Health Decisions
Premier Research is dedicated to transforming life-changing ideas and breakthrough science into new medical treatments through innovative research solutions. They focus on clinical research, consulting, and technology-powered solutions to accelerate the path from development to approval, emphasizing expertise, strategic insight, and a patient-centered approach. Their mission is to help companies bring their innovations to market faster and more efficiently, supporting every step of the development lifecycle with a comprehensive suite of services and a focus on quality, safety, and regulatory compliance.
Industries
Nr. of Employees
medium (51-250)
Services
End‑to‑end clinical development services covering study design, operations, monitoring, data management, safety, regulatory support, and submission preparation.
Design and conduct of registries, natural history studies, and post‑marketing surveillance to support endpoint identification and regulatory submissions.
Provision of scalable, embedded functional teams to support sponsor needs across clinical operations, data management, biostatistics, and other functions.
Strategic regulatory and program planning including development pathway selection, agency engagement preparation, and submission planning across drug, biologic, device, and diagnostic programs.
Integrated translational development services including nonclinical strategy, CMC input, clinical pharmacology, and model‑informed approaches to de‑risk programs.
Deployment and support of study management and eClinical platforms, RBQM tools, and analytics to enable real‑time quality and operational decision‑making.
End‑to‑end clinical development services covering study design, operations, monitoring, data management, safety, regulatory support, and submission preparation.
Design and conduct of registries, natural history studies, and post‑marketing surveillance to support endpoint identification and regulatory submissions.
Provision of scalable, embedded functional teams to support sponsor needs across clinical operations, data management, biostatistics, and other functions.
Strategic regulatory and program planning including development pathway selection, agency engagement preparation, and submission planning across drug, biologic, device, and diagnostic programs.
Integrated translational development services including nonclinical strategy, CMC input, clinical pharmacology, and model‑informed approaches to de‑risk programs.
Deployment and support of study management and eClinical platforms, RBQM tools, and analytics to enable real‑time quality and operational decision‑making.
Expertise Areas
- Clinical trial management
- Translational pharmacology and model‑informed drug development (MIDD)
- Clinical pharmacology and PK/PD
- Biostatistics and clinical data management
Key Technologies
- Model‑informed drug development (MIDD)
- Population PK/PKPD modeling
- Noncompartmental analysis (NCA)
- Clinical trial simulation
News & Updates
Meet with us to explore next steps to a smarter, faster path to approval.
Identification of relevant data and how such data can be leveraged for regulatory submission.
Expert insights on MIDD PK/PD modeling strategies.
Announcement of a dedicated oncology division to support early- and late-phase trials.
Premier Research delivers comprehensive clinical trial solutions, from protocol development to regulatory submission.
Focus on innovative strategies to accelerate clinical trials for rare diseases.
Meet with us to explore next steps to a smarter, faster path to approval.
Identification of relevant data and how such data can be leveraged for regulatory submission.
Expert insights on MIDD PK/PD modeling strategies.
Announcement of a dedicated oncology division to support early- and late-phase trials.
Premier Research delivers comprehensive clinical trial solutions, from protocol development to regulatory submission.
Focus on innovative strategies to accelerate clinical trials for rare diseases.