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This service entails the generation of well-structured individual reports to extensive medical writing programs, including:
| a) |
SAE Narratives for Clinical Study Reports |
| b) |
Clinical Study Protocols |
| c) |
Clinical Study Reports (ICH-E3) |
| d) |
IND Annual Reports (21 CFR 312.33) |
| e) |
Clinical Summaries/Product Feasibility Reports for Medical Devices |
| f) |
Manuscripts and Publications |
| g) |
Patient Diary Cards (PDC), Informed Consent Form (ICF), Subject Information Sheet (SIS), Case Report Forms (CRFs) |
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