Clinical Trial Material | Clinical Trial Process & Pharma Manufacturing Work Together to Ensure Success | UPM

Pharmaceutical Manufacturing Clinical Trial Material Supply Chain

Clinical Trial Materials (CTM) or Investigational Medicinal Products (IMP) are used during the trial stage to confirm the effectiveness and safety of drugs for human use.

Running a trial requires not only assembling all of the necessary supplies, it also involves coordinating the schedules of investigators and participants. An inefficient or disrupted clinical trial costs time and money, and can potentially harm patients; therefore, it's imperative to choose a pharmaceutical manufacturing company carefully.

What Is Clinical Trial Supply?

Clinical Trial Supply is the supply of all the pharmaceutical ingredients and materials required for conducting a clinical trial. This includes ancillary supplies such as lab equipment, packaging, latex gloves, etc.

Our Pharma Manufacturing Clinical Materials Capabilities

We provide a successful pharmaceutical manufacturing process that matches your timeline by negotiating the clinical trial supply chain from conception to delivery. We understand that clinical trial label production necessitates greater care to meet the stringent regulatory requirements needed to preserve the integrity of critical drug trials. Our goal is to facilitate a fast trial launch and provide support to ensure unexpected amendments are quickly processed, eliminating costly delays.

Our pharmaceutical manufacturing capabilities offer:

  • 24-hour collection, handling and delivery of biological and infection specimens and samples
  • Assistance with permit applications, import permits, etc. for all clinical trial phases
  • Customs pre-clearance and clearance
  • Temperature-controlled packaging and storage
  • In-house clinical trial material labeling

Compliant Labeling for All Clinical Trial Phases

Most pharma contract manufacturing companies do not offer in-house labeling, yet pharma manufacturing and biotechnology companies require a supply chain that is robust and adaptable to ensure expedient delivery of clinical trial material labels. Labeling onsite offers logistical advantages as well as helping to ensure security and consistency.

Clinical Trial Material Label Formats

Labels for clinical trial phases provide vital drug information to patients. Our team has the capability of printing sheets, rolls and booklets in the following formats:

  • Autoclave
  • Blackout
  • Chemical resistant
  • Cryogenic (cryo)
  • Piggyback
  • Syringe
  • Wrap-around

We print customized clinical trial labels that meet all US regulatory and global pharmaceutical requirements. No matter the size, shape, color or configuration, we provide the labels you need.

UPM's Superior Clinical Trial Material Labeling Abilities

Having the right clinical material labeling partner is more important than ever due to ever-changing clinical trial process regulations, increasing costs and intensified competition. UPM offers state-of-the-art clinical trial material labeling as part of our clinical trial process solutions. Our pharmaceutical drug manufacturing process labeling services include:

  • On-demand label printing
  • Full-color logos and graphic images
  • Advanced inspection software to ensure accuracy
  • High-quality barcode and RFID labels for sample tracking
  • Print variable serialized data from databases
  • Durable labels that are water-resistant and can stand up to chemicals, temperature fluctuations and abrasion
  • Compliance with all local language labeling requirements
  • Confidentiality of data
  • Accuracy

Because we offer these services onsite, we have quicker turnaround times and are able to more easily meet your delivery expectations.

Clinical Trial Material Labeling Regulatory Requirements

As stated in the Code of Federal Regulations Title 21, Section 312.6 of 21CFR312, all pharma contract manufacturing companies must comply with these key drug labeling requirements for new and investigational products:

  • IP packaging of a drug intended for human use must include a label with the following statement: "Caution: New Drug-Limited by Federal (or US) law to investigational use."
  • The label must not include any false or misleading statements and must not represent that the IP is safe or effective for the purposes for which it is being investigated.
  • In addition, the US-ICH-GCPs states that the IP must be coded and labeled in a manner that protects the blinding, if applicable. The IPs must also be packaged in a manner that will prevent contamination or deterioration during transport and storage.

Unmatched Expertise in Pharma Manufacturing

Our team of specialists possess a comprehensive understanding of the pharmaceutical drug manufacturing process, lab label technologies and the importance of clinical trial labeling preciseness and on-time delivery.

They include multidisciplinary clinical trial process experts in pharmaceutical manufacturing R&D, quality control, regulatory support, production, engineering and risk assessment.

We offer a full range of commercial pharmaceutical manufacturing services, including:

You can rely on the expertise of UPM to help you navigate successful clinical trial phases and your long-term manufacturing needs.

CONTACT US

To learn more about how we can partner with you for the pharmaceutical manufacturing process, send us a message or call (423) 989-8000 to speak to a partner.

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