Frequently asked questions

 

 

Since 1973 thousands of companies and individuals have trusted DTS to get their message across in any language

Security and Data Protection
Do you have a documented process for IT security?

We have made the portal SSL-encrypted, which is the generally accepted standard encryption for secure web site platforms, e-commerce applications, etc., today. As a result, this is a much more secure file-sharing medium than most email systems.  

Periodic password changes are mandatory depending on the system/application and require minimum length, alpha-numeric, and/or security question/answer protocols.    

we have a dedicated server room. This is locked and the servers are not used as employee workstations. The room was designed with proper ventilation in mind. There is an external Sonicwall Firewall and virus protection in continuous real-time mode. There are multiple UPS units, and our IT support area maintains network mapping of the drives.      

Data from DTS servers is backed up to a dedicated appliance from Datto each day on an hourly basis. Daily copies of the servers’ image data are updated to a secure Datto datacenter each night during off-peak hours. Data is rolled up at the offsite datacenter weekly and monthly, and a rolled-up month is kept for a year. Data from the last few days is always available from the local appliance, and older data is available from the offsite datacenter for a rolling year.

 

Do you have firewall and anti-virus protection for your company network?

Yes, there is an external Sonicwall Firewall and virus protection in continuous real-time mode.

Do you have a documented process for data and records backup?
Data from DTS servers is backed up to a dedicated appliance from Datto each day on an hourly basis. Daily copies of the servers’ image data are updated to a secure Datto datacenter each night during off-peak hours. Data is rolled up at the offsite datacenter weekly and monthly, and a rolled-up month is kept for a year. Data from the last few days is always available from the local appliance, and older data is available from the offsite datacenter for a rolling year.
Is access to your computer systems limited to authorized individuals using an ID and password combination?
Yes, access to our computer systems is limited to authorized individuals using an ID and password combination.
Are user IDs limited to only 1 person?
Yes, user IDs are limited to only 1 person.
Do subcontractors and freelancers sign service level agreements that cover document security, security of the transmission of documents, and do they have appropriate backup and recovery facilities?
Yes, they sign service level agreements that cover document security, security of the transmission of documents as well as appropriate backup and recover facilities.
Do you use software that allows freelancers to work on-line on your systems?

Yes, we use software that allows freelancers to work on-line in our systems.

Staff – General Information
Do you subcontract part of the translation service to third parties?
No, we do not subcontract any part of the translation service to third parties.
Do you have signed agreements with each subcontractor or freelancer, delineating responsibilities?
Yes, we have signed agreements with each subcontractor or freelancer, delineating responsibilities.
Does each translator work in his or her native language?
Yes, each translator works in his or her native language.
Which criteria do you use in recruiting and selecting freelancers?

Step 1 — Translator must complete a detailed online application to request partnership with DTS. This application cites all requirements ranging from client confidentiality, Translation Certification permissions, destruction of obsolete equipment/data, and many other categories of quality and performance expectations.

Translator Status is set to PROSPECTIVE.

Step 2 — In-person or telephone interview, which discusses DTS expectations including translation philosophy (see below), areas of clinical specialty, life sciences training and education, review of translator background and resume/CV. Possible reference checking and/or translation sample review at this juncture. All prospective DTS translators must have at minimum five (5) years of proven, full-time work experience as a translator, but in reality, most of our linguists have 10-20 years’ experience and are senior level, accomplished medical-linguists.

Step 3 – Translator must execute and return DTS Onboarding documents which include, among other documents, a DTS NDA, and DTS Philosophy and Approach to Translations.
Step 4 – Translator is assigned a low-level document revision translation or simpler translation, which is edited/QA verified by one of our senior level Language Leaders (There is generally an assigned Language Leader for all of the language directions that we offer.)

Translator Status is then set to ACTIVE.

For translators who achieve ACTIVE status at DTS, their assigned job orders are increasingly graduated to higher levels of difficulty with continued review/scrutiny, with any issues/errors quickly addressed with the translator for correction. We look for any issues to be resolved immediately or the translator is swiftly blocked from being a DTS available resource.

