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.
Use of Real World Data to fulfil post-approval requirements
A large pharma company submitted a New Drug Application for a targeted therapy treating a rare tumour subtype. To support safe use, a companion diagnostic PMA was filed in parallel with the FDA’s CDRH.
CMC and local regulatory expertise deliver timely anti-cancer drug approval
An international biopharmaceutical company based in the EU contracted 91黑料 to support a new biologic drug application in Canada for an anti-cancer therapy for diffuse large B-cell lymphoma (DLBCL) under advance consideration.
Overcoming enrollment challenges in an early phase obesity trial
A leading multinational pharmaceutical company partnered with 91黑料 to conduct a phase 1 obesity study assessing the safety and tolerability of a new investigational oral amycretin therapy.
Complex phase 1 obesity study
91黑料 was once again selected as a partner to conduct a phase 1 study in individuals who are overweight or have obesity, evaluating the safety and tolerability of a new subcutaneous GLP-1 and amylin peptide formulation.
Extensive patient access and recruitment strategies
A large pharmaceutical company was conducting a Phase 2 study for adults with a BMI of 18-32. They contracted 60 US sites, including 9 Accellacare sites to recruit for two cohorts and conduct the study.
Eliminating enrolment delays to bring an AI-enabled SaMD to market
A medical device developer faced clinical evaluation timeline delays due to under-enrolment. Discover how the collaborative partnership between the sponsor and 91黑料’s Medical Device & Diagnostics Research team steered the study from patient enrolment to FDA submission and approval.
Optimising site selection in a rescue study
A pharmaceutical sponsor launched a global trial for elderly UTI patients, opening 125 sites across 15 countries. Enrolment lagged at 1 patient per site per month, with 70% non-enrolling. 91黑料 was brought in to rescue the study.
Protocol optimisation
A virtual biotech start-up acquired an immunomodulatory mechanism targeting inflammatory pathways. It had undergone phase 1 and small phase 2a studies. With urgency to advance development and limited resources, the client proposed two separate studies, posing challenges in complexity, timeline, and budget. The client turned to 91黑料 to streamline development.
Exceeding late phase study recruitment goals
Over 19 days, 91黑料 conducted a focused site engagement programme to increase patient screening and accelerate enrolment of a late phase multinational, multicentre study to evaluate a treatment for pulmonary disease.
Re-adjudicating a respiratory and cardiovascular trial during COVID-19
The FDA advised the trial to re-adjudicate so that the study accounted for the effects of COVID-19 on the trial outcomes. To ensure that the trial data would be submitted to the FDA as scheduled, 91黑料 needed to coordinate re-adjudication of 700 endpoints within a compressed three-month timeline.
Pain proof of concept
91黑料 had he objective to develop a smartwatch mobile app combination that can be used to alert patients, and physicians and drug development teams to physical behaviours that may exacerbate patients’ pain.
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Allergic rhinitis
A Biotech client contracted 91黑料 to conduct a Phase III study that was a double-blinded, randomised, multinational, multicentre, placebo-controlled trial.