Bansi Solanki

• Clinical study initiation or start-up review.
• Coordination with Project Managers, Clinical Trial Assistants and Clinical Research Associates for site identification for a proposal.
• Understanding of Good Clinical Practice (GCP) and New Drug and Clinical Trail rules (NDCT).
• Customization of Feasibility Questionnaire both brief as well as detailed based on the protocol.
• Circulating the Feasibility Questionnaire (brief as well as detailed) to the site and other relevant persons for their review and approval.
• Collect and reviews all regulatory documents (Ethics Committee) and Technical documents (CDA, FQ, IU, PSP, CV, MRC) from sites, tracks all information for reference, and maintain documentation as required.
• Preparation of IMP release document.
• Maintaining up to date study documents in eTMF.
• Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, master patients visit tracking, IMP related tracker and PK, PD, IM sample tracking.
• Maintaining clinical systems that track site compliance and performance within project timelines.
• Assist the PM in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures at Lambda

· Routine Analysis of Initial as well as stability samples of solid oral dosage form by assay, dissolution, related substance, water content etc.

· Dissolution development, assay development

· Multimedia dissolution study of drug product.

· Stability data compilation.

· Verification of analytical method parameter.

· Analytical method development report.

· Calibration of analytical instruments like Dissolution and HPLC.

· I possess command on analytical subjects along with the regulations and guidelines of ICH and GLP.

· Literature search for development purpose

· Familiar with Empower-3 and Custom filed calculation.