Case Studies

Inspire Pharmaceuticals, a North Carolina-based biopharmaceutical company, focused on developing and commercializing prescription products for ophthalmic and pulmonary diseases previously worked directly with investigative sites to manage clinical trials for its initial drug portfolio. Generally reluctant to outsource the management of studies, the company felt it was good at developing relationships with investigators and worked hard to build and maintain those relationships.

Learn how Clinipace Worldwide is helping Prometheus Laboratories optimize their patient enrollment and monitoring in two early phase oncology trials.

Therapeutic area:  Oncology (metastatic melanoma)

Global region:  North America

Operational focus:  Patient enrollment, technology integration

Clinipace Worldwide was employed to “rescue” and augment the monitoring of the trial, effectively manage and achieve milestones, meet project timelines, and optimize resources and communication pathways. The “David of CROs among a sea of “Goliaths” restored trust to the trial offering agility, efficiency and consistency that traditional models often lack.

Andrew Asimos, MD, Director of Emergency Stroke Care at the Carolinas Medical Center in Charlotte, NC, and site investigator for the North Carolina Collaborative Stroke Registry (NCCSR) wanted to validate guidelines for risk-stratifying patients who experience a Transient Ischemic Attack (TIA), also called a mini-stroke. Developed in a landmark 2000 Kaiser Permanente study, the guidelines purport to predict whether these patients would go on to have a full-fledged stroke in the short term.

Clinipace's integrated, technology-driven data management services provided visibility into key research metrics and instant access to clinical data, providing a perfect solution for ImproveCareNow's care collaborative. The new registry was deployed to over 200 sites without requiring extensive and expensive training.

With FDA approval, the On-X valve would be the only mechanical heart valve available in the U.S. for low-dose anticoagulation therapy. The randomized control clinical trial of the On-X Prosthetic Heart Valve involves up to 1,200 patients across 40 different medical centers nationwide. Compared to other medical device trials, theirs is a large study. Stakes were high in finding an experienced company with the software to manage, track and report on all facets of the study.