Certain on-going training topics are conducted for translators throughout the year, either on an individual or group basis (within limits of their being contractor status and not employee status). For example, we routinely perform training on how to work on CGIRB documents, how to handle headers and footers, what to do with various font colors, and other “particulars” inherent in CGIRB documents and procedures to help support the Translations Department.

We group and categorize translators according to their particular industry talents, training and education (i.e. some are better suited for handling patient recruitment documents or marketing advertisements than others; some are better suited for handling complex medical/scientific content than others). Roughly speaking, 1/3 of our translators hold MD or Ph.D. degree status (in one of the hard sciences), 1/3 have previous pharma/healthcare career experience (for example, perhaps they worked for a drug company in Europe; perhaps they were a nurse in a clinic or a hospital administrator), and 1/3 are “pure” linguists who learned correct medical/clinical translation procedures by consulting the proper glossaries and resources (i.e. perhaps they have a Master’s Degree in Translation coupled with over 20 years’ experience in medical translation). This 1/3-1/3-1/3 pool is loosely tracked but is in general the pattern we observe of our people.

Are your organization’s staff in-house as well as subcontractors and freelancers under confidentiality restrictions?
Yes, our in-house staff as well as subcontractors and freelancers are under confidentiality restrictions.
Is there a written training program for new and current employees?
Certain on-going training topics are conducted for translators throughout the year, either on an individual or group basis (within limits of their being contractor status and not employee status). For example, we routinely perform training on how to work on CGIRB documents, how to handle headers and footers, what to do with various font colors, and other “particulars” inherent in CGIRB documents and procedures to help support the Translations Department.
Are qualification and training records including CVs and diplomas maintained for all employees?
Yes, qualification and training records including CVs and diplomas are maintained for all employees.
Translation Services
Describe how your organization handles project delays.
In the event of a change of date for translation delivery or other departure from an originally agreed upon service request, this is communicated to the CGIRB contact proactively with as much advance notice as possible, and where possible with more than one solution option presented for discussion. All incidents/deviations are documented in the given service Order, which can be linked to future orders to easily maintain preferences for a given customer.
Can translation requests be directly submitted to a dedicated Project Manager or Team within your organization?
Yes, translation requests can be directly submitted to a dedicated Project Manager
Is there always someone manning the phone? If employees are absent, are their emails read and forwarded?
Yes, there always someone manning the phone.
What types of text do you translate?
  • Patient Informed Consent Forms (ICFs) and Patient Information Leaflets (PILs)
  • Doctor Guides
  • Drug Inserts
  • Patient Guides
  • Patient Questionnaires
  • Regulatory Documents
  • Product Labeling
  • Manuals & Instructions
  • Marketing Materials
  • Website Localization
  • Package Leaflets
  • Software Localization
  • Brand Management
  • Product Approval Packets for Various Regulatory Agencies
  • Patient Information & Brochures
  • IFUs and DFUs
  • Scientific Research Documentation
  • Clinical Research and Medical Reports
  • Regulatory Approval Dossiers
  • Certificates of Conformance
  • E-learning
  • Summary of Product Characteristics
  • Clinical Trial Agreements
  • Clinical Trial Materials
  • Clinical Trial Content
  • Clinical Protocols
  • Frequently Asked Clinical Questions (FAQs)
  • Case Report Forms
  • Patents
  • Scientific Publications>
  • Patient Reported Outcomes (PROs)
  • Scales and Quality of Life (QoL) Instruments>
  • Summaries of Product Characteristics (SmPC)
  • Adverse and Severe Adverse Events
