With 37 Diversity Action Plans supported to date, Fortrea Regulatory Strategy Consulting is closely tracking the latest FDA draft guidance on Diversity Action Plans. Learn about our ongoing efforts to meaningfully improve the diversity of clinical trial participants in global studies: https://lnkd.in/e47ZtePa #diversityinclinicaltrials #diversityequityandinclusion #diversityinhealthcare #healthequity #advancinghealthequity #clinicaltrials #clinicalresearch
Fortrea’s Post
More Relevant Posts
-
We provide comprehensive and top-notch services to meet your clinical trial's requirements. We also offer solutions to the real-time challenges sponsors and CROs encounter in clinical trials. Our highly skilled team of researchers conducts clinical trials while adhering to quality standards set by the FDA, Institutional Review Boards, and other regulatory bodies. #ServiceForChange #InnovativeSolutions #sustainabilitygoals #climateaction #clinicaltrials #MRS #MinervaResearchSolutions
-
-
While a lot has changed in the past five years in clinical research, reasons for findings on FDA inspection have remained fairly constant. Issues such as protocol non-compliance, incomplete case history documentation, and inadequate investigational drug disposition records are the most frequently cited items year after year. Implementing clinical trial technology at the site level can detect and potentially avoid frequently observed quality issues arising during the trial. So how can sponsors and CROs help support sites in using their own technology? Swipe through for five ways to work with technology-enabled sites. Read the full article co-authored by me and my colleague Kate Yawman: https://lnkd.in/eZVz_9fd #clinicaltrials #clinicalresearch #healthcareinnovation Advarra
-
Our team leverages extensive experience to optimize protocol design, drawing insights from successful and unsuccessful trials. We understand what works and what doesn't, enhancing efficiency and mitigating resistance from regulatory authorities like the FDA. Learn more about True North here, https://truenorthcro.com/ #OphthalmologyInsights #ClinicalTrialsSuccess #ClinicalResearch #ClinicalTrials FDA True North Contract Research Keeley Puls-Boever
-
Be sure to join our team for this upcoming #rapsconvergence webinar on September 14th! Gain insight and understand the upcoming critical changes for #ema Policy 0070 #certara #synchrogenix
Join Certara & Regulatory Affairs Professionals Society (RAPS) on September 14 for a joint webinar to learn about critical changes to #EMA Policy 0070 and expert tips on aligning with regulatory expectations. Register at https://ow.ly/PnLF50PFuh5 #Pharma #RegulatoryAffairs
-
The latest CDE guideline offers advice on platform validation for viral clearance, with an approach that is consistent with the requirements of the ICH guideline Q5A(R2) and the region-specific guidance from the EMA and FDA. Find out more in our latest blog in the Regulatory Navigator series.
New China CDE guidance on platform validation of viral clearance aligns with FDA and EMA :: Parexel
share.parexel.social
-
Join Certara & Regulatory Affairs Professionals Society (RAPS) on September 14 for a joint webinar to learn about critical changes to #EMA Policy 0070 and expert tips on aligning with regulatory expectations. Register at https://ow.ly/PnLF50PFuh5 #Pharma #RegulatoryAffairs
Sponsored Webcast: How to Plan for a Successful EMA Policy 0070 Submission
raps.org
-
The #FDA has issued final guidance that reflects its current thinking and recommendations regarding #informedconsent and describes FDA regulatory requirements to help protect those in clinical #investigations. Learn more about what the guidance entails in our latest On the Subject. Authors: Jennifer Geetter, Anisa Mohanty and Sam Siegfried
FDA Issues Final Guidance on Informed Consent in Clinical Investigations
mcdermott.shp.so
-
The latest CDE guideline offers advice on platform validation for viral clearance, with an approach that is consistent with the requirements of the ICH guideline Q5A(R2) and the region-specific guidance from the EMA and FDA. Find out more in our latest blog in the Regulatory Navigator series.
New China CDE guidance on platform validation of viral clearance aligns with FDA and EMA :: Parexel
share.parexel.social
-
The latest CDE guideline offers advice on platform validation for viral clearance, with an approach that is consistent with the requirements of the ICH guideline Q5A(R2) and the region-specific guidance from the EMA and FDA. Find out more in our latest blog in the Regulatory Navigator series.
New China CDE guidance on platform validation of viral clearance aligns with FDA and EMA :: Parexel
share.parexel.social
Brand storyteller, content crafter, and all things social
3w🎉!