Project management: UK Biotech

Project Management UK Biotech Delivering a Phase II European StudySupporting with Senior Project Manager The ChallengeAptus Clinical was approached by a UK Biotech to supply a Senior Project Manager to oversee a Phase II Europe wide study being delivered by a major CRO The SolutionA highly-qualified Project Manager was recruited for this role by Aptus...

Clinical operations team: AstraZeneca

Clinical Operations Team AstraZeneca Delivering Global StudyPhase IIb BEECH The ChallengeAptus Clinical were asked by AstraZeneca (AZ) to provide a clinical operations team to deliver their global Phase IIb BEECH study in 11 countries The SolutionAptus Clinical efficiently supplied five highly experienced and skilled clinical operations professionals to undertake this work The OutcomeWorking with AZ...

Due diligence report for investment: UK Biotech

Due diligence report for investment UK Biotech Completing Due DiligencePrior to Making an Investment Decision The ChallengeAptus Clinical was approached by a venture capital company to perform due diligence on a UK Biotech prior to making an investment decision The SolutionAn expert panel was rapidly convened to evaluate the data and produce a comprehensive report....

A Phase I Study in Niemann Pick: CTD Holdings

A Phase I Study in Niemann Pick CTD Holdings Support the Development ofTRAPPSOL® CYCLO® The ChallengeAptus Clinical was asked by Cyclo Therapeutics to join their International Program Team to support the development of TRAPPSOL® CYCLO® for the treatment of Niemann Pick type C (NPC-1).  Aptus was contracted to support the global delivery of a their Phase I/II, randomised, double-blind trial with sites in the UK, Israel and...

Phase II uveal melanoma study: UK Biotech

Phase II Uveal Melanoma Study UK Biotech Supporting a Phase II studyWith Novel Immuno-oncology Agent The ChallengeAptus Clinical was asked to support the EU delivery of a Phase II uveal melanoma study with a novel immuno-oncology agent The Solution An Aptus Clinical study team was established to support the identification, set-up and monitoring of UK sites ​ Selection of high performing sites, building on existing...

Design of innovative FiH study: CellCentric

Design of Innovative FiH Study CellCentric Planning a Route ForwardPlanning a First in Human (FiH) study The ChallengeCellCentric approached Aptus Clinical to assist them in designing their First in Human (FiH) study for their lead project, a small molecule inhibitor of p300/CBP The SolutionAptus Clinical convened a multi-disciplinary panel of medical, scientific and technical experts...

Development of an operationally feasible clinical pharmacology package

Development of an operationally feasible clinical pharmacology package US Biotech Case Study Development of Pharmacology Programme For Lead Oncology Asset The ChallengeAptus Clinical was asked by a US-based Biotech to assess whether the clinical pharmacology programme for their lead oncology asset could be conducted in healthy volunteers rather than patients The SolutionAn expert panel was...

Development of Clinical Quality Management Systems: Istesso

Development of Clinical Quality Management Systems Istesso Case Study Planning a Route ForwardPlanning a First in Human (FiH) study The ChallengeIstesso (formerly Modern Biosciences) approached Aptus Clinical to review and update their standard operating procedures (SOP) prior to undertaking the First in Human (FiH) study for their lead project The SolutionAptus Clinical identified a clinical...

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