This week we celebrated with a client the success of a clinical trial approval through New Zealand Medsafe and Ethics in super quick time
Document Review: 5 days
Medsafe Approval: 22 days
Ethics Approval: 18 days
Proficient review of documents and efficient processes to address any queries, as well as a good understanding of Medsafe and Ethics timelines are good reasons to work with Pharmaceutical Solutions to conduct clinical research in Australia and New Zealand.
Pharmaceutical Solutions works with New Zealand local authorities and sites to achieve first patient recruitment for global study.
Client Announces First Patient Dosed in Phase 2 Study of Pegylated Interferon Lambda in Hepatitis D Virus (HDV) Infection
LIMT HDV: Lambda Interferon MonoTherapy in HDV Study
Focused on the development and commercialization of targeted therapies for rare diseases, the client announced today that the first patient was dosed in the Phase 2 LIMT HDV (Lambda Interferon MonoTherapy in HDV) study, a monotherapy trial of pegylated interferon lambda 1a ("Lambda") as a potential treatment for chronic hepatitis D virus (HDV) infection. LIMT HDV is a 30-patient study designed to evaluate the safety, tolerability and efficacy of two dose levels of Lambda after 48 weeks of treatment. LIMT HDV is an international study currently enrolling at University of Auckland in New Zealand.