Maintaining ethical, cost-effective, and compliant post-trial access to unlicensed treatments
Clinical trial sponsors, pharmaceutical and biotech companies, have an ethical and regulatory obligation to ensure that patients receive continued, post-trial access to treatments that have been identified as beneficial during a trial.
An alternative mechanism to Open Label Extension (OLE) trials, Managed Access Programs (MAPs) are designed to maintain access post-trial or in ‘compassionate use’ cases. Covering a range of program types, from compassionate use, expanded access, named patient supply, and special access schemes, MAPs are therefore simpler by design. They all have the same end goal, which is to provide a mechanism that enables patients with an unmet medical need to be provided with access to an unlicensed medicine.
Almac Clinical Services’ dedicated Unlicensed Medicine Services group ensures appropriate review and release of unlicensed medicines and successful delivery of MAPs.
Currently managing over 200 global MAPs, and shipping to 80 countries worldwide, Almac provides the global reach, expert people, validated processes, and cutting-edge technology to empower sponsors to maintain ethical, compliant, and cost-effective access to unlicensed treatments.
Features and Benefits
Peace of mind with complete MAP supply management
Almac Clinical Services has the expert people, validated processes, and cutting-edge technology to provide clients with fully comprehensive MAP support.
From forecasting and production through to storage and distribution, Almac’s dedicated Unlicensed Medicines Services ensure successful review and release of unlicensed medicines.
Complete MAP support delivers:
- Full provision of functional support to clients
- Timely and effective engagement with regulatory authorities
- Development of compliant labeling solutions
- Optimized end-to-end supply chain management design and execution
Assuring patient access with optimized global distribution
Distributing unlicensed medicines around the world requires meticulous planning and a vast knowledge and understanding of the nuances of country-specific compliance requirements. Almac Clinical Services safeguards patient access by optimizing global distribution of unlicensed treatments for MAPs.
Assuring patient access with:
- A control tower knowledge of unlicensed medicines, including import/export criteria, courier management, and shipping lane data analysis
- Access to industry-leading shipping and monitoring technology
- Provision of import services and the ability to successfully navigate customs issues to deliver timely and compliant clearance
Lowering risk and driving cost-efficiencies with innovative technology
Upholding the integrity of temperature sensitive biologics and advanced therapeutics is fundamental to ensuring patient safety and effectively controlling costs of MAPs. Almac’s innovative technology and Temperature Services support sponsors to lower risk and drive cost-efficiencies across the complete supply chain.
Lowering risk and driving cost efficiencies by:
- Providing sponsors with automated reporting and advanced analytics
- Enabling sponsors to record, report and adjudicate in-transit and site excursions
- Facilitating comprehensive GDP monitoring
- Allowing sponsors to track excursions at a lot or serialized level
- Driving improved compliance at site and during shipment
Our suite of services
Having Almac Clinical Services as our MAPs partner has provided a stable and reliable approach to our MAP. Their responsiveness and solution orientated approach to issues exceeded our expectations and allowed us to stay on track.Head of Clinical Operations, Large Pharma
Almac has been instrumental in supporting the implementation of our MAP in the EU. Their knowledge on the complex regulations was key to support an efficient review and release of IMP and an uninterrupted supply for our patients.Senior Manager, Clinical Supplies, Large Pharma
Experienced, knowledgeable, responsive and supportive team, with a straight forward process that led to a seamless implementation of a MAP for us the biotech, the sites and associated lead investigators and most of all the patients.Associate Director, CMC and Clinical Supplies, Small Biotech