Translation Services for Contract Research Organizations (CROs)

Specialised translation services for pharmaceutical, medical documents, regulatory, biotech, and medical device sectors.

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Accurate, Regulatory-Compliant Translation for Global Clinical Research

From clinical trial protocols and informed consent translation to regulatory documentation and post marketing safety reports, Anan Translations deliver high-quality healthcare translations for complex research environments. Our expertise includes pharmacovigilance translation, trial master file translation, and multilingual clinical trial translation, supporting submissions to regulatory bodies and regulatory agencies in the United States, Europe, India, and other global markets.

We combine subject matter expertise with a structured translation process and strong regulatory knowledge. This ensures every document meets Good Clinical Practice (GCP) standards through dedicated ICH GCP translation, FDA-compliant translation, and precise EMA document translation workflows.

What Are Contract Research Organizations (CROs)?

Contract Research Organizations (CROs) support pharmaceutical, biotech, and medical device companies throughout the drug development lifecycle. CROs manage:

Clinical trial planning and execution
Regulatory affairs coordination
Regulatory documentation preparation
Pharmacovigilance reporting
Site management and patient recruitment

As clinical trials expand into new countries, accurate translation into the target language is critical. It protects patient safety, supports ethical approval, and ensures regulatory clearance.

CROs rely on specialized pharmaceutical translation and medical document translation to maintain compliance and clarity across global trial sites.

Industries We Support

We provide specialized translation services for CROs supporting global clinical research across multiple therapeutic and scientific areas.

Pharmaceutical Drug Development

Biotechnology Research

Medical Device Trials

Vaccine Research

Oncology Studies

Rare Disease Programs

Biosimilar Research

Why CROs Need Specialized Translation Services

Clinical research documents are highly technical and reviewed by multiple regulatory bodies. Even minor translation errors can lead to:

Delays during the regulatory review process
Rejection by regulatory agencies
Ethics committee queries
Misinterpretation by trial participants

Unlike general translation agencies that serve many industries, Anan Translations concentrates entirely on regulatory translation, pharmaceutical translation, biotech translation services, and medical device translation for clinical research.

We ensure compliance with:

Good Clinical Practice (GCP) guidelines through structured ICH GCP translation
ICH standards
FDA requirements in the United States via a validated FDA compliant translation
EMA requirements through accurate EMA document translation
Other international regulatory bodies

Our CRO Translation Services

We support Contract Research Organizations at every stage of clinical research with specialized solutions.

Our multilingual clinical trial translation covers:

Informed Consent Forms (ICF) – professional informed consent translation
Clinical trial protocols
Case Report Forms (CRF)
Investigator Brochures
Trial Master Files – accurate trial master file translation
Patient questionnaires and diaries
Recruitment materials

All documents are translated into the participant’s native language to ensure comprehension and regulatory compliance.

Our regulatory translation services include:

IND and NDA applications
CTD and eCTD dossiers
Ethics Committee and IRB submissions
Regulatory correspondence
Labelling and package inserts

We deliver pharmaceutical translation and medical device translation that align with FDA compliant translation standards in the United States and EMA document translation requirements in Europe.

Our pharmacovigilance translation services support ongoing safety monitoring and compliance, including:

Adverse event reports
Safety narratives
Periodic Safety Update Reports (PSUR)
Risk management documentation
Post marketing surveillance reports

Accurate regulatory translation in post marketing activities ensures continued compliance with international regulatory bodies.

We provide:

Pharmaceutical translation for drug development programs
Biotech translation services for biologics and biosimilars
Medical device translation for technical files, IFUs, and clinical evaluation reports

Each service is delivered with subject matter expertise and strict regulatory awareness.

Structured Translation Process for CROs

Our Structured Translation Process for CROs

A clearly defined translation process built for regulated environments and high-risk regulatory documentation.

Project Assessment & Terminology Review

We analyze regulatory documentation and prepare approved terminology for pharmaceutical translation, medical document translation, and regulatory translation assignments to ensure consistency and compliance.

Translation by Subject Matter Experts

Documents are translated by linguists with clinical research and regulatory affairs expertise, ensuring precise medical terminology and accuracy in the target language.

Independent Review Process

A second qualified reviewer validates accuracy, clarity, and consistency — essential for FDA-compliant translation and EMA document submission.

Back Translation (When Required)

Frequently used for informed consent translation to confirm conceptual accuracy, regulatory equivalence, and suitability for ethical approval.

Final Quality Assurance

Comprehensive compliance, formatting, and linguistic checks are performed before final delivery to ensure readiness for submission to global regulatory agencies.

Multilingual Support for Global CRO Operations

Anan Translations offers multilingual clinical trial translation across:

Major Indian languages
European languages
Asian languages
Middle Eastern languages

Every project is handled by native language medical linguists experienced in pharmaceutical translation, regulatory translation, and medical document translation, ensuring clarity for patients, investigators, and regulatory authorities.

Why Choose Anan Translations

Why Choose Anan Translations Over Other Translation Agencies?

Clinical research demands more than general translation services. CROs require subject matter expertise, regulatory compliance, and high quality translation for critical regulatory documentation.

What General Translation Agencies Offer

Generic linguists serving multiple industries
Limited regulatory affairs experience
Basic linguistic review process
No clinical trial specialization
Standard turnaround models

What Anan Translations Delivers

Specialized Expertise

Deep experience in pharmaceutical translation, biotech translation services, and medical device translation for global clinical trials.

Regulatory Compliance

Proven delivery of FDA compliant translation, EMA document translation, and ICH GCP translation aligned with regulatory agencies worldwide.

High Quality Translation

Multiple review layers ensure accuracy, consistency, and readiness for submission to regulatory bodies.

Cost-Effective Solutions

Scalable, cost effective translation services tailored for CROs, pharmaceutical companies, and biotechnology firms.

Data Confidentiality

Secure handling of sensitive clinical and regulatory documentation throughout the translation process.

Reliable Turnaround

On-time delivery aligned with regulatory submissions, ethics approvals, and trial timelines.

Trusted by CROs, pharmaceutical companies, and biotechnology firms conducting global clinical trials in the United States and internationally.

FAQs

What makes CRO translation different from general translation?

CRO translation involves pharmaceutical translation, regulatory translation, and multilingual clinical trial translation aligned with ICH GCP standards.

Do you provide informed consent translation?

Do you support FDA and EMA submissions?

Is pharmacovigilance translation required post marketing?

Do you handle trial master file translation?