|Articles|June 19, 2018

Elligo and Partners Participate in FDA led Project

Elligo Health Research, which provides a platform that brings clinical research direct to clinical health care, announced that they will be partnering with Flatiron Health and the University of Chicago in a federal project led by the FDA to develop and pilot a common data architecture.

Read the full release here.

Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.

Related to this article

A case study of how an emerging biotech moved from targeted monitoring to full clinical operations and site management across multiple studies. Credit: Stock.Adobe.com/PHOTO4U

October 12th, 2026

Flexible Clinical Operations and Site Management Across a Diversified Biotech Portfolio: An Application of Quality by Design and Risk-Based Oversight

How a phased CRO partnership built on ICH E6(R2) and E6(R3) principles supported a multi-indication biotech portfolio.

Representation gaps in clinical trials are built into protocol, eligibility, and site decisions, not just recruitment efforts. Credit: Stock.Adobe.com/KHAN VECTOR CO.

October 12th, 2026

Beyond Outreach: Structural Drivers of Representation in Clinical Trials

The second of a two-part perspective examining why clinical trial enrollment and representation outcomes are shaped long before the first patient is screened.

October 12th, 2026

What a Practical Roadmap for FDA and EMA Quality Frameworks Actually Looks Like

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, describe what operationalizing regulatory-grade quality frameworks requires—and why fit-for-purpose evidence generation is a transparency and documentation discipline, not just a data cleanliness exercise.

Manual protocol translation slows study budgets. AI-enabled automation can shorten the path to negotiations while shifting budget builders to review. Credit: Stock.Adobe.com/7IMJAGO

October 9th, 2026

Start Study Budgets Sooner With AI-Enabled Protocol Translation

AI can turn complex protocols into first-pass budget inputs, letting sponsors start budgeting sooner while budget builders shift from data entry to review.

October 9th, 2026

AI and Patient Recruitment: Can Predictive Promise Drive True Transformation?

Trialbee CEO Matt Walz explores the current impact of AI in delivering practical gains in clinical development and reflects on its future potential, where enrollment predictability may be the biggest prize of all.

October 9th, 2026

How Routine Lab Markers Can Stand In for Missing Functional Status Data

In this video interview, Carole Berini, PhD, of Ontada, explains how validated proxies for variables like ECOG performance status can recover not just sample size but the representativeness of hard-to-reach patient populations in real-world oncology studies.

Structured data, early assay validation, and broader testing access can move trial matching from retrospective to proactive. Credit: Stock.Adobe.com/wladimir1804.

October 9th, 2026

The Test Is the Ticket: Building Smarter Pathways to Clinical Trial Participation

A biomarker test now decides who enters a precision medicine trial, yet results often go unused and assays are not ready when screening opens.

October 9th, 2026

ACT Brief: RBQM Analysis Frequency, Building Trust in Oncology Data, and Rare Pediatric PRV Monetization

In today's ACT Brief, we examine proportionate analysis frequency in RBQM, how to build trust into real-world evidence foundations for cancer trials, and how rare disease developers monetize regulatory success.