U.S. patent application number 13/774659 was filed with the patent office on 2014-08-28 for system and method for labeling trial study materials.
This patent application is currently assigned to Clinical Supplies Management, Inc.. The applicant listed for this patent is Gerald Finken. Invention is credited to Gerald Finken.
Application Number | 20140237950 13/774659 |
Document ID | / |
Family ID | 51386708 |
Filed Date | 2014-08-28 |
United States Patent
Application |
20140237950 |
Kind Code |
A1 |
Finken; Gerald |
August 28, 2014 |
SYSTEM AND METHOD FOR LABELING TRIAL STUDY MATERIALS
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.
Inventors: |
Finken; Gerald; (Fargo,
ND) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Gerald Finken |
Fargo |
ND |
US |
|
|
Assignee: |
Clinical Supplies Management,
Inc.
Fargo
ND
|
Family ID: |
51386708 |
Appl. No.: |
13/774659 |
Filed: |
February 22, 2013 |
Current U.S.
Class: |
53/473 |
Current CPC
Class: |
B65C 9/46 20130101; G16H
10/20 20180101; G09F 3/02 20130101; G16H 20/13 20180101; G09F
2003/0201 20130101 |
Class at
Publication: |
53/473 |
International
Class: |
B65B 5/06 20060101
B65B005/06 |
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.
Description
FIELD OF THE INVENTION
[0001] The present disclosure generally relates to systems and
methods for labeling clinical trial materials on an as-needed or
on-demand basis. Embodiments of the present disclosure may provide
significant cost and time savings over traditional methods used for
labeling study materials.
BACKGROUND
[0002] A clinical trial may include testing a medicament or drug
entity (referred to herein as "drug") in humans in order to
determine its efficacy and safety. Most clinical trials require
that the drug be administered to patients or volunteers
(collectively commonly referred to as "subjects"). Typically trials
require that a test drug be compared to both a placebo, and a known
`standard` or `comparator` drug. Thus, study subjects may be
treated with the study drug(s), a placebo, and/or a comparator drug
in any combination depending upon the design of the study.
[0003] Clinical trials and the coordination thereof are complex,
with the degree of complexity depending in part upon the study
phase. Generally, trials can be divided into four phases, as
described below:
[0004] Phase I: these studies typically involve a relatively small
number of subjects. Some or all of the subjects may know exactly
what treatment they are getting (i.e. an "open study"). Or
alternatively, some or all of the subjects may not know what
treatment they will receive (i.e. a "blinded study").
[0005] Phase II: these are larger studies involving up to several
hundred patients or subjects, and are typically used to determine
the optimum dose for a new drug. The study may incorporate the use
of placebo and comparator treatments and may be `open` or
`blinded`. The number of bottles of drug involved in such studies
may be in the region of dozens to several hundred.
[0006] Phase III: these are typically even larger studies than
Phase II studies, involving hundreds to several thousands of
subjects in most cases. These studies are used to demonstrate the
safety and efficacy of the new drug. These studies may include
placebo and/or comparator treatments and will usually be blinded.
The duration of the study may vary from a few days to several
years, involving from several hundred to hundreds of thousands of
drug containers.
[0007] Phase IV: these are typically post approval
marketing-studies that may vary in size and complexity. They may be
open or blinded and may or may not include comparators. The size
and complexity of these studies may be similar to those for a phase
III study.
[0008] The clinical trial process encompasses a range of different
and complex operations. For example, a trial may involve the
production of the investigational or candidate drug (i.e. synthesis
and formulation of the active ingredient or chemical entity and the
manufacture of the final drug product), packaging, labeling and
dispatch to investigator sites, administration to subjects,
physician assessments and return of biological samples (e.g. blood,
urine samples) for analysis and the return and accountability of
the unused drug.
