Aditi Jain

Honours' Dissertation Title - Navigating the Complexities of Human Brucella canis Infections: Scoping Review of Global Clinical evidence on Clinical Presentation, Diagnostics, Treatment, & Epidemiological Pattern

• Designed a preclinical trial proposal for innovative gastroenterology therapy 'ALDP_025,' developing in-vitro/in-vivo models & optimizing trial timelines, resulting in board approval for next-phase research.
• Spearheaded the development of Denosumab promotional literature by conducting a systematic literature review & statistical analysis, reducing project delivery time by 20%.
• Refined Bevacizumab Phase 4 clinical protocols, aligning cross-functional team inputs, & conducted site initiation visits (SIVs) across major institutions to ensure compliance with regulatory standards.
• Engaged in SIVs across multiple cities, demonstrating meticulous attention to overseeing SIV documents & procedures. 

• Streamlined regulatory submissions by drafting product characteristics & patient leaflets compliant with MHRA & EMA,
  improving first-pass approval rates.
• Developed 5+ Standard Operating Procedures & pharmacovigilance agreements, enhancing operational compliance
  by 30%.
• Conducted quality assurance activities, including analytical testing (HPLC, pH, osmolality), reducing batch testing time by 15%.
• Facilitated production process improvements by auditing GMP protocols & providing actionable insights, increasing output
  efficiency by 20%.

• Supported vaccine development by aligning 4 study protocols with NDCTR, MHRA, & FDA guidelines, ensuring seamless regulatory submissions.
• Reviewed case reports & safety documentation, improving pharmacovigilance reporting accuracy by 15%.
• Participated in the design & implementation of investigator brochures & informed consent forms, expediting trial readiness by 10%.