Clinical Review

Ensure your medical documents are approval ready and clinically relevant, meeting the industry standards to aid a smooth localization workflow.

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What is Clinical Review?

At Somya Translators Pvt. Ltd, our Clinical Review process is an essential element in guaranteeing the quality and precision of clinical and medical document translations, as well as medical device localization. Our Clinical Review emphasizes authenticating the translation’s clinical relevance and adherence to industry standards and regulations, making it an indispensable step in the workflow of localization.

Purpose of Clinical Review

The Clinical Review aims to:

Ensure Clinical Relevance: Verify that the translation is accurate and clinically relevant, adhering to the specific requirements of medical and clinical contexts.
Compliance with Standards: Check that the translation follows industry-standard terminology and style, ensuring that it aligns with regulatory guidelines.

Our Clinical Review Process

Translation Assessment: : Our subject matter experts, with backgrounds in medicine or clinical fields, perform a thorough review of the translated content. They focus on ensuring that the clinical trial translations retain the original intended meaning and adheres with clinical and official standards.
Quality Control : The review process involves checking the accuracy of industry-specific terminology and ensuring the translation is free from grammatical or spelling errors. Issues are identified and resolved before final submission.

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Document Types for Clinical Review

Our Clinical Review services encompass a wide range of essential clinical documents, that include:

Protocol : Comprehensive guidelines for treatment planning in clinical trials.
Protocol Synopsis : Condensed versions of clinical protocols.
Informed Consent Form and Patient Information Sheets :Documents explaining participants' rights, study details, risks, and benefits.
Ethics Committee’s Correspondence :Communication regarding drug or treatment approvals or rejections.
Patient Diary : Handwritten records by patients reporting their outcomes and experiences.
Adverse Event Report : Reports on negative effects or reactions to drugs or treatments.
Investigator's Brochure : Comprehensive documents summarizing information about investigational products during drug trials, including dosage, administration methods, safety procedures, and data for managing clinical trials.

Why Opt for Our Clinical Review Service?

Choose Somya Translators Pvt. Ltd., for a Clinical Review process that make your medical and clinical translations are precise, compliant, and prepared for critical applications.

Specialist Expertise

Our Clinical Review is undertaken by efficient Subject Matter Experts with medical and clinical backgrounds, who make sure that the translations are both clinically precise and pertinent.

Regulatory Compliance

We prioritize compliance and conduct with the industry-standard terminology and official guidelines, making sure that your content fully meets all the required standards.

Types of Documents we Translate for Clinical Review Translation

Case-control Study
Clinical Evaluation Report
Clinical Practice Guidelines

Clinical Research Protocol Design
Clinical Trial
Digital Clinical Trials

Phase III Trial
Good Clinical Practice
Oncology Clinical Research

Medical review
Systematic Review

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