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UK trial regulation may support haemophilia treatment access

The new MHRA scheme helps to reduce the time it takes for the lowest-risk clinical trials to commence, while maintaining patient safety.

United kingdomAndrea manfrinRegulatory agencyResearch application systemNotification schemeClinical trial authorisationsClinical investigationsIntegrated research application system

New FDA Draft Guidance Data Integrity For In Vivo Bioavailability And Bioequivalence Studies

New FDA Draft Guidance Data Integrity For In Vivo Bioavailability And Bioequivalence Studies
clinicalleader.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from clinicalleader.com Daily Mail and Mail on Sunday newspapers.

Qc program for data integrityQa programPrinciples of software validationHealthcare ltdClear lines of authoritySaddam nawazData integrityVivo bioavailabilityQualified testing sitesTesting sitesMonitoring planIdentifying deviationsData flowComputerized systemsLevel assessmentControl measures

Study Identifies New Predictor of Severe Pediatric Crohn's Disease

Study Identifies New Predictor of Severe Pediatric Crohn's Disease
cornellsun.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from cornellsun.com Daily Mail and Mail on Sunday newspapers.

Alexxandria shumwayKiran kadakiaPraveen sethupathyUniversity of north carolina at chapel hillClinical investigationsNorth carolina

Transforming clinical trials

The UK has remodelled its ecosystem for clinical trials to create a world-leading landscape for life sciences research and development

United kingdomOxfordshireMelanie ivarssonJames oshaughnessyAndrea manfrinRegulatory agencyNational health serviceJameso shaughnessyUnited kingdom governmentUnited kingdom basedChief development officerDeputy directorClinical investigationsNew scientist

FDA Finalizes Guidance On DHTs For Remote Data Acquisition - Healthcare

New guidance provides recommendations to ensure digital health technologies are fit-for-purpose for collecting high-quality clinical data to evaluate medical products.

Digital health technologiesDrug administrationHealth technologiesRemote data acquisitionClinical investigationsMondaqFda finalizes guidance on dhts for remote data acquisitionFoodDrugsHealthcareLife sciencesFood and drugs lawHealthcare