Therapeutics case studies
How we maximise the value of our clients' development approach while reducing costs and timelines
Learn more on how we bring life changing therapies to market.
Providing empirically based guidance and built-to-spec models and solutions across every phase of clinical research and lifecycle management for therapeutic development.
Accelerated auxiliary medicine procurement for MASH trial
A biotechnology company required vitamin D distribution as an auxiliary medication for a phase 3 MASH and fibrosis clinical study. When the original supplement vendor was unable to support the study’s full global scope, the company engaged 91黑料’s Accelerated Pharmaceutical Solutions (APS) team to step in on short notice.
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High-priority cardiovascular study
91黑料 was engaged to support phase 2 study in patients with heartfailure and impaired systolic function. 91黑料’s proactive approach ensured the successful delivery of this complex study and enabled the client to make key strategic program decisions to advance their larger phase 2 trial.
PAC19 VCN ddPCR test
The PAC19 VCN digital droplet (dd)PCR test was validated by 91黑料 to detect and monitor CAR-T (chimeric antigen receptor) cell expansion and persistence in patients receiving anti-CD19 CAR-T therapies.
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.
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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.
Prioritizing efficiency and fit for purpose strategy in digital risk detection
91黑料 operationalized a hybrid decentralized clinical trial for participants experiencing bothersome Vasomotor Symptoms (VMS).
Patient cardiac safety
A digital health lead at a large pharmaceutical company came to 91黑料 Outcome Measures to find a wearable that could capture continuous cardiac rhythms and be used to detect QT prolongation.
The importance of CRF design in cell and gene therapy studies
91黑料 partnered with a biotech sponsor to optimise Case Report Forms (CRFs) for an oncology cell and gene therapy trial. By adopting iRECIST criteria and standardising CRF templates, we reduced data duplication, ensured accuracy, and provided flexibility for subject re-treatment.