Clinical Trial Support

We offer full contract research organization (CRO) services around the globe. Our leadership team has significant expertise in biomedical research. We design and conduct clinical trial research projects in many therapeutic indications, including wound healing, oncology, CNS, diabetes, cardiovascular disease, infectious diseases and more.

We also support all stages of product development, including clinical development and manufacturing, addressing pharmacovigilance issues as they arise.

We'll take your product through the entire approval process, from creating the regulatory approval strategy to conducting trials and writing the marketing approval application.

We offer comprehensive services in project management (Phase I-IV, BE/BA and PK/PD), regulatory affairs (FDA applications and meetings, applications to international health authorities and GxP compliance audits), clinical operations, adaptive study designs, statistical analysis, data management, medical monitoring, safety and pharmacovigilance and general consulting.

Our team of regulatory experts guides you from strategy to approvals. NSF works with regulatory authorities around the world, and we consider regulatory strategies at every step of the way to minimize timelines and improve the chances of success for your product registration. ​During your company's interactions with global regulatory agencies, our team of former FDA regulators provides superior representation, strategy and support.

Our submission strategies support early clinical development, product registration and late-phase trials in a global setting.

Backed by more than 20 years of industry experience, our team develops customized submission strategies designed to save you time and money. Receive expert guidance throughout your entire project lifecycle in order to meet regulatory standards for electronic submissions and ​prepare and deliver your application with confidence.

Our services also include:

• eCTD compliant FDA applications and submissions, including IND, IDE, 510(k), NDA, BLA, PMA, ANDA, orphan drug designation (ODD), de novo, compassionate use, emergency use authorization (EUA) and breakthrough therapy designation
• Regulatory strategy
• CMC expertise
• International regulatory agency submissions (CTA, IMPD, MA, CE, and others) and meetings
• GLP, GCP, GMP and GAP audits and certifications
• Clinical research results evaluation
• Clinical development plan, including statistical support
• Product development assessments
• Preclinical development plan
• Capture of preclinical study data to meet SEND requirements