Suyog Surve Email and Phone Number

Compilation of the study related documentsEnsuring the conduct of the trials as per the ICH GCP & Protocol Specified guidelinesRecruitment & Retention of patientsAssist in the process of administering the informed consent to potential patients and discussing in detail the patient information sheetFollow up with site team for timely completion of the Source Documents and ensuring that all the relevant information required in the Case Record Form are present in the source documentComplete the Case Record Forms within the timelines and with minimal errorsSchedule subject visits as per the protocol to ensure maximal subject compliance retentionCoordinate all lab related activities - shipment of samples through the designated courier and ensure timely receipt of the lab reportsCompile and update the Trial Master FileMaintain the study related logs i.e. screening, enrolment, drug administration, temperature and other communication logsResolution of monitoring issuesCommunication with Sponsor regarding any issue related Study.Reporting of SAE to Sponsor within timelineCommunication with Sponsor, Project Manager regarding any trial related issues and corrective action.Manage the accountability of the Clinical Trial MaterialCoordinating Ethics Committee Submission & ApprovalCoordinate for any query from the Ethics CommitteeFilling of e-CRF and quick DCF resolution.

Pharmacovigilance-DSS (Process Executive Data); Performing duplicate search, booking the case into Client’s corporate safety database, e.g. Argus, and attaching the AEM form to the case and then routing the case for data entry.Retrieving the cases by generating the appropriate work list.Completing data entry of the data contained in the source documents using appropriate mapping documents.Identifying invalid cases and assigning it properly for HCP verification and further validity assessment.Doing Peer review for data entered.Keeping the work log updated and completing the requisite trackers.Performing review of ‘Electronically Unblinded Cases of Clinical Trial’.Performing ‘Manual Unblinding of Clinical Trial cases’