Early-Phase Clinical Trial Services

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Phase I Clinical Trials: We offer Phase I clinical trials to assess the safety, tolerability, and pharmacokinetics of investigational drugs in healthy volunteers or specific patient populations. Our team designs and conducts comprehensive Phase I studies to determine optimal dosage, administration routes, and preliminary efficacy data.
Phase II Clinical Trials: We conduct Phase IIa clinical trials to evaluate the preliminary efficacy and safety profile of investigational drugs in specific patient populations. Our team collaborates with investigators and sites to execute well-designed Phase IIa studies, providing valuable insights for further development decisions.
First-in-Human Trials: We specialize in conducting First-in-Human (FIH) trials, which are crucial for evaluating the safety and pharmacological effects of novel compounds in humans for the first time. Our team ensures meticulous planning, ethical considerations, and stringent safety monitoring throughout FIH studies.
Dose Escalation Studies: We perform dose escalation studies to determine the optimal dosage range for investigational drugs. Our team employs sophisticated study designs, such as modified Fibonacci or accelerated titration designs, to guide dose escalation decisions while maintaining participant safety.
Biomarker Development and Validation: We collaborate with clients to identify and validate biomarkers that can be utilized as indicators of drug response or safety. Our team conducts robust biomarker studies to provide valuable insights into the mechanism of action, patient stratification, and response prediction.
Data Management and Biostatistics: We offer comprehensive data management and biostatistics services for early-phase clinical trials. Our team ensures data integrity, performs statistical analysis, and generates accurate reports, supporting evidence-based decision-making.
Regulatory Compliance Support: We provide guidance and support in navigating regulatory requirements for early-phase clinical trials. Our team assists in protocol development, study design, and regulatory submissions, ensuring compliance with local and international regulations.

At Althian, we recognize the importance of late-phase clinical trials in generating robust evidence to inform healthcare decisions. Our experienced team is dedicated to conducting rigorous and efficient trials while maintaining the highest standards of data integrity and participant safety.

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.

althian

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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