SupplyPREP℠ Strategic Planning Services
The drug development landscape has changed dramatically in recent years. This is nowhere more evident than in clinical supply management. Companies are now recognizing the strategic importance of clinical supplies in ensuring drug development risks and costs are well understood and anticipated for in advance. Upfront planning has become a critical component to executing a streamlined, efficient and nimble clinical supply chain. As such, clinical supply professionals are now playing a more active role in development and study planning, managing mission critical activities, forecasting and mitigating operational risk.
Fisher Clinical Services has long been committed to helping sponsors of all sizes develop comprehensive clinical supply plans that incorporate the need for flexibility in trial execution with a balanced risk and cost approach. From complete clinical supply plans, to comparator sourcing strategies, distribution strategies and packaging design recommendations, our experts are on hand to meet any of your strategic planning requirements.
Keeping the patient in mind is key to identifying the most optimal packaging configuration for your trial. Our team of project managers in combination with our packaging engineers can assist you in identifying the most suitable packaging for your clinical trial in order to ensure patient safety and compliance. Learn more about packaging here.
Clinical Supply Optimization
Leveraging the expertise of a dedicated supply chain team, proprietary technology tools and an extensive cGMP network, Fisher Clinical Services is able to provide proactive guidance in the development of supply strategies, as well as overarching simulation, forecasting and cost management. This team of professionals can assist you in identifying the most optimal packaging configuration, establishing & verifying IRT setup, forecasting patient clinical supply requirements by country and identifying the regulatory hurdles you will face based upon your current country selection. For more information on our clinical supply services, visit our Clinical Supply Optimization page.
Comparator Sourcing Strategy Development
Sourcing comparator, rescue medication, or co-medication for clinical trials is not merely a purchasing or procurement exercise. Applying a strategic approach, evaluating every sourcing factor and creating a customized plan with multiple options results in an optimal comparator sourcing strategy. For more on comparator sourcing or to view some recent case studies, visit our comparator page.
For strategic planning purposes, our team of QP’s are available to provide advice on your expiry strategy, including the most current conditions required by regulatory authorities.
Clinical Ancillary Management
It’s easy to forget about ancillaries when immersed in the details of a global clinical supply chain. Our dedicated team of clinical ancillary project managers can help you develop a complete ancillary strategy that will ensure your sites are appropriated stocked at time of First Patient In and that you comply with all aspects of the Sunshine Act. To find out more about how you can prepare a clinical ancillary strategy for your trial, visit our clinical ancillary management page.
Clinical Label Strategy
Whether needing to implement an Approved Phrase Library (which has been shown to shorten label cycle times by more than 50 percent) or determining the appropriate label type, text and strategies for your trial, our experienced and dedicated label project management teams can help you build the strategy that will deliver results both long and short term.To learn more about our multiple label options and the Alternative Translation and Label System (ATLAS℠), contact us today or visit our Clinical Label Services page for more information.