[0009] The manufacture, packaging and administration/use of drugs
is subject to regulatory control. Thus, for example, the packaging
of drugs or "investigational products" used in clinical trials is
subject to the same regulatory control as is the packaging of any
other pharmaceutical product. For example, currently in Europe, the
EC guide to Good Manufacturing Practice must be followed. In the
United States, various parts of the US Code of Federal Regulations
must be followed, including, but not necessarily limited to--Title
21--Food and Drugs (Part 11--Electronic Records; Part
201--Labeling; Part 312--Investigational New Drug Application; Part
210--Current Good Manufacturing Practice in Manufacturing,
Processing, Packaging or Holding Drugs; General; Part 211--Current
Good Manufacturing Practice for Finished Pharmaceuticals; Part
600--Biologics Products; General; Part 800 General--Medical Devices
and Part 1300--Controlled Substances). Each country typically has
its own complex set of regulations and procedures that apply to
drug labeling for clinical trials that must be followed.
[0010] Generally, clinical trial drug labels may be used to provide
doctors, subjects, and trial sponsors with critical data such as:
batch numbers, directions for us, drug strength or potency,
expiration dates, package numbers, storage requirements, and unique
subject identifiers, for example. In many cases, each clinical
trial label identifies the packaged drug, the study, and the
subject. Each label is unique to the individual subject, in
addition to being trial and country specific. In some cases, labels
may be affixed to a primary container (e.g. the pill bottle, tube,
etc. itself) and one or more secondary containers (e.g. a cardboard
box containing multiple pill bottles, or a kit box containing all
of a subject's individual drug containers for an entire trial or
portion of a trial, or any other secondary container, such as
shipping containers, for example). The FDA and other regulatory
authorities require that every drug be correctly labeled and if
possible permanently adhered to the container. Each country's
labeling laws must also be complied with for each country
participating in the trial. To this end, drug companies typically
submit proposed labels (including labels for drugs to be used with
U.S. subjects as well as labels for drugs to be used with subjects
from one or more other countries, which may need to be provided in
one or more foreign languages) to obtain approvals from quality
assurance and regulatory reviewers in each country.
[0011] Traditional trial study supply packaging and labeling
methods typically include anywhere from dozens to tens of thousands
of trial study supply units being prepared for a given study
protocol or protocols. In a traditional model, all of the labels
for a trial or a significant portion of the trial will be created,
approved, and sometimes printed before the trial even begins. As
previously explained, many trials include the administration of
multiple different treatments, at multiple doses, at multiple sites
in potentially multiple countries to potentially many thousands of
subjects. Accordingly, the regulatory agencies of each country must
approve all of the labels for a given study before a trial begins.
If multiple labels are required for a given unit, for example, a
bottle label and a kit label, each label is batched, printed, and
released separately. Additionally, if a trial study is blinded, for
example, there may be multiple types of labels of different sizes
and information for each blinded dosage strength with each label
group printed and released separately, even though many of the
labels are of the same size and look identical except for a
randomization or identifying number or barcode. In many cases trial
administrators will keep a study label book that contains all of
the approved labels for all of the study sites and countries
participating in the trial. The study drugs are not typically
packaged until all of the labels for all of the expected primary
and secondary containers have been created, approved and sometimes
printed (which may include filling and storing all of the labeled
containers and kits). As can be imagined, this model results in
delay, waste, and inefficiencies. This portion of a clinical trial
(not including drug development) may be the portion of the study
contributing most significantly to study start delays.
[0012] By way of example, if a trial study protocol for a
pharmaceutical product calls for 1,200 patients with each patient
receiving one of two drug dosage strengths or a placebo (i.e.,
1:1:1 or 400 patients on each regimen) and requires each patient to
receive two bottles that are to be placed in a single dispensing
kit, wherein each bottle and each kit is to be labeled with a
clinical label, then the following quantity and label types would
need to be prepared and printed separately according to the
traditional model:
TABLE-US-00001 Label Qty Designation Label type Label dimensions
800 Active A Bottle labels 1'' .times. 2'' 800 Active B Bottle
labels 1'' .times. 2'' 800 Placebo Bottle labels 1'' .times. 2''
400 Active A Kit labels 3'' .times. 4'' 400 Active B Kit labels 3''
.times. 4'' 400 Placebo Kit labels 3'' .times. 4''
[0013] All of these labels would be printed in advance based upon
an approved randomization schedule and released prior to any
labeling operations or production being undertaken. Additionally,
if this study was a multi-national study, a separate printing would
occur for each country. Thus in the example described, if the study
was planned for ten different countries, then a total of sixty
different label types would need to be printed. Numerous
difficulties arise on top of the relatively straightforward
logistics of planning and executing a supply plan for a clinical
trial study, especially in the medical and pharmaceutical fields.