  • Patient Recruitment, Questionnaires, Quality of Life Scales, Diaries and Interpretations
  • Patient and Clinician Education Materials
  • Case Report Forms (CRFs)
  • Training Documentation
  • Clinical Study Protocols
  • Synopses
  • Informed Consent Forms (ICFs)
  • Patents and Patent Applications
  • Chemistry, Manufacturing, and Controls (CMC) Documentation
  • Quality Of Life Scale (QOLs) and other Patient Reported Outcomes (PROs)
  • Packaging and Labeling
  • Investigator Brochures
  • Instructions-For-Use Inserts
  • Medical Device Operation Manuals
  • Instruction and User Guides
  • Product Catalogs
  • Clinical Training Materials
  • Brochures and Web content
  • Informed Consent Forms (ICFs) for Clinical Trials
  • Localization of Medical Device Software
  • Translation of Resource Files
  • Clinical Study Report Forms and Clinical Study Protocols
  • Clinical Trial Recruitment and Retention
  • Case Study Report Forms (CRFs)
  • Physician Letters
  • Site Documentation and Reports
  • Packaging and Labeling
  • Import/Export Permits
  • Preclinical – Phase IV Documentation
  • Operator & Service Manuals
  • Technical & Service Bulletins
  • Human Machine Interfaces & Software
  • Websites, Videos & Mobile Apps
  • Engineering Drawings
  • Content Management Systems
  • Machine Labels & Safety Decals
  • Corporate Communications
  • E-learning Programs & Training Materials
  • International RFQs
  • Product & Parts Catalogs
  • Marketing Materials
  • Product Data Sheets
  • Training and User Manuals
  • Service agreements and contracts
  • Regulatory and compliance documentation
  • Tender letters
  • NDAs
  • Datasheets
  • Trademark and Patent registration
  • Financial reports
  • Marketing materials
  • Fund fact sheets
  • Regulatory prospectuses
  • UCITS
  • KIIDs
  • Patents and Patent Applications
  • Synopses
  • Patents
  • Patient Diaries
  • Product Data Sheets
  • Administrative hearings
  • Court proceedings
  • Annual General Meetings
  • Earnings call
  • General correspondence
  • Notes
  • Public hearings
  • Proceedings at meetings / conferences
  • Sworn statements
  • Pleadings
  • Client tapes
  • Briefs
  • Depositions
  • Examinations under oath
  • Motions
  • Reports
  • Subpoenas
  • Presentations
  • Police interrogations
  • Judgments
  • Interviews
  • Court transcripts
  • Legal examinations
  • Minutes of meeting
  • Mediation briefs
  • Legal pleadings
  • Memorandums
  • Testimonies
  • Telephone conversations
  • Summary of Product Characteristics
  • Instruction and User Guides
  • Website Translation
  • Online Help Content
  • User Manuals
  • GUI and Instructions
  • Marketing Content
  • Systems Engineering
  • Product Data Management
  • Legal Documentation
  • Software Testing (Agile Development)
  • Software Localization
  • User Interface
  • Product Catalogues
  • Labeling
  • Brand Management
  • Multimedia Content
  • Product Launch Briefings
  • App Store & Google Play Materials
  • E-learning
  • Environmental Compliance Content
  • Software Documentation
  • I18n Audits and Code Refactoring
  • Content Management Systems
  • User Manuals

Quality Assurance

Do you have a Quality Management System? How does your company guarantee quality? Your Title Goes Here

Project Overview
• Project Manager reviews the order and related source/reference documents and gathers all
pertinent information in order to effectively assign the project to a qualified linguist(s)
(depending on the number of target languages involved).
• Pertinent information includes: Subject matter of source text and Intended audience
(i.e. Gender, Age, Specific Region).
• Questions are asked of client if preparatory/contextual information is not already known.

Project Preparation for Assignment
• Project Manager prepares the translation assignment complete with all source/reference
documents, specific instructions from client (i.e. formatting requirements), company
background information and websites (for reference), deadline information, and any additional
information that the linguist(s) needs to know in order to complete the project.
• The determination of which translation tools, terminology glossaries, etc. (if any) is made.
• The job order is then assigned to the most qualified translator in our network to perform the
translation based upon experience, education, and subject matter expertise.

