IBB Consulting ApS

"Together with you, I will build your nonclinical safety program and find solutions when you meet challenges"

      Non-clinical Safety Plans:​

• Design of non-clinical safety plans for NCEs and NBEs at all stages
• Early toxicology exploration - de-risking

• First human dose enabling animal studies
• Phase II and III supporting non-clinical packages
• Pivotal studies for Marketing Applications
• Considerations of target biology, formulation, dosing regimen in clinical trials etc.
• Animal species qualification strategy for safety studies
• In vitro and in vivo safety models
• General and genetic toxicology studies
• Safety pharmacology studies
• Expert knowledge in reproductive, developmental and juvenile toxicology study conduct and evaluation
• Carcinogenicity studies
• Assessment of phototoxicity
• Non-clinical input to Paediatric Plans (PIPs)
• Support to due diligence

Dr. Ingrid Brück Bøgh

Regulatory and scientific documents

• Writing and review of non-clinical sections for CTD-module 2, preIND packages, INDs, IBs, DSUR/PSUR, PIPs, Marketing applications (BLA/NDA)
  
• Non-clinical Risk Profiles
• Safety evaluation prior to Clinical Trial Applications
  
• Preparations and participation in Scientific Advice meetings
• Scientific strategy for internal company communication
• Writing of scientific publications for internationally peer reviewed journals

Study conduct and CRO outsourcing

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• CRO study placement, if desired quotes from several CROs can be requested
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Sponsor's monitor role

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• Detailed study design
• Protocol writing
• Dose setting
• In life monitoring
• Report review and finalisatoin
• Interpretation of results
• Overall toxicological evaluation and risk assessment
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Educational sessions

• The role of non-clinical safety within the drug development value chain
• Toxicology in drug development
• Species and strain selection
• Dose selection in tox studies
• Dose setting for First in Human trials
• Guideline requirements
• Reproductive developmental assessment
• Juvenile toxicology studies
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