Medical writing services are focused on preparing clear, concise, and high quality documents, easy to read for regulatory approval, trial participants, investigators, and co-coordinators.
- Investigator’s Brochure
- Informed Consent Document
- Patient Information Leaflets
- Safety Data Reports
- Medical Translation Services
- Regulatory Submissions
- Clinical study protocol & protocol amendments
- Clinical study synopsis
- Case Report Forms (CRF) Design Development
- Database Design & Development
- Data Entry & Data Validation
- Query Management
- Coding of Adverse Event & Concomitant Medication [Med DRA & WHO-DD]
- Reconciliation of Serious Adverse Events
- Protocol Input for Statistical Section
- Sample Size Calculation, Randomization & Blinding
- SAS Coding, Statistical Analysis & Report Generation
- Consent documents (with translations in various Indian languages as required)
- Clinical study reports (as per ICH-E3)
ARL clinical section mainly follows ICH-E3 Guidelines (Structure and Content of Clinical Study Reports) for preparation of clinical reports. Reports are also generated as per the format of regulatory agency of submission country.
Other Standard Guidelines referred are
- ICH/GCP Consolidation Guidelines (ICH-E6)
- Compliance with regulations of 21 CFR Part: 50, 56, 320
- EU Clinical Trial Directives 2001/20/EC and 2005/28/EC
- Annexure 7, 8 & 9 of WHO TRS 937 additional guidance