First, in many multi-national studies, where labels must be printed
in different languages, it is a common practice to create booklets
of labels. Study labels are almost always subject to regulatory
approval in every country, territory, or jurisdiction in which the
label is used. This requirement can cause significant delays,
particularly in multi-national studies, as booklet labels cannot be
released for labeling until they are approved in every
jurisdiction. Thus, if booklet labels are used, the entire study
may be delayed due to delays in a single jurisdiction.
Additionally, it is not uncommon to have languages in a booklet
label that are never used due to inaccurate forecasts of countries
participating in a clinical trial.
[0014] Test kits are generally not transferable between test sites
and clinics participating in clinical trials. Accordingly, if a
site is unable to enroll as many subjects as anticipated, a number
of test kits, and in some cases a significant number of test kits
may be wasted, resulting in both loss of time and loss of money. It
is not uncommon for studies to have overages of treatment supplies
ranging from 100 to 300 percent, or more. In an effort to reduce
such waste, some studies are broken into two or more campaigns.
However, studies conducted in campaigns can be more expensive,
because costly steps such as packaging and labeling must be
repeated for each campaign.
[0015] Some medical and pharmaceutical products are subject to
expiration or retesting requirements. Where enrollment is slow, for
example where a study initially intended to take two years extends
to four years; the products in test kits may expire or need to be
retested. If this occurs, the packaged and labeled study drug in
inventory which was never used must be reworked and relabeled.
[0016] Accordingly, a need exists for a labeling method that may
reduce the overall time a trial takes to start and/or complete; is
more efficient; reduces the amount of materials that may be wasted;
is more cost-effective; and/or can relatively easily accommodate
changes that may occur during the planning and execution of a
trial.
BRIEF SUMMARY OF THE INVENTION
[0017] The present method for labeling trial study materials is 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. The method may further
comprise receiving the one or more requests for at least one study
test kit through a computer network, and the method may further
provide a centralized database electronically accessible by the one
or more study supply depots through the computer network. In
addition, the centralized database may contain a randomization
schedule, and the at least two different study supply label types
may be printed according to the randomization schedule. Further, a
first study test kit may contain labels in a first language and a
second study test kit may contain labels in a second language, and
the at least two different study supply label types may include a
first component label, a second component label, and a kit
label.
[0018] In another embodiment, the present method for labeling trial
study materials is 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. The one or more requests for at
least one clinical test kit may be received through a computer
network, and the method may further comprise providing a
centralized database electronically accessible by the one or more
clinical supply depots through the computer network. The
centralized database may contain a randomization schedule, and the
at least two different clinical supply label types may be printed
according to the randomization schedule. Further, a first study
test kit may contain labels in a first language and a second study
test kit may contain labels in a second language. In addition, the
at least two different clinical supply label types may include a
first component label, a second component label, and a kit label.
Finally, in some embodiments, the method may comply with good
manufacturing practices for finished pharmaceuticals.
[0019] In yet another embodiment, the present method for labeling
trial study materials is 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. The central database may be connected to a computer
network, and the centralized database may contain a randomization
schedule. The at least two different clinical supply label types
may be printed according to the randomization schedule. Further, a
first study test kit may contain labels in a first language and a
second study test kit may contain labels in a second language. In
some embodiments, the at least two different clinical supply label
types includes a first component label, a second component label,
and a kit label. In addition, the method complies with good
manufacturing practices for finished pharmaceuticals.
DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 shows a label sheet or continuous feed for use with
the some embodiments of the present disclosure.
[0021] FIG. 2 shows a kit of trial study materials for use with the
some embodiments of the present method for labeling trial study
materials.
[0022] FIG. 3 is a flow chart showing the steps of a method for
labeling trial study materials, according to embodiments of the
present disclosure.
[0023] FIG. 4 is a schematic diagram of a system for implementing
methods the present disclosure in accordance with embodiments of
the present disclosure.
DETAILED DESCRIPTION
[0024] The present disclosure is generally related to efficient,
relatively cost-effective methods and systems for providing labels
for clinical trials on an "as-needed" or "on-demand" basis, while
still complying with applicable regulations and meeting quality
assurance standards. In some embodiments, instead of having all
labels for a study approved and printed prior to the commencement
of the study, labels may be approved and/or printed on an
on-demand, or as-needed basis. Accordingly, in some embodiments,
labels may not be printed and study prescriptions may not be filled
until a specific order is received. As used herein, unless
otherwise specified, the reference to the printing and/or approval
of labels in the clinical trial setting may include labels for use
on drug, or other container that houses a treatment (e.g. a drug,
ointment, drop, injectable device, etc.); labels for use on a test
kit that comprises an individual subject's plurality of containers
of treatments for use by the subject over the entire course of the
clinical trial or some portion of the trial; labels for the
shipment of multiple drug containers and/or multiple drug kits;
and/or labels for use with ancillary supplies related to a
trial.
[0025] As explained herein, multiple embodiments of the present
disclosure are possible that allow for a tailored approach to label
approval and printing for use in a complex and potentially changing
environment such as that of clinical trials.
[0026] FIG. 1 shows one embodiment of a label sheet 30 for use in
connection with embodiments of the present disclosure. The label
sheet 30 may be of any suitable or desired size. In some
embodiments, the label sheet 30 may be of a conventional and
widely-available size, such as U.S. letter size or A4 size. In
other embodiments, the label sheet 30 may be of an unconventional
or custom proprietary size and may be cut from a continuous label
stock feed. The label sheet 30 may be made of any material suitable
for machine printing, such as by a laser printer, ink jet printer,
thermal printer or any other printing technology. The label sheet
30 in some embodiments may be comprised of two or more layers,
including a printable layer 32 and a backing layer 34. In such
embodiments, the printable layer 32 may include an adhesive on the
surface contacting the backing layer 34, and the surface of the
backing layer 34 contacting the printable layer 32 may be coated
with silicone or other material suitable for easily releasing the
adhesive. In some embodiments, the back surface of the backing
layer 34 may also be suitable for printing. In other embodiments,
the label sheet 30 may comprise a single layer, and in such
embodiments, it may be desirable for the back surface of the label
sheet 30 to include an adhesive that can be activated by water or
other solvent.
[0027] The label sheet 30 may include any number of sections
dedicated or designated for labeling components of a test kit. For
example, the label sheet 30 shown in FIG. 1 may be used in a
clinical pharmaceutical trial study. The label sheet 30 may include
drug package labels 36, each of which may include a first panel 36a
and a second panel 36b. In this embodiment, the label sheet 30 also
includes a kit label 38, a container label 40, an instruction panel
42, and a label information panel 44. In some embodiments, the
label portions 36, 38, and 40 of the label sheet 30 may be defined
by die cut or perforated edges 46, for example, for facilitating
removal of each label 36, 38, or 40 from the label sheet 30. The
instructions 48 and label information 50 in some embodiments may
include text, diagrams, and machine-readable codes, such as bar
codes 52, necessary for containing and communicating information to
individuals and machines executing the labeling process. One or
both of these sections 48, 50 may also include, without limitation,
information regarding the particular testing regimen for the
subject, safety information, and blinding information, including a
blinding key, for example. Similarly, each of the drug package
labels 36, kit label 38, and container label 40 may contain
relevant information. For instance, drug package labels 36 may
contain dosing information, drug expiration information, and
emergency information, for example for use in the event that
emergency un-blinding of the study drug is required. Kit label 38
and container label 40 may contain similar information. Each of
labels 36, 38, and 40 may also contain machine-readable codes, such
as bar codes 52, for use by the supply depot or location that may
fill the order and/or study manager(s) for tracking the shipment or
movement of study items, verifying the contents of labeled
containers or kits, and/or any other suitable purpose. Labels or
label sheets may include any combination of the aforementioned
features and/or any other desired feature or information.
