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Resources

Here, you will find a collection of case studies, fact sheets, articles, and media giving you insight into how we can support you throughout the clinical development journey and empower you with knowledge along the way.

Acquiring a biologic comparator product for a US biotech company

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

Case Studies

Importing US and EU sourced comparators into China

Supporting a large pharmaceutical company facing major challenges when importing their centrally sourced comparators into China.

Case Studies

Supplying our top 10 US pharma client with local language comparator and ancillary product

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

Case Studies

Bionical Emas Regulatory Affairs: Mutual Recognition Submission Strategy

Supporting our client to expand their commercial footprint in Europe.

Case Studies

Operational Flexibility and Adaptability

The flexibility and adaptability required to successfully manage an operationally complex adaptive clinical trial.

Case Studies

Personalized Cell Therapy

The operational expertise required to successfully manage a personalized cell therapy clinical trial.

Case Studies

Global Comparator Equivalency for Phase 3 Study

Supporting our global pharma client with their sourcing strategy of a high-value oncology comparator product.

Case Studies

Bionical Emas Global Clinical Operations: Rescue Study

Rescuing a complex pivotal phase 3 study, for the treatment of patients with distributive or vasodilatory shock.

Case Studies

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

The rapid set-up of a clinical trial at two US sites in five business days.

Case Studies

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

A collaboration with US-based SME biotech client to recognize the full potential of their products, offering a significant therapeutic advantage to patients.

Case Studies

Global Oncology Phase 3 Rescue Study

Appointed to rescue a full-service, global, randomized Phase 3 oncology trial from a CRO failing to meet a biotechnology client’s expectations regarding enrollment and cost.

Case Studies

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

Provided a full-service CRO support for a Phase 2 study to evaluate the safety and efficacy of an intranasal antibody in patients with asymptomatic or mild COVID-19 in the UK.

Case Studies