Niche supported ReCode Therapeutics in launching their first UK patient study, delivering end-to-end clinical and regulatory operations for...
Clinical Operations
Clinical Project ManagementStudy Monitoring and Site ManagementTrial Master File and Document ManagementQuality and Vendor Management SystemsStudy DocumentsRegulatory Affairs
Regulatory StrategyRegulatory WritingAgency Communications and SubmissionsDocument Editorial, QC and SubmissionQC, Review and RedactionLegal RepresentationPharmacovigilanceILAP SubmissionsMedical Communications
Publication PlanningStrategic CommunicationsScientific CommunicationsMedical EducationMedical IllustrationGrant Applications and Project PartnershipNiche supported ReCode Therapeutics in launching their first UK patient study, delivering end-to-end clinical and regulatory operations for...
Trusted as Legal Representative and on-the-ground CRO, Niche became integral to Surface Logix's EU clinical team, delivering four trials...
Chosen as FDL's UK regulatory and clinical operations partner, Niche managed three Phase 1a/b cystic fibrosis studies from MHRA submission...
Embedded in HMR's early-phase work since 2005, Niche has supported their specialist Phase I and II trials with monitoring, CTA submissions,...
Brought in from the very first CTA submission, Niche grew into Pulmocide's fully embedded clinical and regulatory partner, covering...
Niche functioned as RespiVert's extended clinical and writing team across multiple early-phase respiratory programmes, contributing to the...