial design and patient insights, tokenization has emerged as a critical solution for securely linking disparate datasets while protecting patient privacy.

In this Q&A, Megan Bailey, EVP and president of central laboratories and international, Labcorp, discusses how central labs are evolving beyond testing to become strategic partners in clinical trial success.

Andrew Mackinnon, Executive GM, Medable, discusses how AI-driven innovations are streamlining clinical trials through enabling scalable operations.

In this video interview, Cameron Breze, product manager, Inovalon, highlights current trends with decentralization and how a dual approach can ensure flexibility across different therapeutic areas.

Addressing data integrity and compliance concerns.

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Pamela Tenaerts, chief scientific officer, Medable, discusses the need for more data around the implementation of clinical technology.

Progress made in measuring decentralized clinical trial use in patient recruitment and retention.

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Tenaerts, chief scientific officer, Medable, highlights the recent findings and how decentralized elements can improve access to underrepresented populations.

Research from the Tufts Center for the Study of Drug Development’s PACT Consortium shows DCTs encourage higher participation across multiple demographic groups.

Use of decentralized approach in a Phase 1 pharmacokinetic trial shows the ability to enable remote data collection and monitoring, which could improve patient access and enhance the efficiency of clinical research.

Compliance with state telemedicine requirements is imperative, as not only will most clinical trial sponsors contractually require such compliance, but non-compliance may also subject the practitioner to licensure violations and liability.