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Languages in Global Clinical Trials
This article is in press, and will be published in a future issue of the Drug Information Association Forum (DIA Forum). Copyright to this article is held by the Drug Information Association.

Life Sciences Services

Language Connections is a veteran of the pharmaceutical industry. Our translation teams understand the process, the players, and the regulatory constraints. As demand for multilingual content grows around the world, our pharmaceutical and biotech clients rely on us as a critical part of their international business operations.

Language Connections Certified Translators hold advanced scientific subject-matter degrees and bring direct industry experience to every project. They’re fluent in complex technical and medical terminology in their native languages and in English, and maintain confidentiality in everything they do. Our multi-lingual Project Managers also have years of experience delivering high-value, sensitive projects on time and within budget for global pharmas, biotechnology firms, and CROs.

Separately or within a turnkey project, Language Connections translates:

• Clinical trial protocols
• Patient surveys and informed-consent forms
• Case Report Forms (CRF) and Adverse Event Reports
• IRB/IEC documentation
• Patents and contracts
• Drug packaging and labeling
• Manufacturing SOPs
• Other documents requiring localization, including marketing materials

On your next project, consider the comfort and security of collaborating with a company that understands what is at stake.

Get It Right The First Time

Keen foresight and preparation make all the difference in high-stakes pharmaceutical projects. Our first step is consultation: we listen to your needs, provide input where appropriate based on our experience, and help you adapt your message to fit your target international audience. We anticipate any process issues and explore advance solutions.

With this background information and an overall project plan, we move on to create a detailed project workflow, including schedules for long-term, short-term, or even overnight translations.

We know there is no room for error in matters of health, and we are committed to avoiding missteps the first time through. Your translation team provides you with constant updates and opportunities for feedback at start-up and throughout the project. Working collaboratively, we avoid surprises, sidestep obstacles, and save the time and money associated with rework. We can react quickly to change, scale up for new projects on short notice, and are always ready to meet your needs as they arise.

Quality Assurance

Pharmaceutical work routinely involves high-volume submissions and updates. To handle the volume of your translation work, Language Connections uses proven and stable translation-memory technology to place the value of past translations at your translation team’s fingertips. Our software system allows us to develop and rigorously maintain a specific translation memory for your projects in more than 20 languages, leveraging previous translations and codifying terminology into glossaries for uniform usage from one document to another.

Our knowledge of evolving FDA and EMEA protocols and regulations is another key to our successful life-sciences translation work. You also may choose to appoint an in-house reviewer – an optional quality-control measure welcomed by our translators and editors. In-house review throughout the project ensures that corporate style, tone, and intended message are constantly on point, and that you are in control of the output incrementally, rather than at the end of a project when it is more costly to make changes.

The Result

Our close collaboration with you, the breadth of our pharmaceutical expertise, and our attention to both the detail and nuance of language, pay off for you in confidence. You receive complex materials adeptly translated into the language your market understands, with precisely the message you intended, at the right time, and at the right price. Your international materials communicate effectively while being review-board compliant. Confidence in the process and trust in the product are the reasons our pharmaceutical clients keep coming back to us, project after project. The following case study tells you more.

Case Studies

Parexel International, a leading CRO

Seven years ago, Language Connections began its collaboration with Parexel International, a leading CRO. We began by translating numerous instructional manuals and other supplementary materials complementing Parexel’s Interactive Voice Response Systems.

Later, we developed a comprehensive solution for conducting multilingual over-the-phone medical surveys.

The multi-component process involved providing translation and editing of scripts; auditioning and hiring professional voice talent; recording the scripts in the languages of choice; providing on-demand telephone interpreting; and making available continual and reliable project management around the clock for this open-ended project. We also created standardized terminology in order to ensure consistency and repeatability in all surveys.

Language Connections is providing Parexel with this combination of services on a continual basis, using the same teams of translators and editors to ensure continuity and a stable knowledge base. We have been told that our flexibility and versatility, two qualities that we infuse into all of our work, are especially important to Parexel in this project and in our ongoing relationship.

New Pharmaceutical Client

Early in a new relationship, a pharmaceutical client asked for translation of 2 clinical trials (a total of 45,000 words) into Polish delivered in 8 business days. Impossible?

Not if you work with Language Connections...

Although industry metrics are 2500 words per day per translator, we devised a solution to conquer 45,000 Polish words in just 8 days.

First, we invested one full day in selecting available talent and planning project workflow. We established two dedicated teams in two time zones to work consecutively day after day, including the weekend, using translation-memory tools. This system boosted our output to 5000 words per day, and by using the weekend we had 9 days to finish. We delivered both files on time, translated and formatted, using the appropriate vocabulary and nuance.

Life Sciences Clients

ActivBiotics, Inc.	Interpreting services to facilitate clinical trials concerning Rifalazil, an anti-chlymidial drug.
Angiotech Pharmaceuticals	Translation services for several ICF agreements.
Cline, Davis & Mann	Multilingual copywriting and translation of pharmaceutical brochures to support this large Pharmaceutical advertising agency in its global campaigns.
Concordant Rater Systems	Spanish translations of surveys, helping this consulting firm advise companies on how to improve the efficacy of clinical trials.
Genzyme	Spanish interpreting services for physician conferences and meetings.
InnoCentive	Helping this online community match scientist with Research and Development opportunities by providing multilingual translations of scientific material.
Mannkind	Multi-lingual translation projects, which include clinical trial protocols, investigator brochures, drug labels, medical records, interview questionnaires, advertisements, etc. Mannkind's flagship product is Technosphere, an insulin system in phase 3 clinical trials.
NeoGenesis Pharmaceutical	Japanese translations to support research identifying drug leads from the human genome.
Novelos Therapeutics, Inc.	Extensive multi-lingual translations for this biopharma company, assisting them in conducting worldwide trails for development of drugs to combat cancer and hepatitis.
Parexel International	Years long collaboration providing comprehensive translations and voice recordings for this leading CRO, which with most top pharma companies to bring new drugs to the market with clinical trials management, analysis, regulatory affairs, marketing, etc.
Perceptive Informatics	Translation of medical imaging documents into Latin American Spanish for this subsidiary of Parexel, applying technology to the drug development process.
Pharmacare	Translated pamphlets into Spanish for the country's fourth largest PBM.
PTC Therapeutics	Multilingual translation of technical documents for this biotech company focused on the discovery and development of drugs for genetic disorders, cancer, and infectious disease.