Sharpline Life Sciences

Expert Linguistic Solutions

Sharpline Life Sciences provides comprehensive linguistic services, consulting, and talent management for clinical trials worldwide. We help you deliver accurate, compliant, and culturally adapted content for clinical trials, regulatory submissions and patient safety.

Advance Patient Safety

Ensure the well-being of diverse patient communities by providing vital information in their native language, enhancing safety and improving their health every step of the way.

Expand Your Global Reach

Translate clinical studies, technical manuals, submissions, and marketing materials to position your product confidently in new markets worldwide.

Stay Fully Compliant

Whether it is IFUs, product inserts, or safety documentation, our specialized team helps you meet US, EU, and global regulatory requirements with clear, accurate translations.

Engage More Participants

Make sure every consent form and study document is culturally adapted so that patients truly understand and feel empowered, keeping your clinical trials on track and fully enrolled.

Comprehensive Life Sciences Solutions

Three core service areas designed to accelerate your clinical trials

Linguistic Services

Expert translation and linguistic validation for clinical trial documentation

- Translation & Post-editing

- Proofreading & Back-translation

- Reconciliation Services

- Linguistic Validation

- Comparative Reviews

- Cognitive Debriefings

Consulting Services

Strategic guidance for multilingual clinical trial management

- Multilingual Content Strategy

- Terminology Management

- Style Guide Development

- SOP Creation

- Regulatory Compliance

- Process Optimization

Talent Outsorcing

Comprehensive project management and linguistic talent outsourcing

- Project Management

- Workflow Design

- Quality Assurance

- Vendor Management

- Resource Allocation

Therapeutic Areas We Support

Specialized expertise across major therapeutic domains

Oncology

We support research and treatment protocols in all areas of oncology, including cancer diagnostics, tumor biology, clinical trial documentation, and patient education materials. Our team ensures every translation meets the highest standards of medical accuracy and cultural sensitivity.

Genetics & Gene Therapy

From genetic disorders to cutting-edge gene therapy and genomic medicine, we translate highly technical research, consent forms, and patient-facing documents. This helps you advance personalized treatments with clarity and compliance in every market you serve.

Immunology

Whether you focus on autoimmune conditions, allergy research, or innovative immunotherapies, we deliver translations that clearly convey complex immune system mechanisms to regulators, healthcare providers, and patients.

Neurology

Our expert linguists handle sensitive content related to neurological disorders, brain research, and central nervous system studies. From clinical trial protocols to caregiver instructions, your materials are localized with full respect for cultural and ethical nuances.

Endocrinology

We help you adapt research and educational content on hormonal imbalances, diabetes management, and metabolic disorders. Our translations deliver accurate information to physicians, patients, and regulatory bodies around the world.

Cardiology

Cardiovascular research demands precision at every stage. We translate clinical trial submissions, procedural manuals, and patient instructions for heart disease prevention and treatment, always ensuring consistent messaging that builds trust and compliance.

Ophthalmology

Sharpline Life Sciences provides specialized translations for eye diseases, vision impairment, and ocular treatments. Your information reaches patients and practitioners clearly and meets all local requirements.

Orthopedics

Our team handles orthopedic content covering bone fractures, joint disorders, and musculoskeletal conditions. We ensure that surgical guides, patient rehabilitation instructions, and device manuals are accurately adapted for each target audience.

Pediatrics

When it comes to childhood diseases and developmental conditions, cultural adaptation is essential. We deliver family-friendly translations for pediatric care, treatment plans, and patient support materials that parents and caregivers can easily understand.

Dermatology

From common skin conditions to advanced cosmetic treatments, our translations help you communicate effectively with healthcare professionals and patients. We cover dermatological therapies, research findings, and product safety documentation.

Respiratory Medicine

Whether your focus is lung diseases, asthma, or complex pulmonary research, we ensure that your study materials, patient education content, and regulatory documents are translated with medical precision and cultural awareness.

Infectious Diseases

Timely and accurate communication is critical in the fight against viral, bacterial, or parasitic infections. We help you deliver clear, compliant translations for outbreak responses, treatment protocols, and preventive care information.

Document Types

We Handle

Patient-Facing Content

  • Informed Consent Forms (ICF)

  • Patient Information Brochures

  • Recruitment Campaign Materials

  • Patient Diaries & ePRO

  • Educational Materials

  • Questionnaires & Surveys

Specialist-Facing Content

  • Clinical Trial Protocols

  • Investigator Brochures

  • Summary of Changes

  • Adverse Event Reports

  • Case Report Forms

  • Training Materials

Regulatory Content

  • Clinical Trial Agreements

  • Regulatory Authority Submissions

  • Budget Documentation

  • Ethics Committee Communications

  • Regulatory Notifications

  • Compliance Reports

Case Studies

Success Stories:

Real results from our clinical trial partnerships

Building an In-House Linguistic Department for a CRO

The challenges

A growing CRO needed to establish a fully functional in-house linguistic department to manage multilingual clinical documentation efficiently. They lacked structured processes, trained resources, and a quality framework tailored to meet sponsor and regulatory requirements.

