Clinical Supplies Consultant and Management

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Clinical Supplies Consultant and Management -

Our Mission: To provide expertise and services in managing the entire clinical trial supply chain, from planning and forecasting to sourcing, packaging, labeling, storage, distribution, returns, and destruction of Investigational Medical Products (IMPs) and Non-Investigational Medical Products (NIMPs), ensuring a timely and adequate supply for clinical trials.

We can help.

Manage Drug Supplies from Cradle to Grave for any Clinical Phase(s) 1, 2, 3, or 4

to assist your need to get the product to the market.

MANAGE:

  • Work with your Manufacturing, QA/QC, Stability, and Regulatory Stakeholders

  • Manage Sourcing Comparators and Ancillaries

  • Manage and oversee the Sourcing of Packaging and Labeling

  • Manage Supply Chain

  • Manage Storage and Distribution at all temperature requirements (Room Temp, 2-8C °C, -20 °C, -60 °C, and -120 °C)

SUPPORT:

  • Support Site Accountability and Site Temperature Excursions

  • Site and Study Full Reconciliations, Returns, and Destruction

  • Trial Master Files

  • Support Audit and Regulatory authority Inspection readiness

CREATE:

  • Forecasting

  • Create and manage Site Pharmacy Manuals.

Our expertise involves the role of a Clinical Supplies Consultant and Manager in overseeing drug supply chains across clinical phases, from cradle to grave, to ensure compliance and regulatory readiness, as well as to support various operational aspects, including forecasting, sourcing, and storage.