CCL Clinical Services
Our Full-Service Offer at a Glance
When it comes to secondary packaging services, CCL Clinical is a reliable and trusted provider you can count on. Our pharmaceutical labeling solutions are designed to meet your specific needs and ensure the safe and efficient packaging of your products.
With over 20 years of experience in labeling IMPs, our sites span the USA, Canada, Europe, and Asia, providing CCL Clinical with global reach while maintaining a local presence. Our dedicated team, with extensive knowledge of the clinical trial market‘s demands, forms the backbone of our distinctive operation. CCL Clinical follows a one-stop-shop approach, offering all services related to the labeling of IMPs.
Clinical Modeling
The processing of customer-supplied data for the labeling of IMPs is a
process that requires thoroughly trained personnel and modern software adhering
to the highest quality and safety standards. CCL Clinical is expert in this
process — leave Clinical Modeling to us.
Key Features:
- Randomization: At CCL Clinical, we employ our
proprietary, fully validated software to produce random sequence codes,
block material designs, sequential ranges, and stratifications for
material randomization. With our cutting-edge algorithms, we guarantee
accurate and efficient randomization, tailored to meet your specific
needs. - One-Stop-Shop: We follow a one-stop-shop
approach, offering all services related to the labeling of IMPs: Modeling,
Phrase Library, Label Design, Routing, Variable Data Printing, and, of
course, Randomization.
Why Choose Us:
With over 20 years of experience in labeling IMPs, our sites span the
USA, Canada, Europe, and Asia, providing CCL Clinical with global reach while
maintaining a local presence. Our dedicated team, with extensive knowledge of
the clinical trial market’s demands, forms the backbone of our distinctive
operation. Contact us today.
Clinical Phrase Library
why we have developed an innovative service called the “Clinical Phrase Library.”
With the support of a CMO and a pharmaceutical sponsor company, we have created
this exceptional tool to meet the specific needs of the clinical trial industry.
The Clinical Phrase Library is a tool that provides standardized phrases
in over 30 languages, covering 73 countries. It includes approximately 200
master phrases, all of which have been translated, approved, and successfully
utilized in previous studies. Our Regulatory Service supports you in meeting
all local regulatory requirements.
Key Features:
- Efficient
and Reliable:
CCL Clinical is granted free use of these carefully curated phrases. In
cases where additional phrases are needed, we collaborate with an approved
third-party clinical translation service. This ensures that new
translations are seamlessly integrated into our library, maintaining the
highest standards of accuracy and compliance. - Continuous
Improvement:
Our Phrase Library is continuously updated, with new phrases being added
regularly to ensure it remains comprehensive and up to date. - Regulatory
Service: In
addition to the phrase collection, the Phrase Library service also
includes a Country Specific Requirement List (CSRL). This feature allows
for rules to be defined specifying the content required on labels,
depending on conditions such as the phase of study and packaging type.
These rules stipulate local country regulatory requirements, such as
disposal statements or commercial use information.
In the fast-paced world of clinical trials, precision and compliance are
essential. Whether our Clinical Label Design team receives unprepared or
print-ready data, we transform it into fully compliant clinical labels that
meet the highest industry standards.Joint checklists, specifications, and processes are continuously
analyzed to ensure quality and prevent errors. Our shared objective is to
eliminate mistakes and minimize time spent on corrections.Key Features:
1.
First-Time-Right: Our experienced Clinical Label Design team works quickly and accurately.
CCL Clinical delivers a “First-Time-Right” service that our customers have
relied on for more than 30 years, making us market leaders. - Meeting
Peak Demand: CCL
Clinical provides flexible capacity, offering our customers enhanced
service and helping to shorten timelines. We maintain the necessary human
resources to cover peak demand and serve as a reliable backup. - State-of-the-Art
Service: Our
processes, checklists, and specifications are constantly analyzed and
improved through our Continuous Improvement Process (CIP). Modern offices
and advanced software tools support our daily operations, ensuring a
customized infrastructure that meets our customers’ needs on every
project.
Clinical Routing
In clinical trials, efficient Clinical Routing is essential for keeping
your study on track. At CCL Clinical, we understand the complexities involved
in managing country-specific approvals for individual booklet label pages
across multiple sites, countries, and regulatory environments.
That’s why we offer a Clinical Routing service designed to streamline
the process, reduce delays, and enhance overall study efficiency by creating
multilingual Clinical Booklet Labels that our customers can review and approve.
Key Features:
- Right-on-Time:
Our Clinical
Routing services are tailored to the unique needs of each clinical trial, guaranteeing
that every country-specific approval is secured on time. - Global
Reach: CCL
Clinical’s expertise in international research facilitates smooth routing
across multiple countries and regulatory environments. - Traceability: We provide status overviews in
cooperation with national affiliates and ensure that all trial
documentation is complete, traceable, and compliant, thereby reducing the
risk of errors and delays.
In the realm of clinical trials, Clinical Randomization is critical to
the integrity and success of your study. At CCL Clinical, we specialize in
generating random data tailored to your material and patient requirements using
cutting-edge technology and advanced methodologies. Our Emergency Code Break
Cards are a great example how deep our understanding of our customers’ needs
is.
