Clinical Trial Packaging & Labeling Design Services

Strategies to Reduce Program Timelines and Improve the Patient Experience

Because secondary packaging and labeling are the final steps before dispensing or administering an investigational medicinal product (IMP) to a patient, getting this last leg of the clinical trial supply chain right is critical.
 
CalCog helps you to design your clinical secondary packaging and labeling program to improve speed to market, enhance the experience of patients and physicians, manage the complexity of global distribution, ensure regulatory compliance, and address challenges as they arise.
 

CalCog Clinical Packaging & Label Design Services

With the infrastructure, expertise, and quality management systems of a large company and the speed and responsiveness of a small company, CalCog is a key clinical packaging and label design resource for small- and medium-sized pharmaceutical and biotech organizations, as well as clinical research organizations (CROs).

Clinical Packaging Design Capabilities

CalCog’s kit designers and packaging engineers have the diverse experience and expertise to meet the needs of your clinical trial for the entire clinical lifecycle from open-label to double-blind and from Phase I domestic trials to global Phase III trials.

 

  • Extensive packaging design experience in complex trial designs (controlled, randomized, parallel, cross-over, double-dummy)
  • Kit design, ranging from single-visit kits to multi-ancillary component and mixed drug/multi-dose product kits
  • Design of patient leaflets and IFUs (instructions for use)
  • Blinding of clinical trial materials
  • Blister strip wallet card design
  • Metered dose inhaler (MDI) blinding and kit creation, including foil pouch heat sealing
  • In-house randomization services
  • Cold chain packaging design, including ultra-low (-70°C) requirements
  • Schedule I through V controlled substance packaging design

Clinical Label Design & Printing Capabilities

CalCog’s team of experts will help you to select the best type of label for your project. We then put our label design experience and in-house printing capabilities to work to achieve your objectives.

Label Selection & Sourcing

  • Label type selection guidance:
    • Single-panel labels
    • Two-panel tear-off labels
    • Flag or wrap-around labels
    • Global booklet labels
  • Multi-part labels for ease of use at clinical sites, including options for peel-away panels, tear-off flag labels
  • Clinical booklet label sourcing for syringes, vials, cartons, and unusually shaped products

Label Design & Review

  • Design of single-panel labels, global booklet labels, or a combination
  • In-house single-panel label proofing using a 21 CFR Part 11 compliant software solution
  • Ability to create labels with GS1-compliant barcodes
  • Trusted network of approved vendors to provide label text translation and in-country regulatory services

Label Printing

  • In-house capability to print between 1 and 10,000 labels for clinical supply or expanded access programs
  • Labels are printed using fully qualified thermal transfer printers to ensure the label content remains intact in storage ranging from +25°C to -80°C
  • High-resolution desktop label printers offer precision printing in hanzi, kanji, and hanja.
  • Capability to overprint directly onto clinical booklet labels, reducing the cost burden on multi-country studies and providing significantly shorter supply timelines
  • Bespoke requirement capabilities such as printing braille, color company logos, or using alcohol-resistant inks

Our robust secondary packaging and labeling execution capabilities support CalCog’s comprehensive packaging and label design services.

Our Consultative, Collaborative Approach

“Clinical trial start-up is fluid, fast-paced, and complex. Our clients value our experience, expertise, and dedication to navigating the challenges of launching their clinical trials.

We design packaging and labeling solutions based on our client’s specific needs, regardless of their trial’s phase or size. For instance, we do small runs for first-in-human efforts, to 250,000 sealed and labeled wallet cards for a large international study.”

A photo headshot of Neil Armstrong

Neil Armstrong
Global Director of Business Transformation, CalCog

28

Years Supporting Clinical Programs

200+

Active Programs

1.5M+

Units Labeled Annually

6

Continents with Active Programs

Custom Packaging & Label Design Services to Meet the Unique Needs of Every Clinical Trial at Every Phase

Some clinical supply companies prioritize extensive, late-phase studies, and others focus on small, early-phase trials; however, we are experts in all phases of R&D.

Upon securing trial approval, we know that you are likely to need your clinical supplies urgently. Our Concept to Dispatch Within 30 Days program addresses the increased complexity of Phase I and II trials while achieving the required rapid execution.

We also understand the rigors of late-phase programs, including the extensive documentation requirements to support your New Drug Application (NDA).

 

  • Packaging Design by In-house Kit Design Engineers
  • Labeling Strategy Guidance
  • Blinding Options
  • Multiple Dose Dispensing & Kit Configuration Options
  • Randomization File Creation & Maintenance
  • Mock Kit Design

Do You Have Clinical Trial Packaging & Label Design Needs?

CalCog’s full suite of clinical packaging and labeling design capabilities, regulatory expertise, and nimble approaches are here to help.