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Why Fragmented Localization Workflows Cause Delays

Traditional clinical localization models often rely on disconnected processes managed by separate teams or vendors. This fragmentation leads to avoidable inefficiencies and risks at critical stages of clinical trial execution.

  • Inconsistent handoffs across vendors disrupt quality control and introduce versioning issues.
  • Sequential review cycles slow down timelines, especially when linguistic validation, in-context QA, and regulatory review are handled in isolation.
  • Disjointed validation processes increase the likelihood of noncompliance with ISPOR, FDA, or EMA requirements.
  • Late-stage quality assurance often reveals rendering or scale issues that require retranslation, delaying study launches.

These challenges are especially pronounced in high-volume, multi-language deployments common in eCOA and PRO instrument localization.

Sesen addresses these pain points with a fully integrated workflow designed specifically for clinical research. Our approach eliminates silos, accelerates turnaround times, and ensures alignment across linguistic, technical, and regulatory requirements.

One Workflow, Three Critical Functions Combined

Sesen’s integrated clinical localization workflow consolidates three essential components—linguistic validation, in-context eCOA quality assurance, and regulatory labeling review—into a unified process that eliminates inefficiencies and accelerates multilingual study readiness. Designed specifically for life sciences and digital health platforms, this workflow ensures linguistic accuracy, technical functionality, and regulatory compliance from the outset.

This consolidated model enables concurrent reviews, reduces handoffs, and delivers validated, interface-ready translations optimized for global clinical use.

Sesen begins with rigorous linguistic validation aligned with ISPOR and EMA standards for PRO, ObsRO, and ClinRO instruments.

  • Includes forward translation, reconciliation, and back translation workflows
  • Conducts cognitive debriefing with target-language patients or users to ensure clarity and cultural relevance
  • Performs harmonization across languages to maintain consistency in meaning
  • Led by professional native linguists with deep subject-matter expertise in therapeutic areas and eCOA instruments

In parallel with validation, Sesen performs UI-based quality checks within the digital environment where the content will be deployed.

  • Uses platform-provided access or annotated screenshots for in-context review
  • Identifies issues such as truncation, incorrect line breaks, visual misalignment, and misrendered scales
  • Verifies that translations preserve clarity, readability, and functional layout across devices and languages
  • Ensures that user-facing content performs reliably within eCOA applications and supports patient usability

To further strengthen content quality and compliance, Sesen applies a final layer of regulatory and labeling review.

  • Cross-references translated terms against approved Instructions for Use (IFUs), Summary of Product Characteristics (SmPC), or Trial Forms and Labels (TFLs)
  • Applies phrasing conventions consistent with regulatory authorities including FDA, EMA, and PMDA
  • Especially beneficial for hybrid eCOA modules that draw from product labeling or submission documents
  • Delivers submission-ready language that aligns with sponsor expectations and global regulatory frameworks

Together, these three functions form a harmonized workflow that reduces delays, enhances clinical data quality, and supports rapid study deployment across international markets.

Accelerating eCOA Localization with Integrated Validation and QA

Accelerating eCOA Localization with Integrated Validation and QA

Sesen’s integrated localization workflow is engineered to improve operational efficiency and reduce risk across the clinical trial lifecycle. By consolidating linguistic validation, in-context eCOA QA, and regulatory review into a single process, we help sponsors and eClinical providers deploy multilingual studies faster, with greater accuracy and compliance.

This unified approach offers measurable advantages at every stage of global study execution.

Consolidating multiple services under one workflow streamlines project management and eliminates communication gaps across vendors, regulatory reviewers, and localization teams.

Parallel processing of validation, UI QA, and regulatory review eliminates downstream bottlenecks and significantly shortens study localization timelines.

Each translation is validated, context-verified, and reviewed against regulatory conventions to reduce the likelihood of delays due to noncompliance or rework.

In-context QA ensures that translated items render correctly within the digital platform, preserving usability and supporting immediate deployment.

By accelerating go-to-market timelines and improving submission quality, this workflow enhances sponsor satisfaction and strengthens the role of clinical technology providers as strategic partners.

Sesen’s integrated process is designed for scalability, precision, and regulatory alignment—giving global clinical teams the tools to succeed in today’s fast-paced, multilingual trial environments.

Built for eCOA, DCT, and Clinical Tech Leaders

Built for eCOA, DCT, and Clinical Tech Leaders

Sesen’s integrated localization workflow was designed specifically to support the needs of eClinical technology providers, decentralized clinical trial platforms, and digital health teams responsible for delivering high-quality, multilingual instruments across global markets. Our process addresses long-standing bottlenecks that delay trial readiness and introduce risk into regulatory-facing deliverables.

Common Challenges We Solve

Clinical tech providers often manage translation, validation, platform QA, and regulatory review across multiple disconnected workflows. This fragmentation leads to:

  • Inconsistent handoffs between localization vendors, internal QA teams, and regulatory stakeholders
  • Rework caused by late discovery of UI rendering issues, noncompliant phrasing, or formatting errors
  • Misalignment between translated clinical outcome assessments and how content appears in-app or across devices

These issues compound as the number of target languages and study regions increases, placing pressure on internal teams and slowing trial deployment.