Translation
• Translator reviews the source document(s) carefully, asking Project Manager for clarity when
needed.
• Translator produces a target text that conveys as closely as possible the meaning, language
level, and tonality of the source text while adhering to cultural styles and grammar protocol of
the target language.
• Target Text is sent back to Project Manager or uploaded into DTS Portal.
• Project manager prepares the editing packet complete with all source/reference documents,
company background information and websites (for reference), deadline information, and
translated (target) text.
• The packet is then assigned to the most qualified editor in our network to perform the review
based upon experience, education, and subject matter expertise.

Editing
• Editor reviews source document(s) and carefully reads it against the translated document(s) for
accuracy and understanding.
• Editor proofreads translated document checking for errors, typos, mistranslations or omissions.
• Editor makes any necessary changes to translated text (using redline feature in MS Word) and
collaborates with the translator/Project Manager, when necessary, to confirm word choice.
(Note: Edited document is saved separately from translated document.)
• Redlined document is sent back to Project Manager or uploaded into DTS Portal for Final
Proofreading and QA Analysis by the QA Manager of the project.

Final Proofreading and QA Review
• QA Manager reviews edited document(s) and accepts/rejects changes and prepares the final
document for additional QA Analysis.
DTS Quality Assurance Process REV 1‐6‐20
• If applicable, QA Manager runs the target text (bilingual file) through an automated QA check
with QA Distiller and Xbench, to determine if there are any inconsistencies within one or
multiple documents and/or the Translation Memory (TM) tool. Note: In some cases, it may be
necessary to run comparison files to review prior versions of the document(s) and compare
them against the source documents to ensure consistency across all versions of a document.
• QA Manager reviews findings and makes any necessary changes, checking for proper formatting,
correct spelling, grammar, punctuation, capitalization, and sentence structure.
• Where applicable, QA Manager performs check of source file MS Word comparison file (of
previous document version vs. current document version, and/or for site‐specific clinical
documents which may contain customized/specific contents) against the target language
translated comparison file (previous document translation vs. revised translation) to ensure all
changes have been fully and accurately captured in the revised translation.
• Document is then prepped for Final Delivery and delivered to client.

Archiving
• If the translation work partially or fully needs to be added to our Translation Memory data base,
an alignment of the source and target documents is conducted as necessary, and the translation
is thus recorded into our TM tool post‐delivery to the client.
• DTS archives all translation work on its Translation Memory server tool and/or other server
locations, thus removing the order records (including Translation Certificates) out of ‘Active’
status.

How are issues and complaints reported to you and how do you track and manage those issues and complaints?
Generally, incidents are handled swiftly, with same-day response/acknowledgment of the incident intake, and subsequent addressing within one day to one week, depending on the nature and complexity of the request. All incidents/requests are logged and recorded with the original service records and/or general CGIRB document contact records. By and large, there may be a small handful of incidents (less than one per month) in any given year, so there has never been any historical experience of staff overwhelm. Largely this is due to containing the number of DTS resources involved on a given service request for consistency purposes, thus minimizing the chance for error/misunderstanding and maximizing throughput speed and completion without incidents.
How does your firm handle issues and complaints or concerns with regard to quality?
Complaints are an even less frequent event than incidents, so these are addressed swiftly and with follow-up communications to ensure adequate satisfaction to CGIRB and CGIRB clients.
Language Combinations Offered

Expertise Offered

What specialized experience can your organization’s translators offer?

Some kind words about our translation services

R.L.

Regulatory Affairs Mgr.

“DTS did an excellent job with translations for us. I would highly recommend DTS Language Services to any pharma/medical device colleagues. Your company did a cost-effective, and excellent job translating and providing translation certificates.”

C.R.

Associate Project Admin.

“I really appreciate you being to accommodate this request, especially for our biggest client. I am trying to highlight your great customer service and turnaround time on this project to them so that they can see what an amazing vendor you are and want to choose you in the future.”

W.S.

Manager, Reg. Affairs

“You are our preferred provider of translations. We appreciate your timely service and competitive quotes and we are very happy with your service. The DTS customer portal is specifically very nice to work with as it is easy to submit a quote request and track our progress.”

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