We provide medical writing services across all phases of drug development and offer expert guidance and support for the preparation of the following documents:
Clinical Study Protocols
Informed Consent Forms
Clinical Study Reports for Phase I to IV trials per ICH guidelines
PBRERs
DSURs/IND Annual Reports
Risk Management Plans
120-day Safety Update Reports
100% QC of all documents against source documentation and style guides
QC to verify consistency within a document or between documents in a filing application
Multinational Pharmaceutical Company
“Thanks for all your work, flexibility, and diligence on this protocol amendment. You did a great job!”
Multinational Pharmaceutical Company
“Well done! And thanks again for your superhuman efforts in getting this CSP over the line – it’s certainly been a challenge.”
Top CRO
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“Thank you very much for making this report possible! I appreciate your thorough work and critical review.”