The solution

Sharpline served as a strategic linguistic consultant, designing the department’s structure, defining roles and workflows, training internal staff, and implementing standard operating procedures (SOPs), as well as glossaries and style guides. Clear communication channels and best practices ensured sustainability.

The outcomes

The CRO achieved full operational independence, enabling it to handle critical translations in compliance with local regulations, significantly reduce outsourcing costs, and strengthen its reputation as a reliable partner.

Our added value

Strategic know-how, knowledge transfer, and sustainable in-house capabilities.

Record-Time Translation of Protocol Documentation for Immediate Launch

The challenges

A pharmaceutical sponsor needed to launch a clinical trial on a tight schedule, requiring urgent translation of all patient-facing documents, protocols, and regulatory submissions from English into Spanish. Any delay could jeopardize approval and participant recruitment.

The solution

Sharpline deployed a dedicated team of senior medical linguists and experienced project managers to translate and review over 100 documents in under 15 days. Clear timelines, round-the-clock updates, and parallel quality checks ensured accuracy and speed.

The outcomes

The trial was launched ahead of schedule, securing timely regulatory approval and immediate patient enrollment, protecting the sponsor’s budget and timeline.

Our added value

Exceptional responsiveness, scalable teams, and uncompromising quality under tight deadlines.

Talent Management for a Pharmaceutical Laboratory

The challenges

A mid-sized pharmaceutical laboratory needed to expand its internal team with experienced project managers and highly specialized medical linguists to meet growing demands for multilingual clinical trial content.

The solution

Sharpline became their trusted talent management partner, sourcing, screening, and onboarding top-tier profiles. Rigorous linguistic testing, technical interviews, and customized onboarding ensured a perfect fit for the company’s culture and standards.

The outcomes

The laboratory built a stable, skilled in-house team that reduced turnover, ensured consistent terminology management, and improved project delivery times for multilingual trials.

Our added value

Access to a global network of top talent and seamless onboarding for long-term impact.

Global Language Coverage

Comprehensive linguistic support for international clinical trials

Our network of specialized linguists covers all major language pairs required for global clinical trials, with particular expertise in regional variants and cultural nuances.

US - English

  • US English

  • UK English

  • Canadian English

  • Australian English

ES - Spanish

  • Spain Spanish

  • Mexican Spanish

  • Argentinian Spanish

  • Colombian Spanish

  • LATAM Spanish

BR- Portuguese

  • Brazilian Portuguese

  • European Portuguese

FR - French

  • Canadian French

  • European French

IT - Italian

  • Standard Italian

  • Regional variants

Why Leading Organizations

Choose Sharpline Life Sciences

The competitive advantages that set us apart in clinical trial linguistics

Direct Expert Communication

Work directly with our specialized linguists and project managers. No intermediaries, no miscommunication: just clear, expert guidance throughout your project.

  • Direct access to subject matter experts

  • Real-time project updates

  • Immediate issue resolution

  • Personalized service approach

Regulatory Timeline Adherence

We understand that clinical trial timelines are non-negotiable. Our proven processes ensure on-time delivery without compromising quality.

  • Guaranteed delivery dates

  • Parallel processing workflows

  • Proactive timeline management

  • Emergency response protocols

Emergency Response Capability

Clinical trials can have urgent requirements. Our 24/7 emergency response team ensures critical translations are delivered when you need them.

  • 24/7 emergency support

  • Rapid mobilization protocols

  • Priority resource allocation

  • Same-day delivery options

Direct Global Regulatory Knowledge

Our team stays current with regulatory requirements across all major markets, ensuring your translations meet local compliance standards.

  • Multi-country regulatory expertise

  • Current compliance knowledge

  • Local market insights

  • Regulatory change monitoring

Trusted by Industry Leaders

Join the growing number of organizations that trust Sharpline for their critical clinical trial communications

Number of words translated in the last year:

+ 30 millon

Number of projects delivered in the last year:

+ 5000

Number of professional translators:

+ 100

Number of clients we have served:

+ 120

Testimonials


“Sharpline has been a game-changer for our regulatory operations. Their ability to deliver accurate translations under strict timelines, while maintaining full compliance with international and local requirements, gave us the confidence we needed during complex submissions. Their linguistic quality and attention to regulatory detail are unmatched".

— Director of Regulatory Affairs, Global CRO


“Thanks to Sharpline’s expertise in plain language and cultural adaptation, our study materials finally reached the people they were meant for. Patient comprehension improved significantly, especially among non-English speakers with limited literacy. This had a direct impact on recruitment and retention.”

— Patient Recruitment Coordinator

LogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogoLogo

Office: Av. Hipólito Yrigoyen 1146

Call +54 9 3548 636193

Sharpline Life Sciences, a Sharpline Linguistic Services Company.

Copyright 2025 . All rights reserved