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Medical Writing

For safety and all benefits related to the use of pharmaceuticals, medicines, vaccines and medical devices, the world of medical therapy is strictly controlled and regulated. It must undergo rigorous clinical trials before a new therapy can be introduced to the market, as part of the controlled clinical development process. The development plan, procedure description, unexpected circumstances or contingencies, results, observations and conclusions must all be recorded and documented. In the pharmaceutical industry, these documents are often referred to as "regulatory documents".

The clinical development of new drugs, vaccines, medical devices, and other therapies is a difficult task. When deciding whether to approve a new drug, reviewers and regulators usually see the clinical documents accompanying the application. However, lack of resources, inadequate training or insufficient medical writing experience may hinder the challenge of creating good documentation and communications. This is why you should cooperate with a specialised medical writing provider. All our documentation complies with these standards, including International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) standards, ae well as European, US, and other local regulatory requirements.

Our Strength
  • A Dedicated Writing Team
  • Sufficient Resources
  • Documents Tuned to Different Audience
  • Therapeutic and Development Area Experience
  • Standardised and Compliant Document Formats
  • Flexible Outsourcing Pattern
  • Project Delivery on Time and on Budget
Clinical, Regulatory, Pharmacovigilance and Scientific Communications Writing

Clinical Documentation

Development Safety Update Report (DSUR)

Conference materials

Briefing Books

Nonclinical Study Protocols

Manuscripts

Clinical Development Plan

Pharmacovigilance documents

Editorial support

Clinical Study Protocol (CSP)

Development Safety Update Report (DSUR)

Journal/conference submission

Clinical Study Report (CSR)

Periodic Adverse Drug Experience Report (PADER)

Product website content

Lay Summary

Periodic Safety Update Report (PSUR)

Educational material

Common Technical Document (CTD)

Risk Evaluation and Mitigation Strategies (REMS)

Medical marketing reviews and reports

Informed Consent Form (ICF)

Risk Management Plan (RMP)

Literature reviews

Investigator's Brochure (IB)

Patient Brochures

Publication planning

Investigational Medicinal Product Dossier (IMPD)

Independent Review Charter

Abstracts

Investigational New Drug (IND)

Patient Materials

Manuscripts

Paediatric Investigation Plan (PIP)

Patient Safety Narratives

Postmarketing Studies

Pediatric Study Plan (PSP)

Standard Operating Procedures (SOPs)

Posters

Clinical Evaluation Report (CER)

Standalone Quality Checks

Slide Sets

Our medical writers flexibly meet your needs, using our expertise to transform your complex and diverse data into accurate and evidence-based clinical profiles of medications relevant to treatment and patient safety. All documents produced by MedTrans undergo thorough scientific, statistical, editorial and quality control review. We are dedicated to delivering accurate, timely, and cost-effective clinical and regulatory documents to the highest quality and scientific standards. Our medical writing services include clinical and regulatory writing, as well as scientific communications, education material and medical writing consultancy.

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