Protocol Development and Study Design

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Customized Protocol Development: We work to develop protocols that address specific research objectives. Our team puts their efforts and extensive expertise to ensure well-defined study endpoints, comprehensive inclusion and exclusion criteria and appropriate statistical analysis plans.
Feasibility Assessments: We conduct assessments to evaluate the practicality and viability of study protocols in the Mexican and Latin American context. Our assessments consider factors such as patient population availability, regulatory requirements, logistical considerations, and site capabilities.
Optimized Study Design: Our team utilizes innovative study designs to maximize the efficiency and success of clinical trials. We apply principles of randomization, blinding, and stratification to minimize bias and optimize statistical power, resulting in reliable and meaningful study outcomes.
Endpoint Selection and Measurement: We assist in selecting relevant and clinically meaningful study endpoints and develop strategies for their accurate measurement aligned with regulatory requirements and capture the desired clinical outcomes effectively.
Statistical Analysis Plans: We develop statistical analysis plans that define appropriate statistical methodologies and endpoints to be used in the analysis of study data.

Ethics and Regulatory Compliance: We guide investors and investigators in understanding the regulatory landscape of Mexico. Our team ensures that study designs and protocols comply with local and international ethical guidelines and regulatory requirements.

At Althian, we are dedicated to delivering high-quality and scientifically rigorous protocol development and study design services in Mexico. Our expertise allows us to design studies that meet the needs of each research project while ensuring compliance with regulatory standards.

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.

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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.

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