The value of clinical trial data largely depends on having the investigational and comparator products on hand where and when they are needed. It is important to work with a full-service clinical supply chain partner who can accurately forecast and anticipate the complex interplay of details that can impact product quality, timelines and costs.
ICON’s dedicated Clinical Supplies Management team is experienced in applying cost-effective solutions to even the most complex global studies. Our specialists work in tandem with IRT, like our FLEX ADVANTAGE, to leverage a suite of trial supply management tools to streamline and manage inventory and distribution, enable supply optimisation, and reduce costs and wastage.
Extensive experience and broad expertise
ICON’s Clinical Supplies Management team is experienced in applying cost-effective solutions to even the most complex global studies. We support trials in all phases – from first-in-human (FIH), early phase trials to post-marketing phase 4 surveillance – across a wide variety of therapeutic areas. A dedicated Clinical Supplies Specialist is assigned to the study to provide flexible support through the entire lifecycle of the trial.
Our team members are specially trained in Good Manufacturing Practices (GMP), and on average, have more than 10 years of experience in the pharmaceutical industry, spanning specialties such as:
- Supply chain planning and management
- Clinical project management
- Distribution and inventory management
- Pharmacist expertise
- Labs/chemistry analysis
- Manufacturing and production
- Formulation and development
- Interactive Response Technology (IRT) design
Clinical supply chain planning & forecast management
When we are involved in the earliest stages of project planning, we can provide forecasting and demand planning of drug, placebo and trial supplies. We create a supply chain strategy to show optimal kit configuration and minimise wastage. We work with the sponsor, drug supply vendor and project team to develop a clinical supply management plan ensuring uninterrupted supply.
Our global network of sourcing specialists ensures the right products and documents are on hand to support trial submissions, whether by contracting directly with manufacturers, or purchasing through the open market.
Inventory management and distribution
Through our own depot locations and extensive third-party depot partner network, we offer a full scope of warehousing and global logistics services, ensuring the highest operational standards in the industry. We recommend the best couriers in each region, considering the in-country regulations (e.g., whether a QP release is needed at a depot) and product characteristics.
Regulatory authority inspection support
ICON provide support during regulatory inspection on behalf of the sponsor for anything related to clinical supplies for which we have been contracted – e.g., unblinding documentation which we have developed.
Qualified Person (QP) release
We develop a QP release schedule that coincides with the drug stability pull points as well as study-start-up timelines and site initiation visits.
Accountability – returns, destruction and reconciliation
We ensure accountability for all investigational products (IP) at the end of your study, managing the physical return and destruction of unused product and reconciling supply records.
Direct to patient
As the industry shifts towards a decentralised approach for data capture, the Clinical Supplies Management team are on hand to support the delivery of product kits to patients directly in their homes, including coordinating couriers to execute the strategy.
Cell and Gene Therapy expertise
Working with live cells and tissue requires careful, case-by-case tracking of the chain of custody, chain of condition and chain of identity by the project team.
The product journeys can involve special handling at the sites and are usually time and temperature sensitive. Our cross-functional team of immuno-oncology, cellular and gene therapy experts provides end to end support for these complex studies that test even the most seasoned project teams.
The patient is always at the forefront of our focus and risk mitigation planning.
Whether the IRT is ICON’s FLEX ADVANTAGE or is provided by a specialised vendor, we will consult with the designers to ensure that the system will perform optimally and deliver the best trial outcomes. We can determine the optimal supply and resupply parameters, set expiry date triggers, sign off on the User Requirements Specification (URS), and perform the User Acceptance Testing (UAT) on behalf of the sponsor.