Balamuralidhar Hanumanthu Email and Phone Number

Authoring clinical trial protocols (Phase 1 to Phase IV) in the following therapeutic areas: Inflammation, Metabolic disorders, and Oncology.

Preparing Clinical Study Reports and Protocols.Developing SOPs and process documents.

• Preparation and QC public disclosure synopsis (PDS), Pharma Web Synopsis for posting on EudraCT, German Regulatory (BfArM) website and client website.• Preparation of Brief textual summaries (BTSs).• Enter client protocol information into the National Institute of Health (NIH) website (www.ClinicalTrials.gov), for interventional, non-interventional and expanded access studies. This includes the initial registration of protocols, as well as, amendment information that may need to be… Show more • Preparation and QC public disclosure synopsis (PDS), Pharma Web Synopsis for posting on EudraCT, German Regulatory (BfArM) website and client website.• Preparation of Brief textual summaries (BTSs).• Enter client protocol information into the National Institute of Health (NIH) website (www.ClinicalTrials.gov), for interventional, non-interventional and expanded access studies. This includes the initial registration of protocols, as well as, amendment information that may need to be added to the website.• Ensures Quality deliverables for the process. • Highlights any issues identified and proposes a solution or escalates to get appropriate resolutions. Show less

• Preparation and Review of documents for regulatory submission like Protocols, Clinical Study Reports (CSRs) and Case Report Forms• Preparing the Investigational Brochures • Preparation of Informed consent forms (ICF) based on the final protocol• Designing data collection forms, known as case record forms (CRFs)• Preparation of synopsis and feasibility reports for various molecules on sponsor request • Preparation of various study related documents like Investigator… Show more • Preparation and Review of documents for regulatory submission like Protocols, Clinical Study Reports (CSRs) and Case Report Forms• Preparing the Investigational Brochures • Preparation of Informed consent forms (ICF) based on the final protocol• Designing data collection forms, known as case record forms (CRFs)• Preparation of synopsis and feasibility reports for various molecules on sponsor request • Preparation of various study related documents like Investigator financial disclosures, undertaking by the investigator for different regulatories• Responding to the queries from Quality Assurance department, Sponsors and Ethics Committee (IEC) Show less