Language Solutions for Life Sciences

Improve Public Health Secure Patient Trust Achieve Compliance Accelerate Development Embrace Diversity Generalize Research Ensure Representation

Ensuring meaningful representation of minorities in clinical trials is critical to public health. Often, those minorities are limited English proficient (LEP). We can help you reach and manage your LEP patient population for your clinical trials.

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PGLS provides high-quality translations in over 200 languages to deliver the best possible experience to limited English proficient (LEP) patients in clinical trials.

Dedicated to navigating the ins and outs of FDA and HIPAA requirements, our highly qualified linguist pool can facilitate highly sensitive patient interactions with accuracy and empathy. Our trusted in-country linguists, subject-matter experts, board-certified medical doctors, and sophisticated translation software bridge language and culture for compassionate, effective communication. Comprehensive project management delivers successful outcomes, protects sensitive medical data, and delivers a consistent patient experience from start to finish.

0 %
of us citizens speak a language other than english at home
0 %
of clinical trials are postponed because of enrollment delays
0 %
of clinical trials fail to achieve patient enrollment goals

Clinical Trials Participation Rates

White White, not Hispanic or Latino Black or African-American Asian Hispanic American Indian & Alaska Native Native Hawaiian or Pacific Islander Two or More Races
U.S. Population %
75.5%
58.9%
13.6%
6.3%
19.1%
1.3%
0.3%
3%
Clinical Trial Participation %
75%**
NR*
8%
6%
11%
NR
NR
NR

Sources: FDA CDER, 2020 Drug Trials Snapshots Report and United States Census Bureau Population Estimates, July 2022.
*NR: Not reported.
** This data does not distinguish Hispanic/Latino individuals who identify as white, which accounts for a significant proportion of LEP patients. And, while an indicator of racial and ethnic diversity, ‘language spoken at home’ is not a demographic data point collected at this time, making it difficult to benchmark your firm’s engagement with LEP patients to industry peers.

Increasing LEP Participation Rates

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Multilingual Outreach

Your outreach plan represents a starting point for establishing trust and credibility with candidates that are limited English proficient (LEP). Per HHS and FDA rules, ensure your patient recruitment strategy is language-accessible. Translations should align with cultural sensitivities regarding doctor-patient interactions, expectations for privacy, and assurances to the level of care they can expect. Partner with PGLS to translate outreach materials into target languages with consideration for varying cultural context(s): websites, landing pages, pamphlets, videos, emails, letters, downloadable PDFs, social media posts, and other informative or marketing content.

Translate Informed Consent Materials

The informed consent process ensures that a clinical trial’s purpose, procedures, potential benefits, and potential risks are completely understood. Two forms of language services must be available to enable informed consent for LEP patients: written translations (developed in advance) and live interpretations for intake, doctor-patient interactions, and other conversation-based communications.

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Our Translation Process for Life Sciences

1. File Preparation

Files prepared for translation

2. Translation

Source documents > Target Language by translators specializing in the specific LS area

3. Editing

Target verified against source by translators specializing in the specific LS area

4. Proofreading

Target verified for comprehensibility

5. Quality Control

Reconciliation of changes

6. Back Translation

Back translation of the translation into source language

7. Quality Assurance

Back translation verified for accuracy against the source document

8. Quality Control

Reconciliation of back translation changes

9. In-Country/Client Review

Review by client or in-country reviewers for comprehensibility

10. Delivery

Delivery of Final Translation & Back Translation

1. File Preparation

Files prepared for translation

2. Translation

Source documents > Target Language by translators specializing in the specific LS area

3. Editing

Target verified against source by translators specializing in the specific LS area

4. Proofreading

Target verified for comprehensibility

5. Quality Control

Reconciliation of changes

6. Back Translation

Back translation of the translation into source language

7. Quality Assurance

Back translation verified for accuracy against the source document

8. Quality Control

Reconciliation of back translation changes

9. In-Country/Client Review

Review by client or in-country reviewers for comprehensibility

10. Delivery

Delivery of Final Translation & Back Translation

1. File Preparation

Files prepared for translation

2. Translation

Source documents > Target Language by translators specializing in the specific LS area

3. Editing

Target verified against source by translators specializing in the specific LS area

4. Proofreading

Target verified for comprehensibility

5. Quality Control

Reconciliation of changes

6. Back Translation

Back translation of the translation into source language

7. Quality Assurance

Back translation verified for accuracy against the source document

8. Quality Control

Reconciliation of back translation changes

9. In-Country/Client Review

Review by client or in-country reviewers for comprehensibility

10. Delivery

Delivery of Final Translation & Back Translation

Get Your Clinical Trials Guide

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Gain Patient Trust & Advance Development.

Our quality assurance processes ensure that translations are accurate, consistent, and meet the highest quality standards, protecting our life sciences clients from potential legal and compliance risks and delivering the best possible experience to LEP patients. To learn more, contact us to explore a partnership opportunity.

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