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Alquest services: Clinical trial support for medical device firms

Alquest provides comprehensive support in essential aspects of clinical research. Since our inception in 1993, we have supported the approvals and commercialization of hundreds of medical devices. Our clinical expertise spans all manner of technologies, therapies, indications, and business strategies.

 

While Alquest specializes in IDE studies, we also provide cost-effective support for registries and post-market studies, as well as FDA-mandated Condition of Approval studies.

 

Clinical Design

If your clinical protocol is not yet developed, or is partially developed, Alquest can assist in its completion. To be of full service to clients, we require a clear understanding of your clinical endpoints, marketing claims, regulatory objectives, and reimbursement and marketing strategies. This comprehensive view enables the best possible clinical design to support your product’s commercialization.

 

Clinical Trial Conduct

Clinical trials are the most costly phase of development due to delays and false starts. Alquest’s approach to minimizing risk is to assign highly experienced, highly competent clinical professionals who have supported many device trials during their careers. Our Project Managers, CRAs and Clinical Monitors know GCP, ICH and FDA standards of data integrity, patient protection and regulation. Our mantra is “Working smart from the start.”

 

Alquest’s support of clinical trials spans study startup, ongoing study activities, the reporting phase, through study closeout. Activities include

  • Biostatistics
  • Data Management/database
  • Site qualification, selection and initiation activities
  • Site management
  • Study management and administration
  • Clinical monitoring
  • SAE reporting
  • Study closeout
  • Analysis
  • Final clinical report

Within each function, Alquest follows comprehensive task procedures developed from the experience of having supported hundreds of medical device clinical trials. Whether your SOPs or our own, Alquest is comfortable following the applicable procedures.