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Medical Writing & Submission

Clinical Trials >> Medical Writing & Language Translation >> Clinical Research Translation / Validation

The Medical Writing Services group at PAREXEL is uniquely qualified to help you compile, organize, write, edit, and produce a wide range of medical and scientific documentation required to support your product development efforts.

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Medical Coding

Clinical Trials >> Medical Writing & Language Translation >> Clinical Research Translation / Validation

DZS medical coding services combine the power of experienced medical terminology coders with our proprietary coding software tool, ClinPlus®.

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Medical Writing

Clinical Trials >> Medical Writing & Language Translation >> Clinical Research Translation / Validation

Clinical study report according to FDA guidance for industry and related submissions using eCTD specification.

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Certified Translation & Language Services

Clinical Trials >> Medical Writing & Language Translation >> Clinical Research Translation / Validation

With more than 300 drug products and vaccines currently in clinical trials, TransPerfect's expertise in medical and life science translation and language services provides the quality, efficiency, and reliability necessary to compete in this fast-paced industry.

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eCRF & Paper Design

Clinical Trials >> Medical Writing & Language Translation >> Clinical Research Translation / Validation

The Clinical Data Management unit efficiently manages all aspects of data handling in accordance with the protocol, the data management plan, efficient data capture, accurate data and timely completion of the clinical database.

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Medical Writing

Clinical Trials >> Medical Writing & Language Translation >> Clinical Research Translation / Validation

Chiltern’s industry-leading team of data management professionals and statisticians is one of the largest in the industry. With real-world experience in adaptive trial designs and the latest data analytics platforms and technologies, we make certain you can not only access, but also examine

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Protocol Preparation

Clinical Trials >> Medical Writing & Language Translation >> Clinical Research Translation / Validation

Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Clinical Evaluation Report (CER)

Clinical Trials >> Medical Writing & Language Translation >> Clinical Research Translation / Validation

Factory has an expert team of medical writers that has this knowledge and experience and that can help you compiling these reports making sure you do it right the first time so you don’t loose time and resources.

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Medical Writing & Healthcare Communications

Clinical Trials >> Medical Writing & Language Translation >> Clinical Research Translation / Validation

Our writers prepare documents that are clear, concise, compelling, and scientifically accurate, while also ensuring they are fully compliant with regulations, industry best practices, and your corporate guidance.

Language Scientific has been providing medical and clinical research translation services to Clinical Research Organizations (CRO) for over 15 years. Our customers in the clinical research industry include Quintiles, PharmaNet, Bioclinica, and PRA International. We translate a wide variety of medical documents from Protocols and Pharmacological Studies to Informed ConsentForms, Patient Questionnaires and Interactive Voice Response (IVRS) prompts. Knowing full well how important translation quality and content accuracy are to successfully pass drug registration requirements, Language translation companies follows multiple strict ISO quality processes to guarantee that your application will run smoothly without any delays. Leading clinical research companies as well as drug manufacturers conducting clinical trials translations have come to depend Medical Translation of clinical trial translation experience. With ISO Certifications, J2450 compliance, ISO backed Quality Assurance workflow designed specifically for client companies ensures consistency across all languages and timely delivery to meet all your application schedules. Various steps where medical coding and clinical translation companies can help are product development and registration process, including: Clinical research, Phases 0 - IV of clinical trials, Surveys, Drug testing, Regulatory approval dossiers, Registration submission and review, Production and marketing. Pharmaceutical Translators are handpicked doctors and clinicians who understand the content based on first hand interaction with patients locally. Doctor translators are provided with training on the methodology of the clinical trial process and the end client’s requirements. Owing to a strict internal quality control protocol, they are able to provide a Certificate of Translation Accuracy with each project. The typical documents which are translated for Clinical Industry clients include: Adverse Event Source Documents Case Report Forms (CRFs), Data Sheets, Development Safety Update Reports (DSURs), Dossiers, Drug Registration Documentation, Endpoint Adjudication Documents, Informed Consent Forms, Insert Leaflets, Instructions for Use (IFUs), Marketing Collateral, Master Batch Records, Package Inserts and Labels, Patient Diaries, Patient Recruitment Materials, Patient Reported Outcome Measures (PROMs), Patient Source Documents, Admission and Discharge, Labs, Pharmacological Studies, Product Labels, QoL Scales, Regulatory Documents, Scientific Papers, Study Protocols, Suspected Unexpected Serious Adverse Reactions (SUSARs), Toxicology Reports. Linguistic or Multilinual reviews are conducted by our qualified linguists who specialize in Life Sciences, and who ensure the language, stylistic and terminological correctness and consistency of the translated material. Linguistic Validation services for Patient-Reported Outcomes in accordance with the guidelines developed and provided by the FDA and ISPOR, followed by a complete report.

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