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Consultative Services

The Lupus Therapeutics Consulting service provides a way to harness drug development expertise and LuCIN key opinion leaders, who are international luminaries in the field. The Lupus Therapeutics Consulting service connects these individuals with industry for collaboration on lupus clinical research development and planning. Through this effort we seek to improve the quality and outcomes of lupus clinical trials, improve recruitment rates, and significantly reduce the barriers in the clinical trial process. Early engagement between industry and LuCIN through the Lupus Therapeutics Consulting service leads to more effective clinical development plans and pragmatic study designs, leading to faster development of potential new therapies for people with lupus.

We offer a seasoned team of experts with significant lupus experience to provide customized consulting services at any phase of the drug development or clinical research process. Consulting may include input on:

  • Pipeline prioritization and clinical development plans
  • Protocol review and trial design
  • Acceptable endpoints for lupus clinical studies
  • Regulatory planning and meetings
  • Patient reported outcome development plans and tools
  • Protocol operations feasibility

We organize and conduct Patient Advisory Board panels with lupus patients to solicit feedback and gather direct insights on a variety of key clinical study elements, including:

  • Protocol/study design
  • Study synopses
  • Assessment schedules
  • Informed consent form design
  • Study communications (i.e. patient recruitment materials)
  • Clinical trial medicine kits
  • Clinical trial technologies and procedures
  • Other study-specific materials, such as post-trial communications

Learn more about ongoing clinical trials being conducted within LuCIN