Europe, Government/Regulatory, Industry News, International

MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions

1. Scope This document provides an introduction to the MHRA’s real-world data (RWD) guideline series, and points to consider when evaluating whether a RWD source is of sufficient quality for the intended use. Sponsors interested in the use of RWD in their development programmes are encouraged to engage with the MHRA for further…

Europe, Government/Regulatory, Industry News, International

MHRA guideline on randomised controlled trials using real-world data to support regulatory decisions

1. Overview This guideline is aimed at sponsors who are planning to conduct a randomised, controlled clinical trial primarily using real-world data (RWD) sources to support a regulatory decision relating to a medicinal product. This is one of a planned series of guidelines on the use of RWD for supporting regulatory…

Competitor News, M&A

Protocol First Joins Flatiron Health

NEW YORK and SALT LAKE CITY, Dec. 16, 2021 /PRNewswire/ — Protocol First, a software solutions provider focused on accelerating clinical research, will become a wholly owned subsidiary of Flatiron HealthⓇ, the two companies announced today. “This is a win-win for both companies,” said Carolyn Starrett, Flatiron CEO. “Flatiron and Protocol First share a common…

Competitor News, Product Updates

Ciox Health’s Data Utilities boost clinical data accuracy, insight, and value derived from chart retrievals

ALPHARETTA, Ga., Dec. 15, 2021 /PRNewswire/ — Ciox Health™, a leading health technology company, today announced the release of Ciox Data Utilities™. Ciox Data Utilities is a suite of solutions designed to add value to digital clinical chart retrievals. The suite is offered either stand-alone or as a bundle with Ciox Digital Direct, the…

Collaborations, Competitor News

Snabb Partners with Health Gorilla to Establish One of the First National Laboratory Networks in Chile

Palo Alto, California, Dec. 15, 2021 (GLOBE NEWSWIRE) — Health Gorilla, the leading provider of interoperability solutions in Latin America, and Snabb, Chile’s most prominent healthcare scheduling platform, have partnered to create one of Chile’s first national laboratory networks.  Snabb has built clinical partnerships with a variety of providers in…

Competitor News, COVID-19, RWE Study

nference and Mayo Clinic Study Confirms Effectiveness of Moderna and Pfizer/BioNTech Vaccines Against COVID-19 Alpha and Delta Variants

CAMBRIDGE, Mass., Dec. 15, 2021 /PRNewswire/ — nference, the AI-driven health technology company, announced today publication of a peer-reviewed study in Med that analyzed Mayo Clinic based data with nference artificial intelligence (AI) software to determine that both the Moderna and Pfizer/BioNTech vaccines were over 70% effective at preventing symptomatic COVID-19 between December 2020 and September 2021, including…

Collaborations, Competitor News, Data Partnership, Oncology

Bayhealth Collaborates with Syapse, Bringing Data-Driven Approach to Oncology Care

SAN FRANCISCO and DOVER, Del., Dec. 15, 2021 (GLOBE NEWSWIRE) — Syapse®, a leading real-world evidence company dedicated to extinguishing the fear and burden of serious diseases by advancing real-world care, announced a collaboration with Bayhealth, central and southern Delaware’s healthcare leader. Bayhealth will utilize the Syapse multi-source real-world data platform to…

Collaborations, Competitor News, Data Partnership, Oncology, Pharma, RWE Study

New Clinical and Real-World Data Support Use of DARZALEX®▼ (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma

December 11, 2021 09:35 AM Eastern Standard Time BEERSE, Belgium–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new analyses illustrating responses that first-line treatment with DARZALEX®▼ (daratumumab)-based regimens may be able to achieve, including a potential survival benefit for daratumumab in combination with lenalidomide and dexamethasone (Rd).1,2 Updated…

AI, Competitor News, Fundraising/IPO

Lynx MD Raises $12 Million Seed Funding to Reinvent Healthcare Data Collaboration

Lynx’s cutting edge platform and anonymization technology leverages over 200 million historical data points spanning over two decades to help healthcare organizations facilitate secure data sharing and optimize outcomes Lynx MD, the leading healthcare AI platform for real world clinical and operational data collaboration, today announced it has raised $12…