Support of Israeli Sponsor to Transition to the US Market

Background > Israel-Based Stem Cell-Focused Sponsor Selects PRC Clinical for Us Trial

PRC Clinical was contracted by an Israeli-based stem cell-focused sponsor to help them transition to the US market. PRC Clinical helped the client run a full Phase II clinical trial with 48 patients over 3 clinical sites in the United States. The sponsor chose PRC Clinical based on our strong ALS experience.

Challenge > Sponsor’s First US-led Trials

The sponsor had a limited presence in the United States, and needed a local partner to expand their capabilities and their team. PRC Clinical provided regulatory and clinical trial management services. Additionally, PRC Clinical provided clinical data management (CDM) services to the sponsor through strategic alliances.

Solution > PRC Clinical Unique Experience of US And Israeli Clinical Studies

PRC Clinical has the experience and the regulatory knowledge to help foreign sponsors bridge the gap to start a US-led clinical trial, and establish themselves in the US market. PRC Clinical is familiar with the Israeli regulatory environment, and is a unique partner to guide Israeli sponsors and make it possible to start a study in the United States.

PRC Clinical Case History > Key Highlights

• Detailed knowledge of US and Israeli clinical trials.
• Strong strategic alliance to provide high-quality CDM services.
• Experience with global Phase II and III clinical trials.