About Site Management Organization

Imperial Clinical Research Services based in India, is a well-known organization in the field of clinical research, offering a variety of services to support clinical trials for Pharmaceuticals, Herbal, Nutraceutical safety Studies, Cosmetics, Personal care products. As a Site Management Organization (SMO), Imperial provides comprehensive site management services designed to facilitate the efficient and compliant conduct of clinical trials. Here are some key aspects of Imperial Clinical Research Services.

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Site Management and Monitoring

Imperial offers site management services that include site selection, initiation, monitoring, and closeout. They ensure that clinical trial sites are compliant with regulatory requirements and study protocols

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Regulatory and Ethical Compliance

They assist in preparing and submitting necessary regulatory documents and ensure that all activities are conducted in accordance with Good Clinical Practice (GCP) guidelines and local regulatory requirements. This includes liaising with Institutional Review Boards (IRBs) and Ethics Committees (ECs).

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Patient Recruitment and Retention

Imperial provides strategies and support for patient recruitment and retention, crucial for the timely completion of clinical trials. This includes identifying potential patients, managing patient databases, and implementing retention programs.

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Clinical Operations and Study Coordination

They offer trained clinical research coordinators and associates who manage day-to-day clinical trial operations. This includes scheduling patient visits, managing informed consent processes, and ensuring accurate data collection and entry.

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Investigator and Staff Training

Imperial provides training programs for investigators and site staff on study protocols, regulatory requirements, and best practices in clinical research. This helps ensure that site personnel are well-prepared and knowledgeable.

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Quality Assurance and Control

The organization implements rigorous quality control measures to ensure data integrity and patient safety. This includes conducting internal audits, monitoring visits, and implementing corrective and preventive actions (CAPAs) as needed.

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Data Management and Reporting

They offer data management services, including electronic data capture (EDC) systems, data entry, and verification. Imperial also handles the preparation and submission of required reports, such as safety reports and progress updates.

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Logistical and Administrative Support

Imperial provides logistical support to clinical trial sites, including managing supplies, coordinating shipments, and handling administrative tasks. This allows investigators to focus on patient care and study oversight.

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Financial Management

They assist with budgeting, financial planning, and management of trial-related expenses. Imperial ensures that sites are compensated fairly and promptly for their participation in clinical trials.

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Communication and Collaboration

The organization facilitates effective communication between sponsors, sites, and other stakeholders. This includes regular updates, meetings, and maintaining open lines of communication to address any issues that arise during the trial.

Overall, Imperial Clinical Research Services offers a comprehensive suite of services aimed at supporting clinical trial sites, ensuring compliance, enhancing efficiency, and contributing to the successful execution of clinical trials. Their expertise in site management helps sponsors achieve high-quality data and reliable trial outcomes.

The scope of services that we offer includes

Feasibility assessment and site selection

Site Management and Operation

  • Subject recruitment strategies, retention and Safety management
  • Ethics Committee and Regulatory submissions
  • Site contract, budget, expense management
  • Third party vendor management
  • Clinical Operations Support /GCP documents / Ensuring Study compliance
  • GCP documents / training review
  • Monitoring and auditing support.
  • Quality Control
  • Language translation services
  • ICH-GCP training
  • CRC/Study Nurse/Phlebotomist recruitment

We would be happy to associate/Partner with you and compliment you in your endeavours with some of our reliable services.