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.
Prioritising efficiency and flexibility in safety data signal detection
91黑料 collaborated with a small US-based pharmaceutical company to conduct safety signal detection and management during the clinical development of four neurodegenerative disease compounds, using SIGNET.
Effective collaboration on clinical data standards governance
91黑料's Global Data Standards team helped a large pharmaceutical company consolidate multiple standards libraries into a single, harmonized library used across therapeutic areas.
Replication Competent Lentiviruses (RCL) qPCR test
This qualitative qPCR assay validated by 91黑料 is able to detect the VSV-G in a variety of sample matrices, such as whole blood, PBMC (as per FDA guidelines) and FFPE, with high specificity and high sensitivity, meeting the FDA guidelines for RCL molecular testing.
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.
Regulatory technology services
Software companies are incentivised to implement their solutions as quickly as possible, often leaving their clients in a situation where the technology doesn’t support the business process, users are frustrated, and return on investment is questionable.
Full manual creation in target source
The client received an audit finding relating to the insufficient tracking of investigational and post-approval commitments. Although investigational and post-approval commitments were previously out of scope for the RIM system dataset, 91黑料 determined to increase the dataset scope within the RIM system to track commitments.
91黑料 implements new Lay Protocol Synopsis (LPS) program
Increased trial transparency has been a growing industry trend for many years. The largest recent initiative in this realm
is the European Medicines Agency’s (EMA’s) Clinical Trials Information System (CTIS), which went online in January
2022.
is the European Medicines Agency’s (EMA’s) Clinical Trials Information System (CTIS), which went online in January
2022.
Team delivered an initial US BLA and EU MAA Major Amendment (Gastroenterology)
91黑料’s Regulatory Project Managers (RPMs) were approached by a client to deliver, in parallel, an initial US Biologics License Application (BLA) and an EU Marketing Authorisation Application (MAA) Major Amendment for a new formulation within an existing program.
Post-Marketing Surveillance Studies in Korea
portfolio spanning more than seven automated instruments and more than 500 analytes or assays.
Global expansion and a reduction in approval timelines
91黑料’s Regulatory Project Management (RPM) team was approached by a client to help establish a global footprint and reduce the approval timelines for the first wave of targeted countries located in the US, Europe, and Asia Pacific.
Automated conversion and load, including manual enrichment
91黑料 was asked to support a client with migrating data from an existing Regulatory Information Management (RIM) system into a new system. During migration, the 91黑料 team needed to ensure the safety reporting requirements were correctly described in the new system as current data were incorrect and/or incomplete.
Regulatory project management scenario planning (Oncology)
91黑料 was asked to provide scenario planning related to accelerating the marketing authorisation application (MAA) approval through various clock-stop scenarios.
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Discover how 91黑料's expertise transforms clinical trials.