DR YAGNIK VYAS

• To laise with the Head-technical operations, Head-Bioanalytical
• Reporting, detection, Assessment and monitoring of Adverse Drug Reactions Management of adverse event and serious adverse event and to ensure adequate-medical care for the subject during adverse event and whenever required
• To organize conduct and management of the clinical phase of BA/BE studies and clinical trials in-compliance with ICH-GCP, GLP, SOPs and applicable local regulatory guidelines and with in timelines.
• To write and revise SOPs as per the need and ensure implementation.
• To impart GCP and other technical training to the personnel On SOPs and applicable-procedures identified
• To supervise BE project activities and clinical trials and co ordinate with other departments till completions per committed timelines and oversee the project documentation, completion andarchiving of reports, raw data and SOPs.
• To devise strategies for volunteer recruitment and to organize screening of prospective-study subjects.
• To manage the recruitment of manpower during the conduct of BE studies/Clinical trials for various responsibilities at the facility.
• To liaise with an accredited pathology and Xray laboratory for proficiency testing of biochemistry parameters and procure laboratory supplies.
• To account or study drug samples according to the GCP guidelines.
• Additionally overseeing the activities of RAs, Nurse, Phlebotomist and contractual staff(Physician/dietician/Nurse/Phlebotomist).
• To design, conduct, perform, record, analyze and report or BA/BE studies and clinical trials.
• Responsible to conduct and complete the study in compliance with the protocol agreed with the sponsor (and he should sign the protocols) with GCP and other applicable regulatory requirement, guidelines.
• To ensure the availability of adequate number of qualified staff and facilities for proper-and safe conduct of BA/BE studies and clinical trials and also responsible for protocol-training and duty delegation of staff member.
• To ascertain rights, safety and wellbeing of the subject.
• To communicate with IEC for approval of clinical project protocol and "Informed consent document and other study related document and any amendments thereof.
• Responsible to monitor and audit the study progress.
• To ensure appropriate use of Investigational product and its required documentation.
• To ensure GCP and other regulatory requirements compliance
• To ensure conduction and completion of the project
• Responsible for all study related clinical decisions and also providing reason if subject withdrawn from the clinical study
• To identify protocol deviation (if any) and to ensure no deviation.
• To provide any update for subject recruitment procedures.

• Place of Birth: Bhavnagar, Gujarat
• Father's Name: VIJAYBHAI VYAS
• Date of Birth: 04/07/1992

1) Phase I study - Propofol Study Clinical Drug Trail at External Hospital ICU with Close Monitoring for Adverse Drug Reactions(SAAL Hospital, Ahmedabad)

2) Glucose Clamp Phase I study with close monitoring of blood Glucose levels

3) different inhaler study

4) 24Hours Continuous Study of rivastigmine patch for Adhesion Scoring

5) Multiple Dosing of Ranolazine Study and Continue ECG Monitoring

6) Inj amphotericin b study conducted in Phase 01 ( With continue cardiac Monitoring )