Study Team

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Ethics committeeOur study team comprises of Site Startup Specialist, Quality Assurance(QA) Manager, Clinical Research Coordinators (CRC) and Clinical Research Nurse along with Principal Investigator(PI) and Sub-Investigator (Sub-I). Our study team is trained in ICH/GCP guidelines for effectively conducting a clinical trial. We are totally committed, passionate & experienced individuals who oversee & coordinate the timely execution of trial. We assure complete trial subject safety & confidentiality. We undertake in-house training of regulatory & study specific updates at regular intervals.

SITE START UP SPECIALIST

  • Facilitates start-up activities including site identification, feasibilities, document collection and review, ethics and regulatory submissions, site agreements and budgets.
  • Collect, review, process, and track regulatory & investigator documents required for study site activation in accordance with site SOPs, sponsor SOPs, ICH GCP guidelines & Regulations.
  • Works with IEC/ Regulatory authorities as appropriate regarding amendments and queries related to start up activities.
  • Conduction & coordination of site identification, site selection to site initiation visits.

QUALITY ASSURANCE [ QA ] MANAGER

  • Conducting quality reviews of protocols, CRFs and supplemental study documents.
  • Facilitate system audits, audits of trial processes and assisting in preparation for sponsor, DCGI & regulatory inspections and audits.
  • Updating & reviewing data listings and study reports.
  • Conduct internal process audits to assess compliance with SOPs, ICH GCP and regulatory requirements.
  • Coordinating and conducting clinical research training programmes.
  • Identification of areas for continuous quality improvement and leading the organization in implementing these improvements.
  • Identifying and correcting quality issues & highlight systematic issues that can impact on the quality of the trial as a whole & their resolution within timelines.
  • Interfacing with ethics committee, regulatory agencies, sponsors and independent internal auditors.
  • Updating the study team for new developments regarding guidelines, procedures and SOP’s.
  • Prompt corrective and preventive actions to significantly improve the overall quality of the study data & for smooth functioning of the trials.

CLINICAL RESEARCH COORDINATOR [CRC]

Study specific functions of CRC’s -

  • Assist Site assessment, site start up, Site initiation, site monitoring, audits & closeout.
  • Institutional Ethics Committee document submission.
  • Informed Consent Form Process – Assist the PI in obtaining informed consent from the trial patient and explain the merits and demerits of the study.
  • Source Documentation -Document data pertaining to the patient.
  • Case Report Form (CRF) Filling & Query resolution - Record accurate data into CRF and resolve all the queries.
  • Safety Monitoring & Reporting - Report all adverse events and serious adverse events to the Sponsor/CRO/IEC in the respective timelines.
  • Investigational Product (IP) Management & Accountability - Manage the IP at the site according to trial specific requirements.
  • Filling of Logs - Timely filling of trial-specific logs.
  • Patient Visit Scheduling- CRC will keep a visit tracker and schedule all patient visits.
  • Study Updates - Update the trial monitor as and when required.
  • Correspondence with CRO/Sponsor
  • Handling of study specific logistics.
  • For every trial, along with the primary CRC, a backup CRC is available for smooth functioning of trial.
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