News from the healthcare data industry
VANCOUVER, BC, Jan. 4, 2022 /CNW/ – On the 17th December 2021 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) produced guidance acknowledging and setting out the criteria for the use of Real...
By Tamra Sami PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has undertaken a massive effort to reform its drug and device regulations, and as it pulls into the homestretch with those reforms,...
31 Dec 2021 NEWS Â Vibha Sharma Executive Summary The UK Medicines and Healthcare products Regulatory Agency has finalized the first part of a series of new guidance documents addressing issues...
The companies will reportedly focus on exploring real-world evidence and conducting clinical trials through G42 Healthcare’s Contract Research Organisation, IROS.By Rachel McArthurDecember 24, 202108:37 AM Credit: iStock AstraZeneca has teamed...
By Mark McCarty The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has unveiled two guidances for the use of real-world evidence (RWE) in regulatory decision-making. The policy seems limited to pharmaceutical clinical...
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...
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...
STATION F is excited to welcome Palantir Technologies as a partner of the Foster the Future initiative, which will offer workshops and conferences to early-stage companies and allow them to...
MENLO PARK, Calif. and SINGAPORE, Dec. 06, 2021 (GLOBE NEWSWIRE) — ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today...
SAN FRANCISCO, Dec. 06, 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, presented five abstracts...