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Submissions Project Management

Because she started life in the industry as a medical writer, Sandy has a special interest in helping companies develop concise, efficient clinical protocols, investigator brochures and other key clinical trial application (CTA) submission documents to comply with current regulations, and with relevant guidance such as the International Conference on Harmonisation (ICH) Common Technical Document (CTD) format marketing application. She also specializes in INDs in electronic CTD format for FDA and writing INDs in a way that they can easily be transformed into (or from) CTAs in other world regions. Her long-standing interest in writing and language is applied to ensure non-native English writing of her foreign clients is clear and accurate.