Clinical Affairs Support & Outsourcing

Clinical Affairs Support & OutsourcingThe success of a medical device clinical trial depends highly on the accuracy of the data collected. The AlvaMed clinical affairs team works in concert with you to ensure that your clinical trial data is collected, entered, cleaned and reported in accordance with the protocol and other requirements. The ultimate goal is to provide you with high quality, reliable data for analysis. Our clinical affairs team will work closely with you to ensure that the clinical investigation plan appropriately represents you to Institutional Review Boards (IRB)/Independent Ethics Committees (IEC) and adheres to Good Clinical Practice (GCP) guidelines, as well as all federal and local regulations. We closely follow Good Clinical Practices (GCP), the European Clinical Trial Directive (2001/20/EC) and ISO 14155 – Clinical Investigation of Medical Devices for Human Subjects. We are ISO 13485 certified. Depending on your budget and availability of in-house resources, AlvaMed can be involved in all or part of your clinical trial activities.

Services Offered:

  • Clinical trial management
  • Clinical trial study design and protocol development
  • Clinical Document Creation & Management
  • Clinical Trial Monitoring (Onsite & Remote)
  • Clinical postmarket study design and management
  • First-in-man clinical trial design and management
  • Pre-trial site evaluation and qualification
  • Paper or EDC data collection capability
  • Clinical trial data management
  • Clinical database development, entry, processing, querying, maintenance and reporting
  • Training for clinical study staff and site level staff
  • Creation of study progress reports
  • Interfacing with IRBs, Ethics Committees and other agencies for clients
  • Clinical Events Committee/Data Safety Monitoring Board support network
  • Regulatory support

Case Studies:

Clinical Study Management