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I will prepare ethics committee dossier
Clinical content by PharmD CTA: Trusted, tested!
🎓 PharmD Graduate & Medical writing
Experienced in clinical trials, medical writing, and medico-marketing, delivering clear, compliant, and engaging content for CROs, healthcare brands, and startups...
About this Gig
Ill compile and format your EC/IRB submission dossier with all required documentsprotocol, ICF, IB, and safety reportsready for ethics approval. Compliant with local and international standards, I ensure your submission is complete, professional, and regulator-friendly.
- CV of PI
- MRC of PI
- GCP Certificate of PI
- Investigators Undertaking Protocol
- Protocol Signature Page Protocol
- Protocol
- Investigators Brochure
- Informed Consent Document (English)
- Informed Consent Document (Hindi translation with certificate)
- Informed Consent Document (Back translation to English with certificate)
- Subject Diary for Treatment Period (English)
- Subject Diary for Treatment Period (Hindi translation with certificate)
- Subject Diary for Treatment Period (Back translation to English with certificate)
- Subject Diary for Follow-up Visits (English)
- Subject Diary for Follow-up Visits (Hindi translation with certificate)
- Subject Diary for Follow-up Visits (Back translation to English with certificate)
- DCGI NOC Letter
Language:
English
Delivery style preference
Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.
My Portfolio
FAQ
What documents are included in an EC/IRB dossier?
Required documents include PI CV, MRC, GCP, Investigator’s Undertaking, Protocol, IB, DCGI NOC, Informed Consent (English, Hindi, back translation), and Subject Diaries (Treatment & Follow-up in English, Hindi, and back translation).
Do you format documents to local EC/IRB requirements?
es, tailored to your committee’s guidelines.
Can you prepare submission-ready PDFs?
Yes, all documents are compiled and formatted.
Do you include version control and footers?
Yes, I ensure proper versioning and tracking.
Do you provide a checklist of required documents?
Yes, upon request.
Can you assist with cover letters or application forms?
Yes, I can draft or review them.
Do you support both institutional and independent ECs?
Yes.
Can you help with expedited submissions?
Yes, fast delivery is available.
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W walagh12
Saudi Arabia
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Reviews
1 reviews for this Gig
| (1) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
W walagh12
Saudi Arabia
Very good thank you
Up to $50
Price
1 day
Duration
Helpful?
