Nikhil Koranne

Experience

• 

  Cadila Pharmaceuticals

  Jan 2008 - Jan 2009

  Training

  • Successfully undergone six months industrial project work on “In vitro In vivo correlation (IVIVC) of acyclovir 800 mg tablets IR formulation” • Successfully undergone Two months industrial minor project work on “Bioanalytical Method Development of Acyclovir using LCMS/MS technique”

• 

  Zydus Group

  Jul 2009 - Jul 2012

  Clinical Research Associate

  • Clinical Study Document (i.e. Protocol, Informed Consent Form, CRFs) Review• Conduct Site Qualification Visits • Regulatory/Ethics submissions• Organize and coordinate Investigators’ meeting• Conduct Site Initiation Visits• Perform Site Monitoring Visits• Perform close-out visits• Maintain regular phone contact with the sites• Assess the site organization on regular basis in order to secure the quality and support the site• Day to day communication with central or local laboratories, and other providers/vendors (if any) • Study filing: prepare and send all critical documents and translations as per project requirements • Liaise with central laboratory on project management/protocol issues• Participate in internal team meetings• File/archive Project documents• Maintain regulatory documents/Trial Master Files• Perform in house follow-up of issues with the sites• Reconciliation and Management of clinical trial supplies• Follow up for recruitment and enrolment of patients • Data query generation and resolution Show less

• 

  Lambda Therapeutic Research

  Jul 2012 - Jul 2014

  Quality Assurance Auditor

  o Review of Clinical Trial Study Protocols (Phase II – IV including Patient based PK studies).o Conducting retrospective audits of study related raw data like Informed Consent Forms & Personal Information form, Medical Screening records, Clinical raw data like Case Record Forms.o Conducting In-house audits of Clinical Trial Projects.o Preparation and review of Quality Assurance SOPs and review of system SOPs of Clinical Trial Management for correctness, adequacy and completeness.o Conducting system audit, prepare audit report, review responses and to ensure system compliance.o Conducting vendor audits to assess & ensure compliance.o Planning, conducting and reporting Investigational Site audits to ensure the compliance with regards to ICH GCP, SOPs, Quality Systems, Protocols and applicable regulatory requirements.o Conduct of retrospective audit of Clinical Study Report.o Review of Clinical Data Management activities suh as CRF design, SOPs, Clinical database, Data Mangement plan Show less

• 

  Zydus Group

  Jul 2014 - Aug 2018

  GCP QA Auditor

  o Review of Clinical Study Protocols (Phase I – IV including BA/BE) & Clinical Study Reports for USFDA, DCGI & ANVISA submission studieso Conducting retrospective audits of study related raw data like Informed Consent Forms, Medical Screening records, Case Record Forms, Trial master File etc.o Preparation and review of Quality Assurance SOPs and review of system SOPs of Clinical Trial Management for correctness, adequacy and completeness.o Conducting system audit, prepare audit report, review responses to ensure system compliance.o Conducting vendor audits to assess & ensure compliance.o Planning, conducting and reporting Investigational Site audits to ensure the compliance with regards to ICH GCP, SOPs, Quality Systems, Protocols and applicable regulatory requirements.o CAPA, Change Control & Deviation Mangemento Review of Regulatory submission documents for INDs (For e.g. Investigator’s Brochure, General Investigational Plan, Clinical & Non Clinical Summary, SAEs etc.)o Audit of Global Pharmacovigilence Systems & Procedures o Conducting study based audits at CRO & Clinical site audits at Investigator’s site for the studies outsourced to CRO Show less

• 

  SUN PHARMA

  Aug 2018 - Apr 2020

  Manager GCP Quality Assurance
• 

  Veeda Clinical Research

  Apr 2020 - Jun 2022

  Principal Scientist (Lead Auditor)
• 

  Lambda Therapeutic Research

  Jun 2022 - now

  Sr. Project Manager