Clinical Study Initiation / Project Management

Clinical Study Initiation / Project Management

After your medical device clinical trial strategy is developed and your study endpoints are in place, Aptiv Solutions will assist you with a full range of study initiation services. Our project managers and clinical trial experts will oversee day-to-day study activities, giving you confidence that all the relevant data are captured, collected, and interpreted to support your study goals. Your project manager will work with you to:

  • Identify and qualify the best study sites and investigators for your medical device
  • Conduct pre-study qualification visits to assess your sites
  • Prepare your team and support you during initial meetings with the FDA and other regulatory bodies to introduce your medical device and negotiate your pre-clinical trial and clinical trial test plans
  • Prepare your study materials, including an appropriate study protocol, Case Report Forms (CRFs), and informed consent documents
  • Prepare any necessary documentation for IRB and/or Ethics Committee approval
  • Conduct pre-investigational visits to train the clinical trial site staff on the protocol, study materials, applicable regulations and Good Clinical Practices for your medical device

You will receive routine reporting and communication as your study progresses to keep you apprised of data accrual and data quality on a site-by-site basis, and to keep you and your study team on track.