[0028] As shown in FIG. 2, a kit 60 may include a plurality of
individual packages or containers 62. In some embodiments the kit
may comprise a particular subject's entire drug regimen for a
trial, or some portion thereof. The particular type of package or
container 62 included in a kit may vary according to the material
it contains. For instance, containers 62 could be vials, tubes,
bundles or other devices for packaging study materials. The kit 60
may also include a packaging instruction sheet, and/or batch record
sheet, and/or an accountability sheet for reconciliation, and/or a
packing list, and/or dispensing instructions for the site 64 that
may accompany the containers 62 that are collectively packaged in a
kit container 66, for example. Individual containers 62 may be
filled according to the instruction panel 42, either before or
after the package label 36 is affixed to the container 62.
Similarly, a kit label 38 and container label 40 may be attached to
the kit container 66. Other kit configurations are also possible.
For example, a site kit may also be used in accordance with some
embodiments, whereby a site kit may be filled with individual
containers of study drugs, for example, or with subject kits for a
plurality of subjects at a particular site.
[0029] A method 100 for labeling trial study materials in
accordance with some embodiments of the present disclosure is now
provided with reference to FIG. 3. The method 100 comprises several
steps, for example, including, but not limited to a planning step
102, an order step 104, and a fulfillment step 106. In other
embodiments additional or different steps may be included in the
method. The planning step 102 may include collecting the
information 102a required for the labeling process 100, including,
for example: information related to the clinical trial design,
goals, and/or any other relevant information; information related
to the study medicament or drug(s) to be administered, including
doses, administration information, type of drug, etc.; drug study
type (i.e. placebo, active test drug, comparator drug, etc.);
regulatory information; country specific information; and/or any
other necessary or desired information. The collected information
may be stored in a database, as shown in FIG. 4 and described
further below. In some cases, some or all of the information may,
or may also be stored in hardcopy form. The information may be
securely stored in some cases by any suitable means, for example,
data stored electronically may be encrypted and/or password
protected, and data stored in hard copy may be housed in a locked
file cabinet or access-card protected room, for example. The
planning step 102a may also include ordering bulk supplies or other
supplies or materials that may be necessary for the labeling
process.
[0030] The planning step 102 of the labeling process 100 may also
include creating and/or receiving label text 102b for each of the
labels to be printed. In some embodiments, the label text may be
drafted, submitted for regulatory approval to the appropriate
authorities or review agencies, and revised as necessary to obtain
approval. In other embodiments, already approved label text may be
received from other entities that have obtained approval for the
labels. In other embodiments, some portion of the approval process
may be performed by outside entities and some portion may be
performed "in-house." Label text may include such relevant
information as dosing and safety information, protocol number,
and/or randomization or serial number, for example. In some cases,
depending on the design of the study and the label at issue, if the
container is to house a blinded drug, the label would not include
any information that would identify the drug to the subject and/or
site and/or principal investigator or trial team (depending on the
study design). The step of creating/receiving label text 102b may
also include creating/receiving label text for each supply kit and
the supply kit component that require a label.
[0031] Labels for supply kits may also need to be reviewed and
approved by one or more agency for compliance with applicable
regulations. Once finalized or approved, label text information may
be stored in the system database and/or hard copy form (in some
cases securely stored). The label text may be associated in the
system with other relevant information for a particular trial
study.
