Ruby Hall Clinic is a pioneer in the field of outsourced clinical research. We are proud to mention that our leading qualified consultants and experts in various specialties and subspecialties are trained in ICH/GCP guidelines and have a huge patient population. The Principal Investigator (PI) is responsible for conducting and supervising the conduct of a clinical trial and protect the rights, safety, and welfare of the subjects enrolled in the research. The responsibility of PI involves achieving the technical success of the project, while also complying with the financial and administrative policies and regulations associated with the trial.
Chest Medicine Urology
Ruby Hall Clinic is pioneer in the field of outsourced clinical research. We are proud to mention that our leading qualified consultants and experts in various specialties and sub specialties are trained in ICH/GCP guidelines and have a huge patient population. The Principal Investigator (PI) is responsible for conducting and supervising the conduct of clinical trail and protect the rights, safety, and welfare of the subjects enrolled in the research. The responsibility of PI involves achieving the technical success of the project, while also complying with the financial and administrative policies and regulations associated with the trial.
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.
- 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.
- 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.
- 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.