Rare disease clinical research studies pose several challenges, including difficulty in diagnosis, site selection, patient enrolment and retention, and complying with regulatory requirements.
One out of every five marriages in Turkey is consanguineous marriage resulting in much higher incidences of rare hereditary inherited diseases as compared to Europe and the United States.
Orphan drug early phase clinical and proof-of-concept studies can be conducted at sites approved and inspected by the Ministry of Health. Monitor has excellent relations with these select sites as well as the experience to perform their initial application and follow-up inspection applications to the Ministry of Health.
Rare Disease pivotal clinical research studies demand a full-service CRO with expertise in enrolling rare disease patients. Besides, from designing study protocols to informed consent forms, these studies require specialized expertise. Moreover, a significant number of these patients are paediatric patients, which requires different ethics and regulatory approval procedures and realistic study feasibilities. As a leading full-service integrated CRO, Monitor has the experience, know-how, and resources to help our sponsors in orphan drug development.