COMPLETE, COST-EFFECTIVE SUPPORT FOR YOUR CLINICAL TRIAL

Our project & supply management services are designed to provide comprehensive support for the entire lifecycle of your clinical trial. Our approach is centered around a demand-led supply model that not only reduces waste and costs but also enhances the efficiency and reliability of the clinical supply chain.
Clinical Supply Management

Overview

Optimize your study design and ensure cost-effective approaches for simple protocols to the most complex studies. Minimize waste and drive reliable supply through our international regulatory environment experience, demand simulation and forecasting, and practical issues.

Demand Led Supply: Enable on-demand GMP secondary packaging, labeling and distribution of patient kits to clinical sites based on actual patient need rather than relying upon large static inventories. Clinical sites receive the patient kits they need in a matter of days instead of weeks.

Flexible and Cost-Efficient: By decoupling secondary packaging from the traditional supply model, we achieve a more flexible and cost-efficient supply chain.

Capabilities

  • Global supply chain project lifecycle management, from manufacturing through final accountability and destruction
  • Supply chain planning and optimization services including forecasting
  • Coordination and collaboration with clinical, medical and third-party teams to develop and monitor the clinical supplies plan
  • Integration with IRT (IVR/IWR) systems including co-development of requirements, specifications and monitoring
  • Secure document sharing, real-time shipment tracking, reporting and supply chain visibility
  • Management of inventory levels and expiry data to monitor and control stock at clinical storage facilities, depots and clinical sites
  • Highly potent materials handling and controlled substance management

Demand Led Supply

Efficiencies possible with demand led supply include:

  • Shorterav timeframe for clinical sites to receive patient kits
  • Reduced clinical waste (less than 20%)
  • Drug pooling across protocols
  • Elimination of booklet labels
  • Ability to add/remove countries easily

24/7/365 Case Manager

24/7/365 Support: Our dedicated case manager provides round-the-clock support, orchestrating centralized inventory management and order aggregation at a global level.

Reduced Timelines

Our project and program management experts work with out CMC team to provide the fastest pathway from clinical development to commercial manufacturing. By taking a proactive approach and assessing production considerations early in development, our teams help you reduce risk by working in parallel to address potential roadblocks and ensure robust processes from clinical to launch.

Our integrated solution requires only one transition point on the path from development to commercialization removing the challenges that are often faced when working with multiple providers.

Eliminate the need to cycle through providers, save time with a partner that has capabilities to support development from early to late states

Image showing Renejix Pharma Clinic Trial Phases

Optimize your study design and ensure cost-effective approaches for simple protocols to the most complex studies. Minimize waste and drive reliable supply through our international regulatory environment experience, demand simulation and forecasting, and practical issues.

Demand Led Supply: Enable on-demand GMP secondary packaging, labeling and distribution of patient kits to clinical sites based on actual patient need rather than relying upon large static inventories. Clinical sites receive the patient kits they need in a matter of days instead of weeks.

Flexible and Cost-Efficient: By decoupling secondary packaging from the traditional supply model, we achieve a more flexible and cost-efficient supply chain.

  • Global supply chain project lifecycle management, from manufacturing through final accountability and destruction
  • Supply chain planning and optimization services including forecasting
  • Coordination and collaboration with clinical, medical and third-party teams to develop and monitor the clinical supplies plan
  • Integration with IRT (IVR/IWR) systems including co-development of requirements, specifications and monitoring
  • Secure document sharing, real-time shipment tracking, reporting and supply chain visibility
  • Management of inventory levels and expiry data to monitor and control stock at clinical storage facilities, depots and clinical sites
  • Highly potent materials handling and controlled substance management

Efficiencies possible with demand led supply include:

  • Shorterav timeframe for clinical sites to receive patient kits
  • Reduced clinical waste (less than 20%)
  • Drug pooling across protocols
  • Elimination of booklet labels
  • Ability to add/remove countries easily

24/7/365 Support: Our dedicated case manager provides round-the-clock support, orchestrating centralized inventory management and order aggregation at a global level.

Our project and program management experts work with out CMC team to provide the fastest pathway from clinical development to commercial manufacturing. By taking a proactive approach and assessing production considerations early in development, our teams help you reduce risk by working in parallel to address potential roadblocks and ensure robust processes from clinical to launch.

