Miteshkumar Patel Email & Phone Number

Toronto, On, Ca

Ontario, Canada

Toronto, Ontario, Canada

 Perform site qualification visits, site initiation visits, pre-study visits, dosing visits, interim visits, SDV visits, close-out visits, Audit visits etc. as per the monitoring plan and agreement with sponsors.  Travel to various sites at various countries to perform monitoring activities.  Monitoring of bioequivalence studies, SAD-MAD studies, early phase and late phase studies, for international pharmaceutical clients to ensure CRO's and clinical sites' conformity with… Show more  Perform site qualification visits, site initiation visits, pre-study visits, dosing visits, interim visits, SDV visits, close-out visits, Audit visits etc. as per the monitoring plan and agreement with sponsors.  Travel to various sites at various countries to perform monitoring activities.  Monitoring of bioequivalence studies, SAD-MAD studies, early phase and late phase studies, for international pharmaceutical clients to ensure CRO's and clinical sites' conformity with regulations, subject safety, and data integrity. Source Data Review of paper based CRF and/or eCRF like Medrio, Rave, Investigator, Biznet, Viva Vault performing efficient collaboration with investigators, study coordinators, and regulatory specialists. Compliance with ICH-GCP and GLP, SOPs, FDA, EMA, TPD, ANVISA, DCGI and other regulations Ensure that all regulatory documents and approvals are in place prior to subjects' enrolment with sites. Ensure that the investigator and staff are qualified to conduct the study and that the facility and equipment are adequate. Ensure that the Investigational products are handled, stored and dispensed as per the protocol specifications. Ensure that the sites obtained and documented proper informed consent forms before start of any study specific activities. Verify proper completion of the CRF and source documents when applicable. Perform review of accountability records of investigational products and ensures reconciliation of records at the study close out visit. Liaise with the sponsor to ensure open communication, proper dissemination of information and rapid action when required. Prepare monitoring plan, study updates, monitoring visit reports, corrective and preventive actions, Protocols, ICFs, CRFs, CSRs, SOPs, Report templates etc. Show less

Toronto, Ontario, Canada

 Perform site qualification visits, site initiation visits, pre-study visits, dosing visits, interim visits, SDV visits, close-out visits etc. as per the monitoring plan and agreement with sponsors.  Travel to various sites at various countries to perform monitoring activities.  Monitoring of bioequivalence studies, SAD-MAD studies, early phase and late phase studies, for international pharmaceutical clients to ensure CRO's and clinical sites' conformity with regulations, subject… Show more  Perform site qualification visits, site initiation visits, pre-study visits, dosing visits, interim visits, SDV visits, close-out visits etc. as per the monitoring plan and agreement with sponsors.  Travel to various sites at various countries to perform monitoring activities.  Monitoring of bioequivalence studies, SAD-MAD studies, early phase and late phase studies, for international pharmaceutical clients to ensure CRO's and clinical sites' conformity with regulations, subject safety, and data integrity. Source Data Review of paper based CRF and/or eCRF like Medrio, Rave, Investigator, Biznet, Viva Vault performing efficient collaboration with investigators, study coordinators, and regulatory specialists. Compliance with ICH-GCP and GLP, SOPs, FDA, EMA, TPD, ANVISA, DCGI and other regulations Ensure that all regulatory documents and approvals are in place prior to subjects' enrolment with sites. Ensure that the investigator and staff are qualified to conduct the study and that the facility and equipment are adequate. Ensure that the Investigational products are handled, stored and dispensed as per the protocol specifications. Ensure that the sites obtained and documented proper informed consent forms before start of any study specific activities. Verify proper completion of the CRF and source documents when applicable. Perform review of accountability records of investigational products and ensures reconciliation of records at the study close out visit. Liaise with the sponsor to ensure open communication, proper dissemination of information and rapid action when required. Prepare monitoring plan, study updates, monitoring visit reports, corrective and preventive actions, Protocols, ICFs, CRFs, CSRs, SOPs, Report templates etc. Show less

