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 | ||
|---|---|---|
Development Safety Update Report (DSUR) |
Conference materials |
|
Briefing Books |
Nonclinical Study Protocols |
Manuscripts |
Clinical Development Plan |
Pharmacovigilance documents |
Editorial support |
Development Safety Update Report (DSUR) |
Journal/conference submission |
|
Periodic Adverse Drug Experience Report (PADER) |
Product website content |
|
Lay Summary |
Periodic Safety Update Report (PSUR) |
Educational material |
Risk Evaluation and Mitigation Strategies (REMS) |
Medical marketing reviews and reports |
|
Informed Consent Form (ICF) |
Risk Management Plan (RMP) |
Literature reviews |
Patient Brochures |
Publication planning |
|
Investigational Medicinal Product Dossier (IMPD) |
Independent Review Charter |
Abstracts |
Patient Materials |
Manuscripts |
|
Paediatric Investigation Plan (PIP) |
Patient Safety Narratives |
Postmarketing Studies |
Pediatric Study Plan (PSP) |
Standard Operating Procedures (SOPs) |
Posters |
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.