Strategic Value Delivered

By unifying linguistic validation, in-context eCOA QA, and regulatory review into a single workflow, Sesen enables clinical technology teams to operate more efficiently and deliver more value to their sponsors.

  • Accelerates study launch timelines across multiple languages by eliminating sequential dependencies
  • Reduces internal coordination efforts, allowing teams to focus on innovation and platform delivery
  • Improves global submission quality by aligning language, format, and function from the outset
  • Strengthens client relationships by ensuring translated instruments are ready for use, both clinically and technically

This integrated model positions clinical tech providers as proactive partners in global study success, rather than reactive service coordinators.

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Designed for the Full Clinical Content Ecosystem

Designed for the Full Clinical Content Ecosystem

Sesen’s integrated localization workflow supports a broad range of stakeholders involved in planning, executing, and overseeing multilingual clinical studies. Whether managing timelines, ensuring compliance, or delivering validated digital content, these teams rely on efficient, high-quality localization to meet global trial demands.

This solution was built to align translation, platform deployment, and regulatory expectations across the clinical development lifecycle.

Who benefits from this workflow:

Accelerate study start-up and reduce localization-related delays on the critical path to trial activation.

Deliver UI-ready translations with integrated linguistic validation and app-based quality checks, reducing late-stage issues.

Gain confidence that translated content aligns with regional submission requirements, including FDA, EMA, and PMDA conventions.

Simplify oversight by consolidating validation, review, and QA processes into one streamlined workflow.

Improve global sponsor satisfaction by deploying culturally appropriate, technically sound translations in all supported languages.

By supporting all stakeholders with a unified model, Sesen enhances efficiency, quality, and collaboration across clinical content teams operating in global study environments.Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.

The Sesen Advantage

The Sesen Advantage

Sesen combines deep industry knowledge with advanced technology to deliver high-quality, compliant localization solutions tailored to life sciences. Our integrated workflow is supported by robust infrastructure, expert linguists, and a commitment to accuracy at every stage of the clinical content lifecycle.

Key strengths that set Sesen apart:

Global language coverage with native, subject-matter linguists specializing in clinical, regulatory, and technical content.

Expertise in PRO instruments, eCOA modules, IFUs, and submission-ready materials aligned with FDA, EMA, and PMDA standards.

Quality management and translation processes independently audited and certified for consistency and reliability.

Proprietary AI technology supports quality review, terminology alignment, and performance benchmarking across languages.

All localization workflows operate in a cloud environment with enterprise-grade data security and compliance.

Together, these capabilities allow Sesen to support complex, multi-language clinical studies with greater speed, accuracy, and transparency.

Related Clinical Localization Solutions

Sesen’s integrated workflow is part of a broader suite of clinical localization services designed to support every stage of global study execution. Explore related solutions that complement and extend the value of our unified approach.

  • End-to-end linguistic validation for PRO, ObsRO, and ClinRO instruments following ISPOR, EMA, and FDA guidelines. Includes forward and back translation, cognitive debriefing, and harmonization across languages.
  • Multilingual localization of electronic and paper-based clinical outcome assessments with in-context UI review to ensure usability, compliance, and cultural relevance.
  • Accurate translation of pharmaceutical and medical device labeling, cartons, and leaflets aligned with regional regulatory language requirements.
  • Specialized translation and formatting of IFUs for medical devices, diagnostics, and combination products to support MDR, IVDR, and global market submissions.
  • Translation of clinical trial documentation that supports Good Clinical Practice (GCP) compliance, including protocols, ICFs, investigator brochures, and site materials.

These services are designed to work independently or as part of an integrated localization strategy that supports accuracy, efficiency, and global regulatory readiness.

Frequently Asked Questions

Yes. While optimized for digital delivery, the Sesen workflow also applies to paper-based PRO instruments, particularly when digital migration is planned. We apply the same rigorous linguistic validation process, including cognitive debriefing and harmonization, to ensure consistency, clarity, and regulatory alignment across both print and electronic formats.

Yes. We offer flexible integration options to accommodate your existing infrastructure. Whether through direct access to your platform or by working with annotated screenshots, our team performs in-context quality assurance to ensure translated content displays accurately and functions properly within your environment.

Yes. Our workflow includes localization aligned with regulatory terminology and phrasing conventions across major global markets, including the European Union, Asia Pacific, and Latin America. Translations are cross-checked against regional guidelines to support compliant, submission-ready content.

Streamline eCOA Translation, Validation, and QA with Sesen's Integrated Clinical Localization Workflows

Sesen’s integrated approach to linguistic validation, in-context eCOA QA, and regulatory review helps life sciences teams reduce complexity, accelerate timelines, and ensure submission-ready quality across all languages. Whether you are launching a global trial or optimizing your current process, our experts are ready to help.

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