[0032] Finally, the planning step 102 of the labeling process 100
may include planning the label layout 102c. Planning label layout
may include determining the appropriate size for a label sheet,
such that all labels needed for all components of a test kit can be
arranged on a single label sheet (from a single printing), along
with any label sheet information or instructions. In other
embodiments, however, a label sheet may be designed in any desired
manner. Once the label sheet is planned, label stock may be ordered
for use with the printing of the label sheet. In some cases, label
stock may be ordered at other points in the label process 100. All
or any suitable information relevant to the label layout and stock
ordering, including information related to die-cutting dimensions
on a continuous feed, if applicable, may be added to a secure
system database and saved therein (discussed further below).
[0033] The label process 100 may also include the order step 104.
Testing sites or individuals participating in a trial study may
order one or more test kits for use in a particular study, for
example. Accordingly, order information 104a may be received by the
system 10 in any number of ways, including online through a website
or other interactive website response mechanism or via telephone,
or an interactive voice recognition mechanism, or any other
suitable manner. Received order information 104a may be entered
into the system of the present disclosure and associated with
information already stored in the database for the particular study
for which kits have been ordered.
[0034] In some embodiments, the final phase of the method for
labeling trial study materials 100 is the fulfillment step 106. The
fulfillment step 106 may include printing the appropriate labels
106a for the received order (i.e. printing the labels associated in
the system for the test kits that were ordered as per the order
step), verifying that the printed labels 106b are correct (by any
suitable means, including but not limited to visual inspection, or
scanning the labels for comparison against saved data stored in the
system), packaging and labeling 106c the test kits and test kit
components, and shipping 106d the ordered test kits to the proper
location. In some embodiments, additional, fewer, or different
steps may be included in the fulfillment step.
[0035] In some embodiments, the order may be filled by a third
party (i.e. a third party may actually fill the containers with
medicaments as per the instructions for the order and requirements
of the study). In such cases, the order information 104a may be
forwarded to a supply depot/location that is capable of filling the
order. The supply depot may be selected based upon one or more
factors, including, without limitation, language, proximity to the
ordering test site or location, regulatory requirements, and/or
ability to fill the order (i.e. the supply depot having the
relevant bulk supplies).
[0036] Once a supply depot is selected to fill the order, the
appropriate labels may be printed at step 106a on appropriate label
stock. As discussed above, in some embodiments, the labels may be
printed in the faun of label sheets that are specifically designed
to include, for example, all of the labels necessary for an
individual kit. As previously explained, the particular labels to
be printed are determined by the shipment/dispensing request
authorization and a randomization schedule (when applicable)
applied to the particular study being conducted. The randomization
schedule and attendant labels for an order determine the particular
supplies to be packed in the kits that will fulfill the order, and
the label instructions may contain filling and packaging
instructions for the person or persons who fill the order. In some
embodiments, such as those dealing with medical or pharmaceutical
studies, it may be desirable or necessary to separate the different
labels according to the particular drug, dose, or placebo to be
contained in particular kits in order to comply with relevant
regulations pertaining to good manufacturing practices for relevant
goods, such as pharmaceutical products.
[0037] After each label sheet is printed, it may be scanned at step
106b into the system to confirm, and in some cases nearly
instantaneously confirm, that each label on the label sheet has
been printed without any errors. If errors are present, a feedback
loop may be employed to reprint the label at issue or otherwise
troubleshoot an erroneous label. The image of each label may also
be stored in the system database in connection with the particular
study information, in order to maintain an electronic record of
labeling events for future use or reference, for example.
