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.
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