Random Variable Codes
for Clinical Booklet Labels
JH Bertrand will manufacture a booklet label with randomized variable codes printed on the cover* or base label for your open or blinded clinical study. We have a variety of booklet label constructions that will handle all the possible packaging containers you may use to prepare the clinical drug materials such as round vials, square containers, small cartons and bags. This is all done at production speeds faster than the industry average. Aside from what we describe below, see more information on our clinical program from the Markets section of our website.
*We prefer to print codes on the booklet label cover as it offers the best speed and cost advantage. We can also print a single ply pressure sensitive label and apply it later to the cover. Your preference.
YOU SEND US A CSV OR EXCEL FILE PREPARED FOR PRINTING; WE PRINT THE RANDOM VARIABLE CODES FOLLOWING STRICT SOPS AND THEN 100% VERIFY WITH OCR EQUIPMENT. SEE PICTURE BELOW.
- 2D variable barcode.
- Lam to Liner Booklet Label construction for application to round containers.
- 12 paged laminated booklet label with 10 languages.
- Randomized variable code thermal transfer printed on the cover for double blind study.
- Paper and adhesive materials to withstand temperatures below -80 F.
- Produced on rolls for easy manual application or auto application.
JH Bertrand's clinical booklet label program consists of the following advantages:
- Validated Computer Software with audit trail and operator security to control printing of randomized variable codes.
- Vision System with optical character reading (OCR) capability to computer verify that codes are printed in the sequence that was supplied by customer. Ability to verify 2D variable bar codes as well.
- Thermal Transfer and Ink Jet imaging at resolutions up to 600 dpi for sharp graphics.
- SOPs to perform additional post check of the printed codes with ANSI/ASQ sampling plan.
- Strong QA program based on FDA's CFRs.
- Secured storage for selected pre-printed booklet labels (no codes printed) that will be imaged for future lots.
- Variety of booklet label constructions to handle all kinds of packaging such as small round vials, square containers that need to wrap, bags and cartons.
- 200% inspection of proofs. We use a Global Vision System to verify that the customer approved proof matches the offset proof. We also scan finished booklets (before onserting) against customer approved proof.
- Ability to use a variety of codes provided by the customer.
- Materials to withstand conditions below -80 Fahrenheit.
- Unblind sensitivity. JH Bertrand is vigilant regarding quality nuances that could potentially unblind a study such as a repeating mark or subtle changes in the paper shade.
AVT vision system checking 32 paged (2up)
booklet labels before they are slit down to
their finished size. Not pictured is our OCR
scanner as it is proprietary. We welcome
you to come in and see it.
Med ID number is a random variable code
printed on the base label with multilingual
booklet to the side.
Doctors discussing test drug with patient.
Arrow indicates random variable number.
Notice 2D barcode (on upper right side)
which is also variable.