Provide the expertise to deliver ethical, compliant, and cost-effective access to unlicensed treatments
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 Programmes represent a better alternative. As the primary purpose of a Managed Access Programme 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
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 labelling solutions
- Optimised end-to-end supply chain management design and execution
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 optimising 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
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 serialised level
- Driving improved compliance at site and during shipment
Our suite of services
Programme Management
With extensive experience in programme and clinical supply chain management, Almac Clinical Services has the qualified people, validated processes and cutting-edge technology to deliver comprehensive MAPs support to sponsors.
Post-Trial Continuity of Care
Almac Clinical Services delivers post-trial continuity of care to patients participating in your Managed Access Programmes.
Subject Matter Experts
Almac’s dedicated Unlicensed Medicines team is comprised of senior subject matter experts with a passion for delivering successful MAP that deliver against ethical and commercial objectives.
Labelling and Packaging Solutions
With over 30 years’ experience, Almac is a leader in clinical packaging and labelling – producing hundreds of thousands of patient kits and labels each year and pioneering novel services.
Storage and Distribution
With in-depth knowledge of import/export, and movement of unlicensed treatments across all global markets, Almac provides strategies to make the best use of clinical supplies and ensure maximum performance of your MAP.
Global Infrastructure and Capabilities
Almac operates a global depot network of GMP facilities.
Next Generation Temperature Management
Almac’s end-to-end regulatory compliant solution gives full visibility of temperature data from any stakeholder within the clinical supply chain; ensuring product quality and integrity from manufacture to patient administration.
Qualified Person Services
Renowned in the industry, Almac’s QPs possess experience across a wide range of product types and dosage forms.
Client Testimonials
"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
Head of Clinical Operations, Large Pharma
Why choose Almac for your Managed Access Programmes?
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 optimised 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.
Reporting and Advanced Data Analytics
The ability to record, report and adjudicate in-transit and site excursions with ease, comprehensive GDP monitoring and excursions tracking
Improved Compliance
Through driving improved compliance at site level and during shipment, we strive to continuously lower risk.
Margaret Radford
Associate Director, Managed Access Services
“I Supply With Care because supporting more sponsors to understand the benefits of managed access programmes 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.”