Key Features:
1.
Material Randomization: CCL Clinical leverages our in-house developed, fully validated software
to generate random sequence codes, blocked material designs, sequential ranges,
and stratifications for material randomizations. Our advanced algorithms guarantees
that your materials are randomized accurately and efficiently.
- Patient
Randomization:
While employing different methodologies, our approach ensures that the
randomization of patients is both reliable and aligned with your study’s
needs. We design randomization specifications within the system to create
the necessary blocking structures and stratifications for diverse patient
populations. - Emergency
Code Break Cards: In case of an emergency, the data must be unblinded. Therefore,
you need Emergency Code Break Cards. Random data will be generated, and
the cards will be designed, printed, and blinded with additional labels.
These labels are made of scratch-off ink. In the event of an emergency,
the scratch-off ink layer is removed, revealing the variable information.
Clinical Variable Data Printing
Boost the performance and reliability of your clinical trials with our
state-of-the-art Clinical Variable Data Printing service. Our service ensures
seamless overprinting of variable data and codes across all product groups,
keeping your labels accurate and up to date. Whether you choose to pre-produce
clinical labels or pull them from stock, our flexible, short-term process is
designed to adapt to the evolving needs of your research.
Key Features:
- Clinical
Variable Data Printing: Our service enables seamless printing of variable data and codes
across all product groups, ensuring up-to-date and accurate labels.
Whether pre-produced or stock-based, our flexible process adapts quickly
to your study’s needs.
- Zero
Tolerance: Our
printing service upholds a zero-error policy, delivering flawless labels
every time. Thanks to rigorous quality assurance, all labels are ready for
immediate use in your facility without additional processing.
3.
Inventory Management: Take advantage of streamlined storage and inventory control supported
by robust tracking and detailed reporting. CCL Clinical ensures complete,
traceable, and fully compliant trial documentation—minimizing risk and avoiding
delays.
- Production
Volumes: Our
capacity allows for the rapid and adaptable production of even large
volumes.
Clinical Modeling
The processing of customer-supplied data for the labeling of IMPs is a process that requires thoroughly trained personnel and modern software adhering to the highest quality and safety standards. CCL Clinical is expert in this process — leave Clinical Modeling to us.
Unified Data Management: At CCL Clinical, we leverage our proprietary, fully validated software to seamlessly manage your clinical data—covering label designs, drug products, lot details, therapy regimens, and packaging hierarchies. Our system ensures complete control over the status of each data element, safeguarding the integrity and consistency of your clinical information across all functions.
Randomization: We can produce random sequence codes, block material designs, sequential ranges, and stratifications for material randomization. With our cutting-edge algorithms, we guarantee accurate and efficient randomization, tailored to meet your specific needs.
Unique Linkage: Our clinical modeling maintains a unique link across all your clinical data within our validated suite of software applications.
One-Stop-Shop: We follow a one-stop-shop approach, offering all services related to the labeling of IMPs: Modeling, Phrase Library, Label Design, Routing, Variable Data Printing, and, of course, Randomization.
Why Choose Us: With over 20 years of experience in labeling IMPs, our sites span the USA, Canada, Europe, and Asia, providing CCL Clinical with global reach while maintaining a local presence. Our dedica-ted team, with extensive knowledge of the clinical trial market‘s demands, forms the backbone of our distinctive operation. Contact us today.
Clinical Phrase Libary
At CCL Clinical, we are committed to revolutionizing our customers’ workflows. That’s why we have developed an innovative service called the “Clinical Phrase Library.” With the support of a CMO and a pharmaceutical sponsor company, we have created this exceptional tool to meet the specific needs of the clinical trial industry.
The Clinical Phrase Library is a tool that provides standardized phrases in over 30 languages, covering 73 countries. It includes approximately 200 master phrases, all of which have been translated, approved, and successfully utilized in previous studies. Our Regulatory Service supports you in meeting all local regulatory requirements.
Efficient and Reliable: CCL Clinical is granted free use of these carefully curated phrases. In cases where additional phrases are needed, we collaborate with an approved third-party clinical translation service. This ensures that new translations are seamlessly integrated into our library, maintaining the highest standards of accuracy and compliance.
Continuous Improvement: Our Phrase Library is continuously updated, with new phrases being added regularly to ensure it remains comprehensive and up to date.
Regulatory Service: In addition to the phrase collection, the Phrase Library service also includes a Country Specific Requirement List (CSRL). This feature allows for rules to be defined specifying the content required on labels, depending on conditions such as the phase of study and packaging type. These rules stipulate local country regulatory requirements, such as disposal statements or commercial use information.
Why Choose Us: Experience the benefits of a streamlined workflow and improved efficiency with the Clinical Phrase Library, which is continuously reviewed and updated. Trust in our expertise to provide you with reliable, ready-to-use phrases for all your clinical trial needs.
Discover how our Clinical Phrase Library can enhance your clinical trials. Contact us today for a consultation and see the difference our expertise can make in the success of your research.
Clinical Label Design
In the fast-paced world of clinical trials, precision and compliance are essential. Whether our Clinical Label Design team receives unprepared or print-ready data, we transform it into fully compliant clinical labels that meet the highest industry standards.
