Managed Access Programs
Managed Access Programs
 

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

Provide the expertise to deliver ethical, compliant, and cost-effective access to unlicensed treatments

Our experience

200
Global Managed Access Programs
90
Countries Shipped to Worldwide
12
Time zones

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

Program Management

Program Management

With extensive experience in program 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 Programs.

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.

Labeling and Packaging Solutions

Labeling and Packaging Solutions

With over 30 years’ experience, Almac is a leader in clinical packaging and labeling – 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

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.

Reporting and Advanced Data Analytics

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

Improved Compliance

Through driving improved compliance at site level and during shipment, we strive to continuously lower risk.

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.”

Managed Access Programs

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Find out more about our Managed Access Programs

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