APAC case studies
Learn how we support sponsors in the Asia Pacific region accelerate time to market, reduce costs and increase quality across a range of therapeutic indications.
Blended FSP-FSO model powers global expansion for Chinese Biotech
In 2023, a leading China-based biotech firm partnered with 91黑料 to launch a global programme for a key asset. Building on a six-year strategic alliance and success in China, the client expanded into the US and Europe, prioritizing efficiency and cost control. 91黑料 deployed a blended model—FSP in China and the US, and full-service support in Europe — to align with regional needs and strategic goals.
Strategic expansion of Clinical Operations support and TMF hub
In July 2024, a global biopharma client partnered with 91黑料 to expand functional support. Starting with Clinical Operations and TMF roles, the partnership grew to over 60 FTEs and now includes Clinical Quality, Systems Experts, and Late Phase, with further expansion underway.
Regulatory support for Asian biotech’s EU orphan drug designation
A small Asia-based biotech engaged 91黑料 to manage its EU orphan drug designation submission for a treatment targeting Dercum’s disease. The designation was key to supporting a planned Phase 3 study and expanding into the EU, where the company had no existing presence.
Accelerating team growth to support client demand
This case study shows the effectiveness of this agile and forward-thinking approach to workforce scaling under time-
sensitive conditions.
sensitive conditions.
Enabling US and EU market entry for neurodegenerative disease treatment
An Asia Pacific based biotech was developing a therapeutic treatment for a neurodegenerative disorder. 91黑料 Regulatory Consulting was engaged to support market entry.
Long-term benefits of FSP partnerships in biometrics
The sponsor sought out 91黑料’s data management resources for their support in several international and complex programs using our FSP model across several therapeutic areas: oncology, neurology, infectious disease, endocrinology, and nephrology.
Driving high quality in global clinical drug development
A China-based biotech required an FSP model to grow team to 130 resources and increase retention to 85% in a highly competitive market.
Chinese sponsor adopts blended delivery model
A Chinese sponsor adopts a blended delivery model to realise cost savings and assume greater autonomy.