Study Team
Our study team comprises of Site Startup Specialists, Quality Assurance(QA) Managers, 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.
