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info@oxonepi.com

Medical Writing

Medical Writing

OXON professionals have a strong scientific background in a wide variety of therapeutic areas, so you can outsource the medical writing of your clinical studies with confidence

Our experienced team of medical writers play a critical role in the dissemination of findings of clinical studies, from regulatory documentation to publication of manuscripts, delivering cost-effective documents that meet the highest quality and consistency standards

ACCURACY AND PROFESSIONALISM 

Medical writing at OXON is a service meant to ensure that the  writing of protocols, reports, publications, and other medical documents are in accordance with regulations. Our CRO offers medical writing as part of a full-service program or as a stand-alone service.

Our medical writing team includes clinicians and experienced writers (PhD epidemiologists) with expertise across multiple therapeutic areas, drug development and marketing, who work closely with all departments (Regulatory and clinical operations, Data management and Biostatistics) that contribute to the clinical study.

Each project is assigned to one lead medical writer, who manages the whole medical writing process from the drafting of a communication plan, quality assurance with clinical input and the delivery of outputs according to agreed timelines, generating reliable results for our clients.

HIGH-QUALITY MEDICAL WRITING SERVICES: 

As a global CRO, we offer a range of flexible medical writing services to support your various clinical study documentation needs. From preparation of individual documents (e.g., submission-ready regulatory reports) to extensive medical-writing programs (e.g., from protocol to clinical study report to journal publication).

Among the most common medical writing services, we deliver the following:

Regulatory writing
• Regulatory documentation writing and submission
• Submission of substantial and non- substantial amendments
• Submission of study status reports / Final results reports to Regulatory Bodies

Clinical research studies

• Protocol designs for Phase IV clinical studies
• Protocol designs for Post-Marketing Surveillance (PMS) Studies.
• Case Report Form (CRF) Design
• Study specific questionnaire design
• Patient Questionnaires
• Patient Informed Consent Forms
• Systematic Reviews
• Clinical study newsletters and reports
• Risk Management Plans (RMPs)

Medical writing

• Medical and scientific literature reviews
• Literature Search
• Expert reports and executive summaries
• Interim/Final study report preparation
• Clinical study reports

Scientific publication
• Conference abstracts
• Posters
• Manuscript publications
• Manuscript publications

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