About Clare Plumtree, Principal Consultant

Clare Plumtree stands as the founder and driving force behind Plum Clinical Solutions. A seasoned professional in the biotech and pharmaceutical industry, Clare possesses a wealth of experience in implementing clinical supply chain solutions with rigorous quality and compliance standards, covering all phases of clinical studies across global markets. With PMP® certification, an MBA, and a bachelor’s degree in pharmacy, Clare brings a comprehensive set of qualifications and expertise to every project.

Clare has a proven track record of successfully supporting clients on a global scale. Leveraging her strategic insights, she has led end-to-end provisioning of clinical supplies for numerous Phase 1 to 3 programs within the US, Canada, Europe, Israel, APAC, and more. Clare excels in project managing complex logistics, ensuring regulatory compliance across multiple jurisdictions. Her proficiency extends to problem-solving with creativity, tenacity, and calm determination, making her a valuable asset in navigating the complexities of the clinical trial landscape.

Clare Plumtree, Principal Consultant

“I am passionate, tenacious, resilient and flexible. Critical thinking comes naturally, and I enjoy presenting out-of-the-box solutions to the team for consideration”
– Clare Plumtree, Principal Consultant

Core Competencies

  • Supplies Forecasting
  • Protocol Interpretation
  • Manufacturing and Labeling of Clinical Supplies
  • Clinical Label Design and Manufacture
  • Procurement Assistance
  • Pharmacy Manual
  • Interactive Response Technology (IRT/IXRS) Setup and Oversight
  • Vendor Selection and Oversight
  • Regulatory Sponsor Inspection Audit Preparation
  • TMF Management
  • Supply chain management
  • Distribution and logistics
  • Import and Export Licensing
  • Return and Disposal
  • SOP Development

Specializations: Clare Plumtree boasts extensive knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and FDA guidelines, along with a deep understanding of global regulatory requirements related to clinical supplies. Recently serving successfully as a Subject Matter Expert (SME) for Investigational Medicinal Products (IMP), Interactive Response Technology (IRT), and Trial Master File (TMF) during an FDA Bioresearch Monitoring (BIMO) New Drug Application (NDA) sponsor inspection, Clare is well-versed in ensuring compliance and adherence to industry standards.

Additional Experience: In addition to her core specializations, Clare has experience in central services such as sourcing and setting up central and specialty lab testing, central ECG, central imaging, and electronic Patient-Reported Outcomes (ePRO). Her extensive knowledge extends to Good Practices (GxP), ICH, and FDA, along with global regulatory requirements pertaining to clinical supplies. Clare is well-equipped to assist clients with various aspects, including the creation of Pharmacy Manuals, forms and logs, Standard Operating Procedures (SOPs), and document writing or department infrastructure to ensure GxP compliance.

Personal Attributes: With a solution-oriented mindset, Clare Plumtree approaches challenges with critical thinking, creativity, and tenacity. Her dedication to excellence is intense, and she possesses adaptability and flexibility, excelling in collaborative, cross-functional teams. Clare is passionate about delivering high-quality clinical supply chain services that not only meet but exceed the needs and expectations of clients and patients alike.

“Being a clinical supplies professional is my contribution towards the development of new medicines and therapies that will improve the quality of life for patients in need and their families. This gives me more than enough motivation to deliver the necessary support to clinical sites and Sponsors to provide robust data rapidly and efficiently.”

Clare Plumtree

MORE About Clare

During the onset of the pandemic, I spearheaded changes to the provision of clinical supplies for a pivotal Phase 3 study spanning 23 countries and involving 150 clinical sites. Through strategic collaboration with outsourcing partners, these changes were successfully implemented, resulting in uninterrupted clinical treatment for all subjects.

In a key role supporting a New Drug Application (NDA) and Marketing Authorization Application (MAA) for a pivotal Phase 3 asset, I served as a Subject Matter Expert (SME) for Investigational Medicinal Products (IMP), Interactive Response Technology (IRT), and Trial Master File (TMF) during FDA (BIMO) and EMA sponsor inspections. Notably, there were no findings from these inspections in the specified areas, underscoring the robustness of the implemented processes.

Recognizing a gap in NDA preparations, I volunteered to lead the TMF team during a critical period for the company. This initiative proved instrumental in preparing the TMF for inspection, and there were no findings during the inspection of the TMF. These experiences highlight my proactive approach, leadership capabilities, and successful navigation of challenges in critical situations.

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