Medical Device & Diagnostics Research case studies
See how we are accelerating the development of device and diagnostics
Explore our library of case studies for medical device and diagnostics research solutions.
Explore this library to learn how our dedicated team at 91黑料 can assist with all phases of your clinical trial development and testing by supporting you in designing, implementing and managing clinical trials for your devices, diagnostics and combination devices, to successfully bring your product to market, faster.
Streamlining global budget development & negotiation
A leading medical device company partnered with 91黑料 to streamline budget development and negotiation for a retrospective data collection study involving 158 participants, 26 sites, and 5 countries across the United States and Europe.
Navigating consent, regulatory requirements, and data challenges in a multi?country vascular graft study
A medical device company partnered with 91黑料 to conduct a retrospective study using existing patient data from European sites, rather than enrolling new patients. Sites contributed up to five years of historical information across multiple vascular graft cohorts.
Streamlining participant enrolment to address cohort-specific shortfalls
A medical device developer conducting a study to improve their current FDA-cleared ECG monitor application encountered participant enrolment issues that were overcome through collaboration and communication.
Imaging process boosts efficiency in oncology device trial
A prominent medical device company was conducting a feasibility study for a device to improve accurate identification of peripheral pulmonary nodules in high risk adult patients. Quality imaging data from multiple sources was critical to the study’s success and 91黑料 helped manage the imaging data for each participant.
Supporting an ANDA submission for a drug-device product
A Canadian mid-size pharma company partnered with 91黑料 to support FDA approval of a generic injectable for opioid overdose treatment. 91黑料’s Regulatory Affairs team guided the sponsor through the ANDA process, including pre-submission, filing, and responding to FDA review queries.
Streamlining clinical operations
91黑料 successfully streamlined clinical operations during a post-market registry study by adapting sponsor SOPs mid-study, enabling a seamless transition to 91黑料-led project management while maintaining operational continuity and site performance.
Partnering to provide vital regional support on a global medical device study
91黑料 was selected as a European partner CRO for a drug-coated balloon device study, supporting regulatory services, study start up and monitoring activities, and safety reporting service for study sites located across Europe. The device consequently received CE Mark certification and FDA approval.
Ensuring consistent source data monitoring for a global cardiology study
This global, double-blind cardiology study evaluated an atrial shunt’s impact on quality of life and heart failure symptoms in 260 patients. Conducted over 4.5 years at 66 sites, it included a crossover option and five-year follow-up.
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.
Overcoming under-enrolment for an assay study on neonate sepsis
A two-year non-interventional study evaluated an interleukin assay for diagnosing neonatal sepsis. Over 500 samples were collected across 24 U.S. sites, using control and treatment cohorts to assess biomarker accuracy and diagnostic performance.