NORTH AMERICA OPERATIONS

If market authorization in the US is your target, or if your drug’s indications require an additional pool of patients, SCOPE’s dedicated US team will provide you with all the services you need. We are experts for European clients seeking to realize US projects.

SCOPE has gathered many years of experience in clinical research with local CROs in the United States, before the company in response to increasing requests by its clients, decided to establish its own US business in 2015. Pittsburgh, Pennsylvania, a center of biotechnology with renowned universities and hospitals in the North East Region, proved to be the perfect location for SCOPE’s first US office. It is managed by a highly educated and committed local team with expertise in drugs, biologics, and devices (Class I-III).

For you as a European client, the close cooperation of SCOPE project management and operations teams in Europe and the US brings about a multitude of advantages: With your main contact person at SCOPE being based in Europe, time difference is no longer an issue. Communication and collaboration are streamlined to meet different requirements and expectations. Standard operating procedures and working procedures are harmonized; the high SCOPE standard of quality data is ensured at all times.

SCOPE’s experts will accompany you through all stages of your product’s journey. Your clinical trial will benefit from our experience in developing regulatory strategies for the FDA, Health Canada and the EU, in addition to our expertise with NIH and DoD federal grants. What’s more, you will enjoy all the advantages of a larger international organization; Our Pittsburgh office is part of the SCOPE Group with over 20 years of experience in supporting clinical trials and regulatory submissions for pharmaceutical, biotechnology, and medical services. With SCOPE having 15 offices worldwide, our local project management team operates in the North American time zones, but also has global reach for hard-to-find populations.

Our experienced local US team will give you regulatory support during pre-IND, IDE, de novo, and other formal meetings, as well as scientific advice with the FDA. Our experts will accompany your complete submission process in the US and Canada.

SCOPE’s Pittsburgh office covers 25 US states, Toronto and Montreal, while other US states along with the Mexico and Puerto Rico regions are covered by strategic satellite offices in the South, Southwest, Pacific Northwest and Western regions of the US.