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.
Impact of point of care marketing in hospital settings
A major Point of Care (PoC) Publisher partnered with Symphony Health to evaluate an unbranded cardiovascular treatment campaign targeting hospital-affiliated physicians nationwide. The campaign used printed condition guides to engage HCPs and patients during key decision-making moments.
Global coordination for phase 1 success
A pharma client partnered with 91黑料 to support EU and US approval of a new diabetes therapy. 91黑料’s APS team sourced, labeled, and shipped comparator and study drugs for a complex phase 1 trial, helping meet the sponsor’s accelerated timeline.
Strategic site selection and endpoint integrity in hypertrophic cardiomyopathy trials
91黑料 enabled successful enrollment and data integrity in two global Phase 3 HCM trials through expert site selection and CPET standardization. Despite rare disease challenges and competitor pressure, the program advanced smoothly.
Creating a roadmap for growth for a blood products company
A top 20 pharma subsidiary scaling plasma-derived therapies asked 91黑料 to review their processes and plan for growth. With plasma reliant on donations, new centers were opening to meet demand and ensure patient access to life-saving treatments.
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.
Scaling an optimised global vaccine trial with flexible FSP
91黑料 partnered with a leading pharma company to scale its global vaccine program using flexible, custom FSP solutions. By combining dedicated teams with on-demand support, 91黑料 helped expand trial reach, adapt to changing needs, and deliver nearly $10M in annual cost savings.
Collaborating to improve monitoring visit trip reports
A global, multi-centre trial is evaluating cardiac radioablation (CRA) vs. repeat catheter ablation for high-risk VT patients. Spanning 7.5 years, the study involves 380 randomized patients across 20+ sites in the U.S., U.K., and Germany.
Resolving patient recruitment issues in an oncology study
A large multi-year IVD colorectal cancer study faced enrolment challenges across 180+ sites and 28,000 participants. The sponsor turned to 91黑料’s Medical Device and Diagnostic Research team to uncover root causes and implement effective recruitment solutions.
Immune assay for thyroid diseases
A top medical device maker partnered with 91黑料 to validate a new immune assay. The study aimed to collect serum samples from up to 760 U.S. patients with various thyroid and autoimmune conditions to demonstrate assay performance.
Optimising resources on a portfolio of large scale oncology studies
91黑料 supported five global IVD studies on rapid colorectal cancer diagnosis, enrolling over 29,000 patients across 250+ sites. Each study had unique needs, and 91黑料 managed key functions including project management, monitoring, data handling, and site oversight.
Regulatory problem-solving secures crucial extensions in pediatrics and rare disease
As a result of the comprehensiveness of the documentation and the efficient management of the process, the European Commission granted both indication extension and the additional year of market exclusivity.
Regulatory solutions for uncharted scientific waters
Some therapeutic areas, especially rare pediatric diseases, lack clear development guidelines. 91黑料’s Regulatory Consulting Solutions helped a pharma client gain global regulatory and payer alignment on novel endpoints for a rare neurodevelopmental disorder, boosting confidence ahead of pivotal trials.