Case Studies

Case studies

Bionical Emas Regulatory Affairs: Mutual Recognition Submission Strategy

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Effective Pharmacovigilance & Regulatory EU and Australian Due Diligence, leading to operational and consultative support

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From kick-off meeting to SIV in five days – a severe COVID-19 pneumonia case-study

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Global Comparator Equivalency for Phase 3 Study

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Global Oncology Phase 3 Rescue Study

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Operational Flexibility and Adaptability

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Locally sourcing, storing and distributing comparators and ancillaries for a global phase 3 study

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Operational Considerations for Designing and Setting up a Site-less Decentralised Clinical Trial (DCT)

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Personalized Cell Therapy

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Bionical Emas Global Clinical Operations: Rescue Study

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Delivering savings, sustainability and expedited timelines through our UniQ™ supply process

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Case Studies

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European EAP with tailored RWD strategy

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Global EAP for a specialized biotech company

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Global Early Access Program Takeover

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Guide the evolution of a pre-approval access policy for gene therapy (DMD)

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Operationalise an EAP for a rare neurodegenerative condition (ALS)

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Operational Considerations for Designing and Setting up a Site-less Decentralised Clinical Trial (DCT)

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