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Site Monitoring and Auditing

  • Site Monitoring Visits: We conduct regular site monitoring visits to ensure compliance with protocols, standards and standard operating procedures (SOPs). Our experienced reviewers analyze source documents for accuracy and completeness, review participant eligibility and informed consent, and perform data analysis for quality assurance.
  • Data Verification and Validation: We perform multiple data validation and validation processes to ensure the accuracy, completeness and consistency of clinical trial data. Our team compares source documents and electronic data entry systems, makes query decisions and ensures data integrity during the trial.
  • Protocol Compliance: We review site compliance with study standards, requirements and standards. Our team conducts regulatory audits, monitors compliance with the curriculum, and provides guidance to ensure compliance with procedures and accurate data.
  • Site Audit Support: We provide full support during site reviews by regulatory agencies, sponsors or Independent Review Boards (IRBs). Our team helps prepare documents, respond to audit findings, and implement Corrective and Preventive Actions (CAPAs) to support data compliance.
  • Site Performance Evaluation: We monitor site performance metrics, including sign-up rates, data quality and uptime. Our team identifies areas for improvement, provides feedback to site users and provides recommendations to improve site performance and overall success.
  • Training and Education: We provide training and education programs for site staff on Good Clinical Practice (GCP) guidelines, study guidelines and regulatory requirements. Our team ensures that site personnel have the knowledge and skills to perform testing according to industry standards.

Risk-based Monitoring Strategies: We implement a risk assessment strategy based on the needs of each study. Our team uses a combination of central monitoring, remote monitoring and remote monitoring systems to optimize resource allocation and improve data quality.

At Althian, we are sure that our experienced team will uphold the highest standards of compliance and data integrity.

Partner with Althian for reliable, efficient, and compliant clinical research services in Mexico. Contact us today to discuss your specific needs and start your journey towards successful clinical trials.


Clinical Trial Management and Coordination

  • Trial Planning and Design: Our experienced team works closely with investigators to design clinical trial protocols, ensuring adherence to international standards and regulatory requirements. We provide expert guidance in trial planning, including feasibility assessments, sample size determination, and statistical analysis plans.
  • Site Selection: We assist in site selection, evaluation and activation for clinical trials. Our rigorous site qualification process ensures the selection of sites with the necessary infrastructure, patient population and experienced investigators to conduct clinical trials.
  • Participant Recruitment: We employ targeted recruitment strategies to ensure efficient enrollment and retention of study participants. 
  • Clinical Data Management: Our robust data management systems and processes ensure accurate and secure collection, storage and analysis of clinical trial data. 
  • Regulatory Compliance and Ethics: We navigate the complex regulatory landscape of Mexico, ensuring compliance with local and international regulations and guidelines. Our team ensures ethical conduct throughout the trial, including obtaining necessary approvals from regulatory authorities and ethics committees.
  • Project Management and Monitoring: Our experienced project managers oversee all aspects of clinical trial execution, ensuring timelines, budgets, and quality standards are met. We conduct comprehensive monitoring visits to clinical sites, ensuring protocol adherence, data accuracy, and participant safety.

At Althian, we are committed to delivering exceptional clinical trial management and coordination services to advance medical research in Mexico. With our expertise, industry knowledge and regional insights, we provide tailored solutions to meet the unique requirements of each study.

Partner with Althian for reliable, efficient, and compliant clinical research services in Mexico. Contact us today to discuss your specific needs and start your journey towards successful clinical trials.

Expertise and commitment to excellence

Look no further than Althian, a leading company specializing in a wide range of clinical research services.

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