Newsletter | March 16, 2023

03.16.23 -- Strategic Procurement For Emerging Pharmas & Biotechs

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Outsourcing Models
Strategic Procurement For Emerging Pharmas And Biotechs

Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.

Think Your Large CRO Can’t Fail? Think Again

Discover how clinical research services must wade through a bog of incomplete information, and sometimes outright misinformation, when it comes to seeking reliable partnerships.

Moving From Early Phase To Phase 2 Studies: How A CRO Can Help

Understand why biotech companies often engage a contract research organization (CRO) with the required experience and capabilities for running successful clinical trials.

Addressing Rare Disease Drug Product Manufacturing Challenges

Handling development and manufacturing challenges for orphan drugs requires experience, expertise, and scalable technologies, along with a flexible and agile supply chain.

Regulatory & Compliance
6 Novel Mock BIMO Regulatory Inspection Exercises

Don't get caught on your heels. Conducting a mock regulatory inspection in preparation for an FDA, EMA, or other regulatory visit is a key industry inspection readiness activity. Explore six new inspection exercises to help your team prepare for the big day(s).

The Composition And Value Of A Portfolio Analysis

One of Premier Consulting’s differentiating offerings is portfolio analysis: a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of products within a sponsor’s portfolio.

Streamline Your Regulatory Process

The Advarra eRegulatory Management System (Advarra eReg) provides integrated protocol, staff, and institution documentation to streamline regulatory processes and enhance compliance.

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  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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