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.
PGLS provides high-quality translation solutions to deliver the best possible experience to limited English proficient (LEP) clinical trial participants.
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.
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.
Multilingual Outreach for Clinical Trials
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.
Translation of 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.
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
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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.
