Dr Pratik Asari

MD Pharmacology professional with more than 10 years of experience across clinical research, BA/BE studies, Clinical trials, medical affairs, pharmacovigilance, medical writing, regulatory documentation, and medical device clinical evidence. Experienced in protocol and clinical report review, investigator responsibilities, ethics committee coordination, adverse event assessment, audit readiness, KOL engagement, scientific communication, and crossfunctional medical support for pharmaceutical, CRO, healthcare startup, medical device, and academic research clients.

MD Pharmacology Consultant - Independent Practice - Vadodara, Gujarat, India

Independent MD Pharmacology Consultant providing clinical research, medical affairs, pharmacovigilance, clinical trial, BA/BE, Medical & scientific writing, and healthcare research support for pharmaceutical, CROs and medical device sectors. Ethics Committee Member, Anand Institutional Ethics Committee of Anand Multispeciality Hospital, Vadodara.

Head - Clinical Research and Medical Affairs - Advanced MedTech Solutions Pvt. Ltd.

(2025-09 - 2026-05)

• Developed and supported clinical research strategy for medical device programs including clinical investigations, post-market surveillance studies, registries, and real-world evidence initiatives.
• Contributed to ISO 14155, ICH-GCP, CDSCO, MDR/FDA-aligned documentation, clinical evaluation reports, technical documentation, and regulatory approval support.
• Managed CRO, investigator, ethics committee, hospital, and academic institution interactions while monitoring study timelines, data quality, budgets, and deliverables.
• Led medical affairs activities including scientific communication material, evidence summaries, publications, training content, medical response documents, KOL engagement, CMEs, and medical review of promotional material.
• Supported publication strategy, manuscript development, abstract preparation, clinical data interpretation, adverse event reporting, and risk-benefit assessment.

Clinical Head and Facility Incharge; Principal Investigator - Accutest Research Laboratories (India) Pvt. Ltd. - Vadodara

(2021-07 - 2025-09)

• Managed clinical systems, facility operations, and study execution for BA/BE, clinical endpoint, PK-PD, and clinical trial studies.
• Reviewed feasibility, protocols, ICFs, CRFs, SOPs, clinical reports, amendments, study documentation, and ethics committee submissions.
• Oversaw planning, conduct, monitoring, reporting, subject safety, pharmacy responsibilities, randomization/code-breaking procedures, data quality, and document retention.
• Performed AE/SAE assessment and reporting, acted as medical expert/medical monitor when required, and ensured protection of subject rights, safety, and welfare.
• Handled sponsor audits, regulatory inspections, IEC interactions, monitor queries, CAPA support, and inspection readiness activities.

Clinical Research Scientist; Principal Investigator - Watson Pharma Private Limited, A TEVA Company - Navi Mumbai

(2020-01 - 2021-06)

• Planned, conducted, monitored, and reported clinical studies while maintaining clinical systems and facility compliance.
• Prepared and reviewed protocols, informed consent forms, CRFs, SOPs, clinical reports, IEC submissions, and amendments.
• Managed investigational product accountability, protocol training, delegation of responsibilities, informed consent, screening, subject eligibility, subject safety, and AE/SAE reporting.
• Supported sponsor, QA, IEC, and regulatory audits by providing documentation, responses, and study conduct clarification.

Deputy Manager; Investigator / Research Physician - Alembic Pharmaceutical Pvt. Ltd. - Vadodara

(2017-02 - 2020-01)

• Supported clinical facility management, study planning, protocol and study document review, IEC communication, SOP preparation, clinical report review, and study timelines.
• Managed informed consent, screening, subject eligibility, clinical assessment, investigational product accountability, AE/SAE recording and reporting, and subject safety oversight.
• Participated in audit and inspection activities involving sponsors, QA, IEC, and regulatory agencies.

Tutor / Resident, Pharmacology - Government Medical College, Baroda

(2015-02 - 2017-02)

• Performed academic, teaching, administrative, and departmental responsibilities for medical education at Baroda Medical College.

M.B.B.S.

• Government Medical College, Baroda; The Maharaja Sayajirao University of Baroda (2012)

M.D.

• Pharmacology - Government Medical College, Baroda; The Maharaja Sayajirao University of Baroda (2015)

Certificate in Industrial Health - Industrial Health - The Maharaja Sayajirao University of Baroda (2018)