MedTech Medical Writing Services
Medical device manufacturers have a crucial responsibility of meeting all regulatory requirements throughout the medical device product lifecycle. To navigate this complex landscape, sponsors need to have a highly competent hybrid team of Regulatory Affairs SMEs and MedTech Medical Writers.
Medical writing plays a crucial role in the development and approval of medical devices, as well as in ensuring that medical devices are used safely and effectively. It involves creation and preparation of written documents related to the design, development, testing, approval, and use of medical devices. These documents include, but are not limited to, protocols and reports for clinical studies, user manuals, labeling, regulatory submissions (such as pre-market approval or 510(k) submissions to the US FDA), risk management and post-market surveillance reports, and marketing materials.
With over 15+ years experience, our medical writing team has helped several pharma and medical device companies by delivering clinical, non-clinical, regulatory, and post-marketing related medical writing services with the following principles:
Our Medical Writing Services
- Clinical Study Concept & Protocol Synopsis
- Clinical Investigation Plan (CIP)
- Clinical Study Protocol Development
- Study Essential Documents Preparation
- Informed Consent Form
- Case Report Form & Patient Diaries
- Patient Information Sheet
- Survey Questionnaires
- Investigator Brochure
- Study Reference Manuals
- Clinical Study Reports (CSRs)
- CSR Synopsis for public disclosure
- Clinical and Non-clinical sections of the CTD
- Clinical Overview Summaries for EU and US
- Patient Safety Narratives
- Scientific Literature Review Reports
- Clinical Investigation Plan
- CER Writing (Clinical Evaluation Report)
- PER Writing (Performance Evaluation Report)
- PMCF Plan (Post Marketing Clinical Follow up)
- PMCF Study Summary Report
- Manuscript Writing and Publications Support
- Biocompatibility Reports Writing
- Toxicology Reports Writing
- CMC / Analyte Report Writing
- User Manuals and Instructions for Use
- Device Label Documentation
Safety Report Writing
- Periodic Safety Update Reports (PSURs)
- Periodic Benefit-risk Evaluation Reports (PBRERs)
- US FDA Periodic Safety Line Listings
- Risk Management Plans (RMPs)
- Development Safety Update Reports (DSURs)
- Local Safety Summaries (LSSs)
- Safety Signal & Risk Analysis Reports
Medical Affairs & Commercial
- Abstracts, Manuscripts & Posters
- Marketing & Brand Content Development
- Medical Information Content Authoring
- Standard Response Documents
- Prescribing Information & Package Inserts
- Therapeutic Content Presentations
- Conference Poster Presentations
- Journal and Conference Submissions
- Medical marketing Reviews and Reports
Your Questions & Our Answers
There are two types of service models that your company can choose from:
Medical Writing FSP Model: Our team will take the responsibility of managing all medical writing activities for a complete clinical program or for an individual study with a cost-effective pricing structure.
Dedicated Resoucing Model: We can have specialized resources allocated for your organization to hand-hold all types of medical writing needs for a fixed duration.
We use the best of technology platforms that helps us to deliver our medical writing services through continous real-time collaboration with sponsors. Following are some of the systems we use:
Compier Medical Writing Platform: This is our proprietary 100% digital content management platform that facilitates rapid content authoring, completing real-time collaborative review and allows continous content lifecycle management. specifically for rapidly processing soft such as Microsoft Word to create documents.
Reference management software: Our Medical writers use reference management software such as EndNote, Mendeley, or Zotero to manage and organize their references.
Content management systems: If sponsors want us to use content management systems (CMS) like Veeva Vault, Documentum or Sharepoint, our team is familar with how to store and manage documents, track versions, and facilitate collaboration between different team members.
Typesetting software: Medical writers use typesetting software such as LaTeX or InDesign to create well-formatted documents, such as scientific publications and regulatory documents.
Medical Terminology software: Medical writers use medical terminology software such as SNOMED, ICD-10, or MedDRA to ensure accurate and consistent use of medical terms.
With the use of advanced technology and quality-driven processes, our medical writing team members collaborate with Biostatistics, Medical Affairs, Drug Safety and Clinical Data Management teams to deliver accurate and purposeful publications and other medical content with a quick turnaround with 100% compliance to global regulatory requirements. Every medical writing project is meticulously managed and delivered with stringent scientific, statistical, editorial and quality control review.