Are you looking for a medical writer? Our expert team of knowledgeable writers will be happy to develop the right document for your needs, from the early phases to post-approval.
Don’t hesitate to contact us for more information about our medical writing services.
What is medical writing?
All new medical products go through the increasingly complex process of clinical trials and regulatory procedures leading to market approval.
This leads to the demand for well-written, standard-compliant documents that medical professionals can read and understand easily and quickly.
Our expert team of medical writers has the skills required to produce well-structured documents that present information clearly and concisely.
This service includes regulatory/clinical medical writing of documentation required in the regulatory approval process of your drugs, devices, or biological products.
But also educational medical writing to deliver documents for both general and specific audiences, such as healthcare professionals.
For example: literature studies, clinical study protocols, clinical evaluation plans (CEP) and reports (CER), clinical study reports (CSR), patient-informed consent forms (ICF), investigator brochures (IB), Investigational Medicinal Product Dossiers (IMPD), Performance Evaluation Plans (PEP) and reports (PER), etc.
Why QbD Clinical?
At QbD Clinical, we have a team of medical writers at hand, appropriately trained and extensively experienced in all areas of medical writing.
Outsourcing your writing activities will lower your cost of recruitment, training and retention and will give you the time to focus on your core business.
Our Medical Writing services
Clinical Medical Writing
- Investigator Brochure
- Clinical Study Protocol
- Case Report Form
- Informed Consent Form
- Regulatory Applications and submissions
- Clinical Study Report
Regulatory Medical Writing
- Literature Reviews
- Clinical Development Plan
- Risk Management Plan
- Benefit Risk Assessment Report
- Investigational Medicinal Product Dossier
- Patient Safety Narratives
- Drug Safety Update Report (DSUR)
- Annual product reviews (PSUR)
- Standard Operating Procedures (SOPs)
- Translations of Regulatory Documents
Scientific Communications & Publications
- Meeting & Conference Report
- Educational materials
Given the complex nature of the process from pre-clinical to post-approval of your medical product, QbD Clinical understands that your needs are unique. We will tailor our services to meet those needs.
Don’t hesitate to contact us if you have any need for medical writers. Our team of experts can provide you with more information and a custom-made solution.