At PCI, ensuring life-changing medicines reach those who need it most is our highest priority. As a truly integrated global CDMO, we are manufacturing, packaging and supply chain experts, harnessing our experience and expertise to deliver you a seamless solution with the ultimate aim of improving the lives of patients.
Clinical Supply Management (Supply Management And Readiness Team – SMART) PCI offers customers industry leading expertise in Clinical Supply Project Management. The SMART team consists of experienced Clinical Supply Managers who collectively have hundreds of years of industry experience.
This experienced group are able to provide supply chain expertise, supporting clinical programs across all phases of development.
Clinical Supply Management Services at PCI can supply end-to-end support for clinical trial supplies management. The services provided can be tailored to individual customer needs and may include the following:
Initiate RFQ document writing for outsourcing requirements
Lead the clinical supply cross-functional team
Provide input into protocol development
Create drug supply demand/forecast plans
Contribute to and edit pharmacy manuals
Develop drug supply strategy and timelines
Direct IRT system development and user acceptance testing
Create basic English label text for drug supply per protocol and regulatory requirements
Coordinate packaging schedule with PCI project managers
Manage the IRT and complete lot release activities
Track screening/enrollment and adjust supply strategy as per study needs
Track shipments and manage temperature excursions
Monitor and manage drug supply inventory at sites and depots
Manage trial close-out activities
The services offered by PCI’s clinical SMART team can be customized to meet specific study requirements and can be adapted as the trial or clinical plan progresses. SMART Clinical Supply Managers (CSMs) have the expertise to manage single trials or entire clinical programs. Working with your SMART CSMs will create a detailed RACI to agree roles and responsibilities and agreed levels of collaboration which are required to support the study.
Our highly experienced CSM team are also able to guide the establishment of processes and SOPs when they either don’t exist or are not robust. The team is able to create process flows and author SOPs to fit within your quality system on any clinical supply related aspect such as:
Label text creation and approval
Temperature excursions
Lot release
Recall and recovery
Overall, clinical SMART CSMs integrate into the entire supply chain and are your advocate within PCI.
Review key study assumptions and estimates in order to establish an initial study supply plan
RFQ and relevant documentation prepared for your customer
Thorough evaluation of study requirements and accuracy of the quotation
RFQ submitted to SMART team for peer review, which ensures that you benefit from hundreds years of SMART experience
Access to experienced clinical supply project managers
Tailored customer support on a consultative basis or operational execution of clinical supply management activities, as per agreed requirements
Dedicated experienced project management resource with end-to-end capabilities from protocol development to study close
Provides expertise and capabilities that may not be available internally
Provides resource when required without the need to add internal headcount
SMART First Human Dose (FHD)
PCI offers customers industry leading expertise in Supply Project Management rapidly transitioning a solid oral dose drug from candidate selection to first human dose clinical trials. The SMART FHD team consists of experienced Clinical Supply Managers, Regulatory Scientists, Formulation Scientists, Packaging Technologists, Analytical Chemists and Quality Assurance/QPs who collectively have hundreds of years of industry experience. This experienced group will oversee all drug development preparation activities plus regulatory and clinical trial supply management.
The SMART FHD team at PCI can provide a development path that will be months faster to first human dose clinical trials and years faster to market than traditional formulation development timelines by managing the following:
Develop and manufacture min & max drug-in capsule dosages
Qualify test methods and conduct a bracketed stability protocol including packaging, storage, and testing and provide reports
Manufacture Drug-in-Capsule dosages, bottle, and label for clinic use
Compile all CMC information for regulatory submission
QP release the clinical drug
Manage inventory and distribute the drug for clinical use
Supply project management to organize and oversee all aspect of the development project
It can take up to two years to prepare for your first clinical trial in the US. With PCI’s SMART FHD that time can be reduced to be just a few months.
Rapid Access to Clinical Data
Drug Development Removed from Critical Path
Receive “White Glove” Service
Significant Financial Savings
Time & expense of multiple development activities eliminated
Flexibility of Supply through Phase 2a (& possible beyond)
