Rare Disease And Orphan Drug Research

Source: INC Research/inVentiv Health


While developing drugs to treat rare diseases is more viable from a business perspective than ever before, the clinical research and go-to-market planning process is still fraught with challenges. Regulations, protocols, logistics, and reporting are all different when patients are scarce, the stakes are high, and treatments are complex.

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INC Research/inVentiv Health has amassed a unique group of operations staff with worldwide experience in supporting rare disease research and commercialization for both pediatric and adult populations.

Support From Pre-Clinical Through Post-Approval Phases

  • Provide regulatory intelligence and strategy development
  • Guide meetings with health authorities
  • Provide analytical/bioanalytical assays and analyses
  • Design clinical trial protocols
  • Conduct behavioral research with patients and caregivers to support recruitment messaging
  • Engage with advocacy groups
  • Create study awareness through PR and educational campaigns
  • Manage trial operations from study start-up through close-out
  • Provide strategic consulting to support infrastructure, payer landscape, launch planning and market access, and reimbursement

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