Joint checklists, specifications, and processes are continuously analyzed to ensure quality and prevent errors. Our shared objective is to eliminate mistakes and minimize time spent on corrections.
First-Time-Right: Our experienced Clinical Label Design team works quickly and accurately. As a market leader for more than 30 years, CCL Clinical reliably delivers a “First-Time-Right“ service to our customers.
State-of-the-Art Service: Our processes, checklists, and specifications are constantly analyzed and improved through our Continuous Improvement Process (CIP). Modern offices and advanced software tools support our daily operations, ensuring a customized infrastructure that meets our customers‘ needs on every project.
Why Choose Us: With our Clinical Label Design services, you can reduce the risk of errors, streamline your workflow, and focus on what truly matters – advancing your research.
Let us help you navigate the complexities of clinical trial labeling with ease and confidence. Contact us today to learn how we can support your study with expertly crafted labels that make a difference.
Clinical Routing
In clinical trials, efficient Clinical Routing is essential for keeping your study on track. At CCL Clinical, we understand the complexities involved in managing country-specific approvals for individual booklet label pages across multiple sites, countries, and regulatory environments.
That’s why we offer a Clinical Routing service designed to streamline the process, reduce delays, and enhance overall study efficiency by creating multilingual Clinical Booklet Labels that our customers can review and approve.
Right-on-Time: Our Clinical Routing services are tailored to the unique needs of each clinical
trial, guaranteeing that every country-specific approval is secured on time.
Global Reach: CCL Clinical’s expertise in international research facilitates smooth routing across multiple countries and regulatory environments.
Traceability: We provide status overviews in cooperation with national affiliates and ensure that all trial documentation is complete, traceable, and compliant, thereby reducing the risk of errors and delays.
Why Choose Us: With CCL Clinical‘s Routing service, you can focus on the core aspects of your research, knowing that your labeling is in expert hands. Our team works closely with you to meet your specific study requirements, ensuring that your clinical trial runs smoothly from start to finish.
Elevate the efficiency of your clinical trials with our Clinical Routing service. Contact us today to learn how we can help you navigate this time- and resource-intensive process seamlessly.
Clinical Randomization
In the realm of clinical trials, Clinical Randomization is critical to the integrity and success of your study. At CCL Clinical, we specialize in generating random data tailored to your material and patient requirements using cutting-edge technology and advanced methodologies. Our Emergency Code Break Cards are a great example how deep our understanding of our customers’ needs is.
Material Randomization: CCL Clinical leverages our in-house developed, fully validated
software to generate random sequence codes, blocked material designs, sequential ranges, and stratifications for material randomizations. Our advanced algorithms guarantees that your materials are randomized accurately and efficiently.
Patient Randomization: While employing different methodologies, our approach ensures that the randomization of patients is both reliable and aligned with your study’s needs. We design randomization specifications within the system to create the necessary blocking structures and stratifications for diverse patient populations.
Emergency Code Break Cards: In case of an emergency, the data must be unblinded. Therefore, you need Emergency Code Break Cards. Random data will be generated, and the cards will be designed, printed, and blinded with additional labels. These labels are made of scratch-off ink. In the event of an emergency, the scratch-off ink layer is removed, revealing the variable information.
Why Choose Us: Unlock the true potential of your clinical trials with Clinical Randomization – a cornerstone of rigorous and unbiased research. This process enhances the credibility of your results, allowing
for more accurate comparisons and reliable conclusions.
Embrace randomization to elevate the standard of your clinical trials. Contact us today to achieve results you can trust.
Clinical Labels with Variable Data
Enhance the efficiency and accuracy of your clinical trials with our advanced Clinical Variable Data printing service. Our service provides seamless overprinting of variable data and codes across all product groups, ensuring that your labels are always up to date. With the ability to preproduce clinical labels or pull them from stock, our solution offers the flexibility of a short-term process that adapts to your research needs.
Our Clinical Booklet Label with Variable Data is particularly beneficial for clinical trials where detailed instructions, multiple languages, and regulatory information are required.
Clinical Variable Data Printing: We offer a wide range of customization options to cater to the specific needs of your clinical trial. Whether you need barcodes, QR codes, or Data Matrix codes, we can tailor our Clinical Booklet Labels to meet your requirements.
Zero Tolerance: The Clinical Variable Data printing service maintains zero tolerance for
errors, delivering flawless labels every time. Our high-quality standards ensure that the finished labels are immediately ready for further processing at your site.
Management Inventory: Benefit from streamlined storage and effective management of inventory, backed by comprehensive tracking and detailed reports. CCL Clinical guarantees that all trial documentation is complete, traceable, and compliant, thereby reducing the risk of errors and delays.
Flexible Quantities: Our capacity allows for the rapid and adaptable production of
even large volumes.
Why Choose Us: Experience the flexibility our Clinical Variable Data printing service brings to your study design. Choose our service for an error-free, adaptable, and fully managed labeling solution that drives your trial‘s success. Contact us today.
In which project can we support you?
Our job is to be accurate and cautious right from the start and down to the smallest detail.