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Clinical Development

orphan reach is a full-service CRO with clinical operations in place since 2002. We offer global clinical development services that allow our clients to take their precious IMP from early trials in patients to Marketing Authorization. From Project Management to Clinical Monitoring, Safety & Pharmacovigilance, Quality Assurance, Data Management and Biostatistics: we provide a seamless CRO service. What makes us stand out is the refinement of our processes and adaptation of services to accommodate clinical trials involving small patient numbers. Dealing efficiently with the unique medical, scientific, clinical and commercial challenges within the rare disease domain, is what our clients appreciate.

We offer the whole spectrum of clinical development services including:

• Project Management

• Quality Assurance

• Medical Writing

• Regulatory Affairs

• Drug Distribution

• Clinical Monitoring

• Pharmacovigilance

• Medical Monitoring

• Data Management

• Biostatistics

We also foster close relationship to key opinion leaders, to ascertain real-life experience and involve them very early in the development program. We train and educate investigators and lead initiatives to improve disease awareness. We link with patient advocacy groups and obtain valuable input from patients themselves. We establish a patient recruitment plan and explore patient registries and referral sites. We proactively collaborate with health authorities early in the development program.

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