Managed Access Programmes

 
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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 Programmes (MAPs) are designed to maintain access post-trial or in ‘compassionate use’ cases. Covering a range of programme 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 labelling solutions
  • Optimised end-to-end supply chain management design and execution

Assuring patient access with optimised 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 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

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 serialised level
  • Driving improved compliance at site and during shipment

Our suite of services

Programme Management

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

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

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

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

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

Global Infrastructure and Capabilities

Almac operates a global depot network of GMP facilities.

Next Generation Temperature Management

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

Qualified Person Services

Renowned in the industry, Almac’s QPs possess experience across a wide range of product types and dosage forms.

Client Testimonials

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

Get in touch with an expert today

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