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Clinical Operations

Planning, running and closing out clinical trials with strong site management, monitoring and quality oversight.

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Clinical Operations

Planning, initiation, conduct and completion of your clinical trials

Sigma-Chi clinical operations services refer to a range of activities and functions that support the planning, initiation, conduct, and completion of clinical trials or studies. These services are essential for pharmaceutical companies, biotechnology firms, contract research organizations (CROs), and other entities involved in clinical research.

Clinical operations services help ensure that clinical trials are conducted efficiently, ethically, and in compliance with regulatory requirements. Here are some key aspects of our clinical operations services.

Researchers working in a clinical laboratory
End-to-end support

Every stage of your study, managed

Study planning & design

  • Assistance in protocol development
  • Feasibility assessments

Site selection & management

  • Identification and evaluation of sites
  • Site initiation and training
  • Ongoing site management

Regulatory compliance

  • Support with submissions and approvals
  • Compliance with local and international requirements

Clinical monitoring

  • Monitoring for data integrity and subject safety
  • Source data verification and document review

Data management

  • Collection, validation and management of trial data
  • Database design and maintenance

Drug & device supply

  • Oversight of the investigational product supply chain
  • Distribution and tracking

Safety reporting

  • Adverse event monitoring and reporting
  • Safety reporting to authorities

Project management

  • Overall coordination of the trial
  • Timely progress reporting to sponsors

Quality assurance

  • Quality control measures
  • Audits and inspection readiness

Closeout & reporting

  • Study closeout activities
  • Final study reports
Healthcare worker in clinic
Quality and ethics

High-quality, ethical, guideline-compliant research

Companies providing clinical operations services may specialize in one or more of these areas, and they play a crucial role in facilitating the successful execution of clinical trials. These services help ensure that research studies are conducted with high quality, adherence to ethical standards, and in accordance with regulatory guidelines.

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