Our integrated solution requires only one transition point on the path from development to commercialization removing the challenges that are often faced when working with multiple providers.

Eliminate the need to cycle through providers, save time with a partner that has capabilities to support development from early to late states

Image showing Renejix Pharma Clinic Trial Phases

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FAQs

Here are some frequently asked questions about Project & Supply Management

What is Clinical Trials Project & Supply Management?

 Clinical Trials Project & Supply Management encompasses the planning, coordination, and execution of all aspects related to the supply of investigational medicinal products (IMPs) and other materials necessary for clinical trials. This includes manufacturing, packaging, labeling, storage, distribution, and the management of returns and destruction. The goal is to ensure timely delivery of trial supplies, adherence to regulatory requirements, and alignment with trial timelines and budgets.

How do you ensure timely delivery of supplies to global trial sites?

We ensure timely delivery of supplies to global trial sites through meticulous planning, robust supply chain logistics, and real-time monitoring. Our team assesses the specific requirements of each trial site, including import/export regulations and local storage capabilities. We leverage a network of certified couriers and use advanced tracking systems to monitor shipments, address any transit issues promptly, and ensure that supplies arrive as scheduled.

What strategies do you employ to manage supply chain risks in clinical trials?

To manage supply chain risks in clinical trials, we employ several strategies, including:

  • Diversification of suppliers to mitigate the risk of shortages.
  • Strategic stockpiling and safety stock management to buffer against supply disruptions.
  • Advanced planning and forecasting to anticipate demand and adjust production schedules.
  • Continuous monitoring of the supply chain for potential risks and implementing contingency plans as needed.
How do you handle the supply management for multicenter trials?

For multicenter trials, we implement a centralized supply management strategy to ensure consistency and efficiency. This involves coordinating with all trial sites to understand their specific requirements, regulatory considerations, and enrollment timelines. We utilize centralized warehousing and distribution models to streamline logistics and maintain control over the inventory, ensuring that each site receives the necessary supplies according to the trial schedule.

Can you support adaptive trial designs with flexible supply management?

Yes, we can support adaptive trial designs with flexible supply management solutions. Our systems and processes are designed to accommodate changes in trial protocols, including adjustments to dosage, patient cohorts, or study endpoints. We work closely with sponsors to anticipate potential adjustments and implement scalable solutions, such as on-demand packaging and labeling, to quickly adapt to the evolving needs of the trial.

How do you ensure compliance with regulatory requirements for trial supplies?

 We ensure compliance with regulatory requirements for trial supplies through rigorous quality assurance processes, adherence to Good Manufacturing Practices (GMP), and regular audits. Our regulatory affairs team stays updated on global regulations and works closely with sponsors and trial sites to ensure that all documentation, labeling, and shipping procedures meet the specific requirements of each jurisdiction where the trial is conducted.

What measures are in place for the secure storage and handling of trial supplies?

For the secure storage and handling of trial supplies, we employ state-of-the-art facilities with controlled temperature and humidity conditions, as required. Our warehouses are equipped with security systems, access controls, and 24/7 monitoring to protect against unauthorized access and environmental hazards. We also implement strict handling procedures, including segregation of products and thorough training for personnel, to maintain the integrity of trial supplies.

How do you manage the labeling and packaging of clinical trial supplies?

We manage the labeling and packaging of clinical trial supplies by offering customized solutions that meet the specific requirements of each trial, including multi-language labeling, blinding, and patient-centric designs. Our facilities are equipped to handle a range of packaging formats, and our quality control processes ensure that all materials meet the highest standards for accuracy, readability, and compliance with regulatory guidelines.

Can you provide real-time visibility into the supply chain for sponsors?

Yes, we provide real-time visibility into the supply chain for sponsors through our advanced inventory and shipment tracking systems. Sponsors can access up-to-date information on stock levels, shipment status, and site deliveries through a secure online portal. This transparency allows for proactive management of supplies, informed decision-making, and timely responses to any challenges that may arise.

How do you handle the end-of-study reconciliation and destruction of unused supplies?

At the end of a study, we conduct a thorough reconciliation of unused supplies to account for all materials distributed and returned. This process ensures compliance with regulatory requirements and supports the accurate reporting of trial data. Unused supplies are then disposed of in accordance with environmental regulations and documented procedures, including secure destruction of sensitive materials. We provide comprehensive documentation for the reconciliation and destruction process to sponsors for their records.