It’s been recognized that a misleading or confusing written document has the potential to ruin the opportunity of a well-designed and performed project. Saliegral teams understand the criticality of clear, accurate & interesting written documents and hence play a crucial role in preparation of scientifically rigorous, customized medical and scientific communications, and regulatory documents supporting pharmaceutical products, diagnostics, and devices across the product life cycle.

• Clinical Protocol/Clinical Investigation Plan Development
• CRF designing and development
• Informed Consent Form/Ascent Forms Designing and Development
• Investigator’s Brochure (IB) development
• Development of IMPD
• eCTD Modules 2.5 and 2.7
• Preclinical study reports
• Safety Narratives
• Annual Reports for Regulatory Agencies and Ethics Committee
• Interim and Final Clinical Study Reports (CSR)
• Clinical Evaluation Reports (CER)
• Abbreviated Clinical Study Reports or Synopsis
• Publication Manuscripts and Posters
• Protocol Slide Kits & Investigator Training Material
• Site Source Documents Development- patient diaries, source document template etc.