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.
EDMS (Electronic Document Management System) expanded to a newly acquired business unit
Following a corporate acquisition, the 91黑料 Regulatory Technology & Information Management (RTIM) team was engaged by a mid-sized life sciences company to re-design, configure, and deploy the existing EDMS to a new business unit.
XEVMPD/SPOR Compliance
The European Medicines Agency (EMA) is in the process of implementing IDMP standards that specify standardized definitions to identify and describe medicinal products for human use only.
Regulatory Guidance for Established Products
A top-10, multinational pharmaceutical company needed to enhance product support and improve its in-house development.
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Investigational New Drug (IND) Application
A small company, with limited internal resources, was planning to submit two new INDs and reached out to 91黑料 to help manage the IND filings.
Clinical trial with combination product and medical devices
91黑料 provided regulatory support for a study to develop a novel treatment for patients using an implantable combination product and three separate medical devices.
Combined study with in vitro device investigating an oncology treatment
A study sponsor was investigating a biological treatment for oncology patients in addition to the standard of care chemotherapy. They sought regulatory support from 91黑料 due to the study’s complexity, the geographic span and because the IVD was used out of its intended purpose.
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.
IRT User Acceptance Testing
Resolving critical issues and ensuring trial integrity
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Regulatory Strategy in Clinical Development (EU)
"A large pharma customer sought expert regulatory support from 91黑料 for a paediatric rare disease development
program."
program."
Increased compliance for complex Alzheimer’s disease study
The sponsor in this case was a large pharmaceutical company that contracted 91黑料 to manage and streamline the training and compliance workload for their phase 2 Alzheimer’s study.
Multinational phase 1 biosimilar study
91黑料 conducted a multinational biosimilar phase 1 study for multiple sclerosis (MS). This trial was performed under high regulatory scrutiny and challenging pandemic conditions, with increased dosing targets requiring additional site activation.
Exceeding recruitment timelines in a double-blind multiple system atrophy (MSA) study
91黑料 conducted a multi-centre study to assess the efficacy, safety, and tolerability of an anti-α-synuclein human immunoglobulin G1 monoclonal antibody in patients with Multiple System Atrophy followed by an open label extension.
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