Our Services

Ariem Consulting Group delivers specialized, independent services to sponsors, Contract Research Organizations (CROs), clinical research centers, and other stakeholders in the clinical research and pharmaceutical industries. Below is a comprehensive summary of our services, presented professionally to highlight our expertise.

Quality Assurance Auditing

• GCP Audits:

  • Comprehensive audits of clinical trial processes and clinical research sites to ensure adherence to GCP standards.

  • Risk-based audits to focus on critical trial elements, such as patient safety and data integrity, in alignment with ICH E6(R2) guidelines.

Inspection Readiness and Training

• Inspection Readiness:

  • Mock inspections to simulate regulatory audits by agencies such as the FDA or sponsors, identifying potential issues and preparing teams for real inspections.

  • Support for inspection hosting, including document preparation, staff coaching, and response strategy development.

• Training Programs:

  • Customized training on GCP, requirements for clinical trial teams, investigators, and support staff.

Clinical Research Center Support

• Startup & Business Development :

  • Customized consulting services to support the establishment and expansion of clinical research centers, delivering strategic guidance and operational expertise to meet your unique needs. From launching a new facility to scaling operations for sustained growth, our solutions drive success at every stage of your business journey.

  • Budget and Contracting Support

  • Staff Hiring Support

  • Writing and Implementing SOPs

  • Source Document Creation

  • Quality Check and Assurance

  • Optimizing current processes for efficiency and effectiveness