Clinical Research and Development

Helping biotech and specialty pharma companies navigate the complexities of clinical studies.

PREMIER PERSPECTIVE

Product Development Checklist: Considerations for Each Stage of the Drug Development Process

Developing a new biopharmaceutical product is a lengthy, high-stakes journey. A comprehensive plan and the right regulatory and therapeutic expertise can significantly accelerate the development timeline and increase the likelihood of marketing success.

Advancing from Research to Development: What Can Go Wrong?

The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval.

Expert guidance, every step along the way

We’ve unified the disciplines that underpin successful clinical research and development, from dedicated rapid study start-up staff to Premier-trained project managers and fast-track application expertise. With so much at stake – livelihoods, expectant investors, and most important, the patients who entrust to us their health and safety – there is no room for shortcuts.

Our experienced research professionals are capable of managing even the most complex clinical research studies from Phase 1 to Phase 4. Our therapeutically focused teams have the knowledge and experience necessary to effectively manage situations as they arise, and our approach is firmly grounded in comprehensive project management principles and well-defined processes.

Service Areas:

Quality Management & QA

Safety & Pharmacovigilance

Project Management

Data Management

Combination Products

Functional Service Provider

Clinical Research and Development Experts

Ashish Jain, MPharm

SVP, Asia-Pacific

Nicole Stansbury

SVP, Global Clinical Operations,

Stacy Weil, DHI

Senior Vice President, Business Operations and Patient Centricity

Related Capabilities

Adding value at every step in the process, we provide expertise in strategic product development, global regulatory consulting, and technology applications to ensure data integrity, process efficiency, and timely analytics and reporting.