[0038] Once the labels have been verified at step 106b, the
relevant kit components may be dispensed and the kits packaged and
labeled at step 106c. At this packaging and labeling step 106c, a
scanner, for example a hand-held scanner in some embodiments, may
be used to scan the bar codes 52 on each label 36, 38, 40, and 44
to insure that each kit contains the proper materials. Additionally
the containers, drums and/or bags holding the bulk drug, bulk
components and/or devices, etc. used during the packaging operation
may also have a bar code that is associated with each of the bar
codes on each of the components contained in a given kit, to
further ensure that the correct labels are applied to the correct
container, and that the correct drug is contained in the correct
container. In such embodiments, the scanner may be in electronic
communication with the system and verifications may be recorded in
the system database. Once packaging, labeling, and verification are
complete at step 106c, one or more kits 66 prepared to fulfill a
particular order may be shipped to the ordering individual or test
site at step 106d. In embodiments in which the method 100 is used
in connection with clinical studies for pharmaceuticals, it is
preferred, and in some jurisdictions it may be required, that steps
106a through 106c or 106d are performed in close temporal proximity
with each other.
[0039] Accordingly, embodiments of methods of the present
disclosure may advantageously allow for on-demand label printing
and thus supply shipping to sites or subjects as needed. This
method may allow for a significant time savings over traditional
methods of label printing and supply shipment, which generally
requires all of the labels to be created, approved, and printed
prior to any study containers or kits being shipped, or study
commencement. Further, because containers or kits are not filled
and labels are not printed until a specific order is placed for the
container or kit, a potentially enormous reduction in wasted study
materials may result from the use of embodiments of the present
disclosure.
[0040] While embodiments disclosed herein are described with
reference to use in the clinical trial environment, it will be
understood that other embodiments that are within the spirit and
scope of the present disclosure may be used in any other suitable
environments, such as the general pharmaceuticals and device
industry, for example, studies involving animals, labeling of
clinical lab kits or any other suitable field.
[0041] The methods of the present disclosure in some embodiments
may be used in conjunction with a computer-based system. FIG. 4
shows a system 10 for implementing some embodiments of the present
disclosure for labeling trial study materials. The system 10 may
include a computer program, for example, software including
computer executable instructions, hosted on one or more computer
servers 12 or other computer processing device. The server 12 may
also host or be in communication with one or more databases 14. In
some embodiments, the program and server 12 may be centralized and
be in electronic communication with one or more supply
locations/depots, which depots may be located anywhere in the
world. Each supply depot may include a printer 16, a scanner 18,
and in some embodiments a machine for performing die-cuts on-line
for example, each of which may be in electronic communication with
the program and server 12 via a router or modem 19 or other device
for electronically connecting computer network components. In
addition, each supply depot may have a computer terminal 20 or
other computing or input/output device that may also be in
electronic communication with the program and server 12. In some
embodiments, the system 10 may be configured such that the terminal
20 hosts a local program or otherwise mediates the interaction
between the program and server 12 and the printer 16 and scanner 18
located at a particular supply depot. In some embodiments, printer
16 and scanner 18 may be in direct communication with the program
and server 12 without a local terminal 20. Each supply depot may be
set up differently in this regard. In some embodiments, the program
and server 12 are configured to receive input from one or more
interactive website response mechanisms (not shown) or interactive
voice recognition mechanisms (not shown), either of which allow for
system users to provide inputs (not shown) to the program and
server 12, such as placing orders for trial study kits.
[0042] The database 14 may be any database or set of linked or
relational databases. The database 14 may contain any information
relevant to the trial study, including, without limitation, a
randomization schedule; information about the trial study
materials, including bulk supplies, inventory, and ordering
information; kit information, including composition and
specifications; safety and regulatory information; order
information, including purchaser information, order status
information, and shipping information, information for creating
labels, including label content and label text, label stock, label
proofs, label approvals, etc., as well as any desired or useful
software, for example project management software. In some
embodiments a single database 14 may be used in connection with a
single system 10 and program and server 12. In some embodiments, a
particular trial study may use a separate, segregated, or dedicated
database 14.
[0043] While the system 100 has been described in reference to some
exemplary embodiments, these embodiments are not limiting and are
not necessarily exclusive of each other, and it is contemplated
that particular features of various embodiments may be omitted or
combined for use with features of other embodiments while remaining
within the scope of the invention.
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