SYSTEM AND METHOD FOR LABELING TRIAL STUDY MATERIALS

• US 20140237950A1
• Filed: 02/22/2013
• Published: 08/28/2014
• Est. Priority Date: 02/22/2013
• Status: Abandoned Application

• Current Assignee: Clinical Supplies Management, Inc. (Clinigen Group PLC)
• Original Assignee: Clinical Supplies Management, Inc. (Clinigen Group PLC)
• Inventors: Finken, Gerald
• Application Number:
  US13/774,659
• Publication Number:
  US 20140237950A1
• Time in Patent Office: Days
• US Class Current: 53/473
• CPC Class Codes: B65C 9/46 Applying date marks, code marks, or the like, to the label during labelling manually-controlled or operable apparatus having printing equipment B65C11/02; ticket printing and issuing G07B1/00 ; apparatus for ticket validating or cancelling G07B11/00
• CPC Class Codes: G09F 2003/0201 Label sheets intended to be introduced in a printer, e.g. laser printer
• CPC Class Codes: G09F 3/02 Forms or constructions layered products B32B
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/13 delivered from dispensers

Abstract

The present disclosure relates to methods and systems for labeling trial study materials. The method, in some embodiments comprises the steps of providing bulk supplies to one or more study supply depots, receiving one or more requests for at least one study test kit at the one or more study supply depots, packaging the bulk supplies into one or more study test kit components, printing at least two different study supply label types on a single label sheet, affixing the at least two different study supply label types to the study test kit components, packaging the study test kit components into at least one study test kit; and shipping the at least one study test kit to a trial site.

Claims

1. A method for preparing materials for blinded studies comprising the steps of:

providing bulk supplies to one or more study supply depots;

receiving one or more requests for at least one study test kit at the one or more study supply depots;

packaging the bulk supplies into one or more study test kit components;

printing at least two different study supply label types on a single label sheet;

affixing the at least two different study supply label types to the study test kit components;

packaging the study test kit components into at least one study test kit; and

shipping the at least one study test kit to a trial site.

2. The method of claim 1, further comprising:

wherein the one or more requests for at least one study test kit are received through a computer network.

3. The method of claim 2, further comprising:

providing a centralized database electronically accessible by the one or more study supply depots through the computer network.

4. The method of claim 3, further comprising:

wherein the centralized database contains a randomization schedule.

5. The method of claim 4, further comprising:

wherein the at least two different study supply label types are printed according to the randomization schedule.

6. The method of claim 1, further comprising:

wherein a first study test kit contains labels in a first language and a second study test kit contains labels in a second language.

7. The method of claim 1, further comprising:

wherein the at least two different study supply label types includes a first component label, a second component label, and a kit label.

8. A method for preparing materials for clinical medical trials comprising the steps of:

providing bulk supplies to one or more clinical supply depots;

receiving one or more requests for at least one clinical test kit at the one or more clinical supply depots;

packaging the bulk supplies into one or more clinical test kit components;

printing at least two different clinical supply label types at the time of packaging;

affixing the at least two different clinical supply label types to the clinical test kit components;

packaging the clinical test kit components into at least one clinical test kit; and

shipping the at least one clinical test kit to a trial site.

9. The method of claim 8, further comprising:

wherein the one or more requests for at least one clinical test kit are received through a computer network.

10. The method of claim 9, further comprising:

providing a centralized database electronically accessible by the one or more clinical supply depots through the computer network.

11. The method of claim 10, further comprising:

wherein the centralized database contains a randomization schedule.

12. The method of claim 11, further comprising:

wherein the at least two different clinical supply label types are printed according to the randomization schedule.

13. The method of claim 8, further comprising:

wherein a first study test kit contains labels in a first language and a second study test kit contains labels in a second language.

14. The method of claim 8, further comprising:

wherein the at least two different clinical supply label types include a first component label, a second component label, and a kit label.

15. The method of claim 8, further comprising:

wherein the method complies with good manufacturing practices for finished pharmaceuticals.

16. A method for preparing materials for clinical medical trials comprising the steps of:

providing clinical trial label data to a central database;

creating label text for at least two different clinical supply label types from the clinical trial label data;

obtaining regulatory approval for the label text;

printing the at least two different clinical supply label types on a single label sheet;

verifying the accuracy of the at least two different clinical supply label types; and

affixing the at least two different clinical supply label types to clinical test kit components.

17. The method of claim 16, further comprising:

wherein the central database is connected to a computer network.

18. The method of claim 16, further comprising:

wherein the centralized database contains a randomization schedule.

19. The method of claim 18, further comprising:

wherein the at least two different clinical supply label types are printed according to the randomization schedule.

20. The method of claim 16, further comprising:

wherein a first study test kit contains labels in a first language and a second study test kit contains labels in a second language.

21. The method of claim 16, further comprising:

wherein the at least two different clinical supply label types include a first component label, a second component label, and a kit label.

22. The method of claim 16, further comprising:

wherein the method complies with good manufacturing practices for finished pharmaceuticals.