Source: InVentiv Health
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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.
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