Clinical Trial Packaging and Labeling Services

cLinical services

Clinical Packaging, Labeling & Distribution

From primary packaging, secondary packaging and labeling to the entire distribution strategy and execution, leverage our global services for seamless delivery directly to sites or patients

Combining services and decades of expertise for a faster, more flexible and reliable experience

Your clinical trial needs a trusted, dedicated partner for your packaging, labeling and distribution that can ensure study success with no missed deadlines and quick study start-up. Lack of options and flexibility with most packaging vendors results in gaps, dissatisfaction, and a cumbersome experience that creates delays.

Myonex’s partnership solves your challenges by being fully adaptable to your unique processes and systems, providing you with reliability – starting with our quick and easy contract and qualification handling. Our streamlined processes and strategically located facilities offer increased capacity and scale, ensuring your trial is prioritized exactly when you need it most. We utilize advanced forecasting and simulation tools to optimize your trial design and supply chain, providing you with everything necessary for a successful clinical trial. Enjoy total control and flexibility, whether you require drug sourcing, ancillaries, or support for decentralized and complex trial designs.

Clinical Packaging and Labeling

A full-service provider for your clinical packaging and labeling needs.

With some of the most experienced packaging experts in the industry, we offer multiple clinical packaging and labeling services to ensure your Investigational Medicinal Products (IMPs), Non-Investigational Products (NIMPs), and ancillary items are trial ready.

Myonex scales with you through to commercial packaging.

Primary Packaging

Clinical Trial Secondary Packaging and Labeling

Secondary Packaging & Labeling

Blinding

Clinical Trial Labeling – Clinical Label Design and Printing – JIT Labeling

Label Design & Printing

Storage, Distribution and Returns

Your clinical trial supply where you need it, when you need it.

With depots over the globe, Myonex can store and distribute your supply to the places your trial requires. Our global logistics team will get your product shipped to sites or Direct to Patient (DtP) or Home Healthcare Providers (HHP) on time, as well as handle returns of unused inventory.

Secure GMP Storage

Cold Storage and Cryo Storage for Clinical Trials

Storage Temperature Ranges

Clinical Trial Distribution Network – Cold Chain Distribution Depots

Distribution / Depot Network

Clinical Trial Supplies Returns Reconciliation and Destruction Services with CoD

Returns, Reconciliation & Destruction

QP Services

Ensure your clinical trial supply is compliant with necessary regulations in the EU and UK.

European Union (EU) and United Kingdom (UK) regulations take precedence when IMPs are manufactured and tested in countries outside of the EU and UK. Myonex Qualified Persons (QPs) have the necessary experience to support your product’s journey to the EU and UK market release following necessary GMP regulations: Batch release and QA release, EU QP Release, UK QP oversight, Manufacturing and Importation Authorization, and Import of IMPs and NIMPs.

Thanks to our authorizations, we provide QP services for a wide range of health products, including chemicals, biologicals, and advanced therapy medicinal products.

Direct to Patient

Safely putting patients first.

Decentralized Clinical Trials (DCT) and hybrid trials require flexibility and reliability to support medication distribution directly to patients. These options provide a more flexible option for patients who then receive medication at home or through a HHP. Direct to Patient (DtP) strategies can support your trial enrollment, decrease dropouts, and provide an option that accommodates patients who have limited access to sites. Myonex’s DtP strategies provide cost-effective and flexible means to medications to those who need it.

DIrect to Patient Solutions
DIrect to Patient Solutions

Temperature controlled distribution and logistics

Patient sample collection

Unused drug returns

Global distribution network

Drug and ancillary sourcing

Expanded Access Programs

Fully-owned US 50-state Pharmacy

CTRx™
Managed Access Programs
Managed Access Programs

A path for patients with severe conditions to get access to non-authorized drugs when no other treatments are available

Compassionate use, expanded access, or early access programs

Packaging and labeling in compliance with local regulations

Regulatory support

Shipment to site or Direct to Patient (DtP) shipping

Cold chain management

Investigational Medicinal Product (IMP) drug compounding

Supply Chain Optimization

Using data, expertise and experience to save time, resources, and cost while mitigating supply risks

Demand planning and forecasting for IMPs, NIMPs, and Ancillaries (including bulk demand planning)
Streamlined internal and external supply chain communication and coordination
Optimized budget planning
Individual supply strategy setup
Inventory management
IRT management, including proposed IRT settings for trigger or resupply
Coordination of packaging schedule
Global project lead
Milestone monitoring
Supply updates
Drug related site feedback handling including temperature excursion handling

CTRx™

A combination of prescription card services, global pharmacy dispensing, and centralized local drug supply in a single solution.

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Clinical Trial Drug Supply - CTRx Clinical Trial Patient Solutions

More Services, One Partner

Drug & Ancillary Sourcing

Everything you need for a successful clinical trial with one partner allowing for the total control and flexibility you need – from drug to ancillary sourcing.

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