Prashant Chorage Email & Phone Number

Pune, Maharashtra, India

Handling the team of 10 resources, resource management, work allocation, performance review, leave management, PDP objective and discussion, conducting team meetings, scrums, team huddles, project management, metrics reports and analysis, planned vs estimated report creation, client communication.

Pune, Maharashtra, India

• Develop an in-depth understanding of preclinical data• Develop an in-depth understanding of SEND and other regulatory standards/guidance• Perform reviews of preclinical data converted into SEND• Perform reviews for SEND compliance• Develop the ability to understand customer needs• Engage in additional SEND related consultancy services: SEND Education, SEND Consultancy, Dataset Verification, FDA Submissions, Services associated with clients implementing our Submit suite of products.

Mumbai Area, India

 Perform quality checks (QC) of indexed documents (Site, Country and Core), maintain the accuracy and consistency within e TMF. Review Essential Documents for completeness when required for Site Activation and keep them in audit ready state. Ensure project deadlines, commitments, and goals are met by monitoring project’s daily outputs. Perform complex process and task that eventually result in high quality deliverable that are completed according to service legal agreements (SLA’s) and within project timelines. Establish and maintain effective project/site communication for retrieving of regulatory package submission checklist documents (E-DP Checklist). Create and maintain relevant project documents in DIA Matrix. Ensure accurate completion and maintenance of internal system database, tracking tool, timelines and project plans with project specific information Participate in document management (Creation, review, maintenance, storage as applicable). Maintain and compile the errors, provide feedback for indexers on weekly basis. Track the priorities and deadlines for protocols which are for audits. Mentoring the indexing team and reporting weekly stats of indexing and Review-QC to management team.

Pune Area, India

 End to end indexing of site, country and core clinical documents i.e. from study start-up to study closure as per project specific metrics tool (e-TMF). Safety documents: SUSAR, PSUR, CIOMS, Med Watch, SAE reporting forms. Subject Specific: Inform Consent, Case Report Form, Subject Diaries, Source documents. Regulatory: IND, NDA, MOH-APP, Import-Export Licenses and GMP Manufacturing Licenses, Regulatory submission checklist (E-DP), Clinical study report (CSR). Product Specific: IMPD, COA, Bio analytical report,  Site Specific: Form 1572, FDF, CV's, CTA, CDA, Site Monitoring Reports, ICF, IP Shipment and IP-Release etc. Review of regulatory documents, publishing and formatting the documents, checking orientation, split and combining documents as per regulatory requirement, update internal trackers.

 Conducting the informed consent process giving information about the study to patient and taking the informed consent of the patient along with PI Scheduling visits of the patient according to the protocol requirements on visits documenting the vitals taken, physical examination performed, time of drug administration and route of administration as per the protocol in the source document Documenting the observed adverse events, appearance, its severity and concomitant medication Filling of the paper CRF's according to the details documented in the source document Documenting all the essential documents of the study in the source document and site master file

Mumbai Area, India

Conducted and monitored Bioavailability and Bioequivalence (BA/BE) Studies

M, Pharmacy

Masters of Pharmacy (Pharmacology)

B.Pharmacy Maratha Mandal'S College Of Pharmacy, Belgaum

Bachelor of Pharmacy-Pharmacology

Master'S Degree, Pharmacology And Toxicology

Organization Board/ University Year %

Bachelor'S Degree, Pharmacy

Bachelors of Pharmacy