Toronto, Ontario, Canada

 Wrote Phase 1 and Bio-equivalence Study Protocols, Informed Consent Forms, and Clinical Study Reports.  Prepared additional electronic files as required by Regulatory Agencies (e.g., eCTD, CSBE, FDA BE Summary Tables, EMA Module 2.7.1 Tables). Performed Data Entry and Verified accuracy of data entered Assisted in the development of document templates, relevant Standard Operating Procedures (SOPs) and guidelines. Worked closely with clinical personnel and the Principal… Show more  Wrote Phase 1 and Bio-equivalence Study Protocols, Informed Consent Forms, and Clinical Study Reports.  Prepared additional electronic files as required by Regulatory Agencies (e.g., eCTD, CSBE, FDA BE Summary Tables, EMA Module 2.7.1 Tables). Performed Data Entry and Verified accuracy of data entered Assisted in the development of document templates, relevant Standard Operating Procedures (SOPs) and guidelines. Worked closely with clinical personnel and the Principal Investigator to ensure that clinical documents are produced to the standard required by Good Clinical Practice (GCP).  Ensured shipment of final reports to sponsor with all correspondence. Conducted all work in compliance with SOP’s, GCP and to observe all regulatory guidelines. Negotiated timelines with external departments. Show less

Ahmedabad Area, India

 Prepared study protocols, study reports, ICFs, CRFs for Bioequivalence studies and clinical trials. Prepared Clinical & Nonclinical reports for products for European submission. Prepared Product Monographs, Prescribing information and MSDS for various countries. Audited and Monitored Study sites for BA / BE studies and Clinical trials.  Ensured timely conduct of clinical trials and comply with GCP guidelines, SOPs and applicable regulatory. Coordinated all site… Show more  Prepared study protocols, study reports, ICFs, CRFs for Bioequivalence studies and clinical trials. Prepared Clinical & Nonclinical reports for products for European submission. Prepared Product Monographs, Prescribing information and MSDS for various countries. Audited and Monitored Study sites for BA / BE studies and Clinical trials.  Ensured timely conduct of clinical trials and comply with GCP guidelines, SOPs and applicable regulatory. Coordinated all site activities ensuring protocol & regulatory requirement(s) were met. Monitored investigational product accountability, dispensing, dosing, blood sampling and other study related activities. Maintained study files, site essential other study related documentation. Entered data in electronic Case Report Form, including patient diary information. Addressed study sites queries, promptly. Reported Adverse Events and Serious Adverse Events proactively.  Source documents verification and monitored whole study at the various study site/s. Provided regulatory support for launching new drug. Show less

Ahmedabad Area, India

 Conducted various Bioavailability / Bioequivalence studies for various regulatory authorities. Ensured timely conduct of studies and comply with GCP guidelines, SOPs and applicable regulatory. Responsible for coordination of all activities necessary for the conduct of the trial and proper communication with the sponsors, ethics committee, etc. Prepared protocols, ICFs, CRFs and other protocol related documents as per international norms. Clinical reports preparation for… Show more  Conducted various Bioavailability / Bioequivalence studies for various regulatory authorities. Ensured timely conduct of studies and comply with GCP guidelines, SOPs and applicable regulatory. Responsible for coordination of all activities necessary for the conduct of the trial and proper communication with the sponsors, ethics committee, etc. Prepared protocols, ICFs, CRFs and other protocol related documents as per international norms. Clinical reports preparation for submission to various regulatory authorities. Protocol, SOPs and GCP training to the study personnel for better quality of trial. Handling of research drugs. Revision and maintenance of systems and SOPs. Show less

Master Of Pharmacy, Pharmacology, First

Postgraduate Diploma, Entrepreneurship/Entrepreneurial Studies, First

Bachelor'S Degree, Pharmacy, First