Provide the expertise to deliver ethical, compliant, and cost-effective access to unlicensed treatments
Picture the scene. A patient enrolled in your clinical trial with an unmet medical need responds positively to your IMP. Perhaps it has eased pain. Improved their quality of life. Or given more precious time with loved ones.
As the study approaches completion, you consider how best to meet your ethical and regulatory obligations and provide continued, post-trial access to your unlicensed product. Familiarity directs you towards an Open Label Extension trial model. But is it always the correct pathway for you and your patients?
In many scenarios, Managed Access Programs represent a better alternative. As the primary purpose of a Managed Access Program is to provide treatment access, not assess safety and efficacy, they can often prove a more straightforward and cost-effective pathway for sponsors, while still meeting the needs of patients
Our experience
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
Client Testimonials
Why choose Almac for your Managed Access Programs?
When we supply with care, we keep patients at the heart of everything we do. This allows us to deliver the peace of mind that comes with knowing we have every base covered, thanks to our complete supply management approach – from forecasting and production through to storage and distribution.
When we supply with care, we commit to safeguarding timely patient access through optimized global distribution, underpinned by in-depth planning, control tower knowledge, industry leading shipping and monitoring technology, and import services that enable us to successfully navigate customs issues to deliver timely and compliant clearance.
You’re choosing to Supply With Care.
Margaret Radford
Unlicensed Medicine Services Manager
“I Supply With Care because supporting more sponsors to understand the benefits of managed access programs matters to me I Supply With Care because in this industry it isn’t enough to supply without it.
Patients are key stakeholders in every decision we make. Real people with real health conditions putting their faith in our clients to assure timely and compliant supply.”