Benefits of an Approved Phrase LibraryFebruary 2011
INTRODUCTION
The challenge of creating labels for investigational drugs is mounting as more countries sign on to participate in clinical trials. Delays in translating and approving clinical labels, a process that averages about 120 business days, can prevent clinical trials from starting on time and threaten to derail development timelines.
The issue boils down to one of process and priorities. Affiliates responsible for translating and approving labels often postpone the time-consuming process to address other pressing matters, causing delays. Since translations are performed manually, inconsistencies and errors frequently result, the potential consequences of which can be more serious than merely having to correct or reprint the label. Label issues are cited by regulators as a major reason for rejecting New Drug Applications (NDA).
A proven solution to the problem of label creation is the use of an Approved Phrase Library, an electronic repository of globally consistent, multi-language terminology that virtually eliminates the need for manual translation. With a single mouse click, the Library automatically translates label text into multiple languages, even populating country-specific information mandated by local regulatory authorities. The Library also permits online approval of label proofs with electronic signatures.
Implementation of an Approved Phrase Library has been shown to shorten label cycle times by more than 50 percent, improving clarity and consistency and reducing the workloads of clinical teams and affiliate staff. The Library is an innovative feature of a web-based project management tool known as ATLASSM (Alternative Translation and Label Approval System).
As a global leader in clinical supply chain management, Fisher Clinical Services is setting the pace for improved translation management with the use of ATLAS. This paper discusses the challenges of translating and approving label text, and how an Approved Phrase Library can reduce label timelines, improve quality, and assure regulatory compliance. ATLAS -- the only system available to address the full spectrum of label development, from text translation and approval through label manufacturing -- is available through Clintrak Clinical Labeling Services LLC, a subsidiary of Fisher Clinical Services.
REASONS FOR BUILDING AN APPROVED PHRASE LIBRARY
The average timeline of 120 business days to generate approved text for a clinical label involves the collective effort of hundreds of individuals across the globe.
The responsibility for translating and approving labels falls on company affiliates, usually subsidiaries or Contract Research Organizations (CRO). The process begins with the drafting of label text in English by a project manager, who routes the template to affiliates.
Affiliates must manually translate the text into their local languages, review it to ensure that it meets local regulatory requirements, and approve it – all before the study can commence. For some large multi-national trials, label text may require translation into dozens of languages. In addition to the time commitment of translating a label, there are often as many as 10 individuals in a single country who must approve it.
Affiliates have heavy workloads. They often relegate label translation to a back burner while they address a host of other priorities, such as manufacturing, distribution and especially patient recruitment. The result: delays, missed deadlines and the possibility that a trial might not begin on time, potentially derailing the development timeline.
The use of an Approved Phrase Library simplifies the process of label translation and approval -- improving clarity and consistency, easing workloads and, importantly, reducing cycle times.
Greater clarity and consistency. There are as many ways to translate the same phrase as there are translators, each of whom has a personal preference. Consider, for example, the phrase “Take one capsule one time per day,” which can also be expressed as “Take one capsule daily,” “Take one capsule once a day,” and even “Take one capsule at any time during the day.” While all are technically correct, the inclusion of different translations of the same instructions in the label is inconsistent.
Clear, consistent language ensures that all patients in a clinical trial receive identical instructions. Repeat use of the same phrase provides the clarity and consistency that are valued by regulatory agencies.
In creating an Approved Phrase Library, standard translations are developed for each commonly used phrase in every language. These approved phrases then automatically populate whenever a label is created and routed to affiliates for translation and approval. Clients have the option of building their own custom repository of standard phrases or accessing the body of standard phrases provided in ATLAS.
Standardization and predictability. By building a library of approved phrases, each affiliate approver is assured of signing off on identical language.
Less interpretation. In some affiliates, individuals responsible for translating label text may create and share a list or spreadsheet of translations for commonly used phrases. The translations may be stored on a desktop or shared drive. Over time, new phrases are added and others revised, reflecting individual interpretations and preferences, and potentially resulting in many different versions of the same phrases. The use of an Approved Phrase Library eliminates the need for local lists/spreadsheets, as well as subjective interpretation.
Decreased risk of errors. When translations are performed manually, human error can occur. It is during the process of retyping and editing that variations are likely to creep into text, and a misspelled, transposed or dropped word can drastically alter the meaning of a word or phrase in some languages. Here are some examples:
Project managers cannot be expected to understand every language and may not recognize translation errors. As a result, labels containing errors could be printed and distributed, a problem that can cost thousands of dollars to correct. The use of an Approved Phrase Library ensures the accuracy of phrases and minimizes the need for translating, retyping or editing.
Flexible revisions. Should the study protocol be revised, as is frequently the case, an Approved Phrase Library provides the flexibility of revising only those portions of the label that require change. The entire label does not have to be translated and approved again.
Reduced workloads. Translating label text is often considered to be the least critical part of affiliates’ jobs. Experience shows that an Approved Phrase Library can halve the time it takes affiliates to translate, review and approve – turning a labor-intensive, time-consuming task into speedy review and approval. By reducing translation and approval time, affiliates can concentrate on other pressing matters.
Curtailed costs. Translating a label often requires the services of a translation company, a cost that is passed on, especially when using CROs. Once a standard phrase library is established and in use the need to hire translation companies diminishes sharply.
Shorter cycle times. An Approved Phrase Library means that much of the work of translating is already done when a label reaches affiliates, shortening the cycle time significantly. Instead of translating 20 phrases, affiliates may have to translate only one or two new phrases. These new phrases can then be standardized and added to the library for future use.
