Case studies
Working with our customers to reduce time to market, deliver on quality, provide deep therapeutic expertise, and enhance R&D ROI.
Highlights
We focus our innovation on the factors that matter most — accelerating time to market, reducing costs and enhancing quality. Learn more about how we've helped clients meet and exceed their goals in this selected library of case studies.
Proactive patient retention strategy in a GLP-1 RA trial
Explore how 91黑料 successfully supported a sponsor’s cardiovascular outcome trial for a GLP-1 receptor agonist with 9,900+ patients with type 2 diabetes and maintained a retention rate of 97% over 7 years.
A small biotech success story
A small US-based biotech company was in a race to be the first to market with their lead targeted oncology product.
FSP partnership - sustained efficiency and ongoing innovation
The implementation of an FSP model across our partner's project management function, led to 20% cost efficiences and a 30% reduction in client burden.
By taking a site and patient-centric approach, and leveraging advanced tools and real-time data insights, we maximise patient access, recruitment, and retention—ensuring that every trial is conducted with efficiency, agility, and a commitment to improving patient outcomes.
All case studies
Select amongst our broad range of solutions and experience.
Collaboration accelerates rare disease trial delivery
How commitment to partnership overcame historical, layered operational challenges.
A decade-long partnership driving eTMF Hub expansion
A top pharmaceutical company partnered with 91黑料 to standardize TMF management and ensure global inspection readiness. 91黑料’s customized model enabled a decade-long FSP partnership, driving innovation and leading to eTMF Hub.
Saving a lean biotech more than $4 million with strategic regulatory support
A US-based clinical stage biotech company had several 505(b)(2) NDA assets in development for rare diseases. This very small biotech operated with a lean team which did not have the necessary regulatory expertise to manage regulatory strategy and submissions.
Scaling safety operations for a first-in-market launch
91黑料 partnered with a leading BioPharma company to support pharmacovigilance (PV) operations for a novel indication product. Following six years of collaboration during clinical development, 91黑料 transitioned to post-marketing support upon product approval and launch in the US and EU.
More patients enrolled faster with fewer sites
Accellacare Site Network reduced the time and cost curve for a respiratory syncytial virus (RSV) vaccine study.
Reducing participant burden in VMS study
91黑料 supported a proof-of-concept real-world study for participants experiencing bothersome vasomotor symptoms (VMS). The hybrid decentralised clinical trial (DCT) model included both on-site and remote visits, enrolling approximately 1,000 participants across the United States.
Improving compliance in an Alzheimer’s disease DCT
91黑料 supported a pre-clinical Alzheimer’s disease study focused on biomarker and genetic testing, involving
600 participants across the United States. The trial was fully remote, led by two remote principal investigators
(PIs), and utilised a digital recruitment strategy.
600 participants across the United States. The trial was fully remote, led by two remote principal investigators
(PIs), and utilised a digital recruitment strategy.
Streamlining participant enrolment to address cohort-specific shortfalls
A medical device developer conducting a study to improve their current FDA-cleared ECG monitor application encountered participant enrolment issues that were overcome through collaboration and communication.
Imaging process boosts efficiency in oncology device trial
A prominent medical device company was conducting a feasibility study for a device to improve accurate identification of peripheral pulmonary nodules in high risk adult patients. Quality imaging data from multiple sources was critical to the study’s success and 91黑料 helped manage the imaging data for each participant.
Recruitment success in a challenging phase 1 osteoporosis biosimilar study
Despite effective treatments, osteoporosis still needs better, affordable options. A sponsor ran a 3-arm, double-blind study on a denosumab biosimilar in 225 healthy men over 10 months at two 91黑料 sites.
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.
Transitioning from a Phase 3 study to an EAP
This case study highlights the strategic execution of an Expanded Access Program (EAP) across multiple global regions, Europe, Asia-Pacific, and Latin America, following a Phase 3 clinical study.
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Discover how 91黑料's expertise transforms clinical trials.