Medical Writing
OUR TEAM’S EXPERTISE
- Diverse Therapeutic Expertise:
- Our medical writing services cover a broad spectrum of therapeutic areas.
- Performed by experienced medical writers holding PhDs in life sciences, with over a decade of experience.
- Integration with Clinical Development Teams:
- Our medical writing service seamlessly integrates with multidisciplinary clinical development teams.
- Experienced Scientific Writers:
- Our team of scientifically oriented writers possesses significant experience in crafting clinical documents.
- Regulatory Document Excellence:
- We excel in crafting regulatory documents that support submissions to regulatory agencies for drugs, devices, and diagnostics.
- Regulatory Environment Proficiency:
- We understand the intricacies of writing within highly regulated environments and are well-versed in the requirements of regulatory agencies.
HOW WE HELP YOU
Medical Writing for Clinical Trials & Regulatory Submissions
Clinical Trial and Program Documentation:
- Protocol-related Documentation:
- Protocol synopsis, protocols, and amendments
- Informed consent forms
- Clinical study reports (CSRs)
- Safety narratives
- Clinical development plans
- Investigator brochure and patient information leaflets
- Annual reports
- Periodic safety update reports (PSURs)
- Development safety update reports (DSURs)
- Periodic benefit-risk evaluation reports (PBRERs)
Regulatory Submission Documents:
- Marketing Applications in eCTD Format:
- IND (Investigational New Drug)
- CTA (Clinical Trial Application)
- NDA/sNDA (New Drug Application/supplemental NDA)
- MAA (Marketing Authorization Application)
- NDS (New Drug Submission)
- jNDA (Japanese New Drug Application)
- Clinical & Non-Clinical Summaries (Module 2)
- Integrated Summaries of Efficacy and Safety (Module 5)
- Responses to Agency Reviewers
- Regulatory Briefing Documents for Agency Meetings, including:
- Pre-IND
- End of Phase 1
- End of Phase 2/3
- Pre-NDA
- Advisory Committee Meetings
- Orphan Drug Designation Applications
- Risk Management Plans
eCTD services
- Create and edit eCTD documents according to ICH and national regulatory authority guidelines.
- Manage documents and eCTD sequence lifecycles on a dedicated document management system.
- Create and publish eCTD sequences on a dedicated eCTD compilation system.
- Validate eCTD sequences using specialized validation tools.
- Submit eCTD sequences to regulatory agencies.
Phone Support
- Hours: Mon-Fri, 9:00 AM – 8:00 PM ET
- Contact: +1 (650) 460-7431
- Availability: 365 days per year
- Contact:info@amstatisticalconsulting.com
- We will respond within 1 hour during business hours.
- Please briefly overview your research project, your deadline, and the specific support you require.
24/7 Chat Support
- Please click our chat icon in the right corner of our website.
- Mobile users: To access our chat icon, please click ‘Exit mobile version’ at the end of our website.
Contact Form
- Please fill out our contact form in the left corner of our website.
- We will respond within 1 hour during business hours.
- Mobile users: Please click ‘Exit mobile version’ at the end of our website to access our contact form.
Office Visit
- Address: 530 Lytton Avenue, 2nd Floor, Palo Alto, CA 94301
- Please schedule an appointment to visit us.
Your confidentiality is our priority. Non-disclosure agreements are available upon request.