USING AN APPROVED PHRASE LIBRARY
Beginning the label process
The process of creating and routing a clinical label using an Approved Phrase Library begins with establishing an order in the online system. The next step is entering the label attributes, including the size of the study, the study number and other specific details.
Moving on, the contacts to which the label should be sent must be loaded into the system. Once that is done, the required English phrases are selected from a drop-down menu. It isn’t necessary to manually select all of the corresponding translations; the Library automatically populates the phrases in all of the relevant languages, exporting the label copy in the appropriate languages to be sent to the right contacts. In the end, instead of having to translating as many as 500 phrases, it’s likely that fewer than 20 specific phrases will require translation. The process is completely paperless; affiliates can translate, review and approve electronically -- including electronic signatures.
Storing local regulatory requirements
Local regulatory authorities may mandate inclusion of certain phrases in a label, one example of which is “for clinical trial use only”. These phrases are stored in separate areas of the repository. When a particular type of label is selected – such as a small vial, for instance – any additional country-specific phrases will automatically populate.
This feature saves affiliate time and work. It replaces the need to route all-English text and make country approvers responsible for both translating text and adding country-specific phrases. With an Approved Phrase Library, it all comes together at once.
Other key features
· Web-based for convenience: The Library is located on a secure website, requiring only internet access to gain access. Users can pull phrases from the Library, review and approve label copy from anywhere in the world.
· 24/7 access from anywhere: Users can log in virtually anywhere at any time -- in the office, at home or while traveling -- providing maximum flexibility.
· Automatic reminders: Scheduled email triggers remind affiliates about deadlines for translation and approval.
· Most current phrases only: The system ensures that only the current phrases are being used, versus other systems that lack this protection.
· Revisions with change control: The Library captures revisions and phrase updates, while blocking unapproved phrases. In addition to capturing legitimate updates, the system notes the identity and location of the individual who requested the change. This provides version control that is missing when individuals maintain spreadsheets of commonly-used phrases on their desktops.
· Limited access with single administrator: The system permits the administrator to provide users with access only to the areas they need to see – e.g., if responsible for pulling phrases, access to do only that; if an approver, access only for approvals. In addition, the administrator can determine who is authorized to make changes, ensuring the integrity of the Library.
ACCOMMODATING CHANGES OVER TIME:
A major misconception about an Approved Phrase Library is that phrases change over time. Phrases do not change, although preferences for phrases may. While one phrase may be preferred over another, personal preference does not render a different translation of the same phrase incorrect. Clients can customize the library to reflect changing phrase preferences.
Regulatory requirements, on the other hand, can and do change. In addition to storing standard phrases, the Library is a repository for viewing the latest regulatory templates and requirements, which can be updated as often as necessary.
FISHER CASE STUDIES: SPEEDING LABEL APPROVAL
ATLAS and its Approved Phrase Library is making it possible to significantly reduce the label translation and approval timeline – in some cases by more than half -- as it has for two pharmaceutical clients. While it took time to establish a customized global process for these clients, they are reaping the benefits of the process while being able to use the metrics for continuous process improvement.
Case Study 1 -- A large pharmaceutical client was averaging 127 days to finalize label text. The company implemented full ATLAS service, including online ordering, regulatory content, management of approvals and, of course, an Approved Phrase Library. It took about three months to finalize the process, build the custom Library, develop documentation and provide training in advance of the date the system went live.
The effort was well invested: In the initial experience, finalizing label text took 57 days, an immediate savings of 60 days, from the start date.
Case Study #2 -- Another leading pharmaceutical company selected as a pilot a large Phase III clinical trial with clinical sites in 18 countries. Its translation and approval process had been taking about 52 days: o Supply core text -- 1 day o Compile translations -- 5 days o Route documents -- 2 days o Affiliates approve text -- 20 days o Create proofs -- 5 days o Proofs final review -- 2 days o Final proof review -- 15 days o Final quality review -- 2 days
The use of an Approved Phrase Library reduced the timeline by more than 50 percent -- from 52 days to 19 days:
o Supply core text -- 1 day o Compile translations -- 3 days o Create proofs -- 1 day o Route proofs -- 1 day o Affiliates approve proofs -- 8 days o Client quality proof review -- 5 days
SEVEN STEPS FOR USING AN APPROVED PHRASE LIBRARY
1. Be willing to change in order to shorten translation and approval timelines. 2. Assign team leaders to the project, since they are responsible for the label creation process. 3. Track current timelines using current processes to establish a baseline against which to compare and understand where slowdowns are occurring. 4. Determine what you want to accomplish by establishing realistic goals. 5. Create a phrase library that can be enlarged and adapted to meet needs over time. 6. Establish processes to follow before implementing the system. 7. Train users so they understand the use of the system and how to maximize benefits.
ABOUT CLINTRAK CLINICAL LABELING SERVICES
Clintrak Clinical Labeling Services, LLC, is a subsidiary of Fisher Clinical Services (FCS) and the market leader in providing clinical labeling design, production and management services to the pharmaceutical and biopharmaceutical industry from locations within the United States, European Union and Asia.
ABOUT FISHER CLINICAL SERVICES
Fisher Clinical Services provides leading clinical supply chain and project management solutions to pharmaceutical and biotech companies as well as Clinical Research Organizations (CRO) worldwide. Fisher Clinical Services' experience and exposure to large multinational trials and thousands of protocols every year across all therapeutic areas, has allowed us to develop the industry's best practices in clinical supply chain management.
Fisher Clinical Services is a part of the BioPharma Services Division of Thermo Fisher Scientific, the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual revenues of $11 billion, we have more than 30,000 employees and serve over 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings.
For more information please contact: Our Labels Sales Team: USBOH-Label-Sales@fishersci.com |
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