Dr.Prem Kumar Email & Phone Number

Greater Hyderabad

Conducted Pre-Study Site Visits (PSSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV),and study closeout visits, ensuring strict adherence to protocol, GCP, and regulatory requirements.Performed comprehensive Source Data Verification (SDV), ensuring data integrity and qualitythroughout the clinical trial lifecycle.Managed investigational product (IP) handling, including accountability, storage, distribution, andreconciliation, collaborating closely with pharmacy teams and vendors.Facilitated the preparation, translation, and review of informed consent forms (ICF), ensuringculturally appropriate translations and assisting with the informed consent process.Resolved data queries in Electronic Data Capture (EDC) systems, ensuring timely resolution ofdiscrepancies and liaising with relevant stakeholders.Provided training to site staff on IP-related procedures and handling to ensure compliance andpatient safety.Collaborated with cross-functional teams, including medical affairs and regulatory teams, for thereview and analysis of clinical protocols, Investigator’s Brochures, and other regulatorydocuments.Coordinated with investigators and pharmacovigilance teams to follow up on Adverse Events(AEs) and Serious Adverse Events (SAEs), ensuring compliance with safety reportingrequirements.Contributed to the preparation of Clinical Study Reports (CSR) and supported dossier finalizationactivities in collaboration with the medical affairs team.

Guntur, Andhra Pradesh, India

Collaborated with sponsors and principal investigators to ensure smooth execution of clinicaltrials in accordance with protocol, regulatory guidelines, and GCP standards.Coordinated patient screening, enrollment, and informed consent processes, maintainingparticipant safety and confidentiality throughout the study.Managed the Site Master File (SMF), ensuring accurate documentation of essential documents,including ethics committee approvals and regulatory submissions.Supported ethics committee submissions, preparing and organizing documentation for timelyapprovals, renewals, and amendments.Implemented rigorous data management practices, completing Case Report Forms (CRFs) andresolving data queries in EDC systems such as Medidata, Rave, Inform, REDCap, and Octolsoft.Conducted data quality checks and supported principal investigators in resolving datadiscrepancies, ensuring high standards of data integrity.Acted as the primary liaison between investigational site and sponsors, addressing sponsorrelated queries and facilitating site visits.