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althian

Early-Phase Clinical Trial Services

  • Phase I Clinical Trials: We conduct Phase I trials to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of investigational drugs in healthy volunteers or targeted patient populations. Our team designs customized protocols to determine optimal dosing, administration routes, and preliminary efficacy parameters. These studies are critical for establishing the clinical viability of new compounds.

  • Phase II Clinical Trials: Phase II studies confirm safety and gather initial efficacy data in specific populations. We collaborate with investigators to define meaningful endpoints and generate robust clinical evidence. Our adaptive designs and operational efficiency help sponsors make informed go/no-go decisions faster.

  • First-in-Human Trials: Althian designs and executes FIH studies with precision and care. These trials mark the first administration of a compound in humans and require meticulous planning, risk mitigation, and real-time monitoring. Our experience spans oncology, rare diseases, and advanced therapeutics.

  • Dose Escalation Studies:

    We offer expert support in dose escalation studies to identify the maximum tolerated dose (MTD) and establish safe therapeutic ranges. Our team uses stepwise escalation models and PK/PD simulations to guide dosing decisions and ensure patient 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.
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At Althian, we understand the critical role late-phase clinical trials play in generating robust evidence that drives informed healthcare decisions. Our expert team is committed to executing rigorous, efficient trials while upholding the highest standards of data integrity and participant safety.

Partner with Althian for trusted, efficient, and fully compliant clinical research services in Mexico. Connect with us today to explore tailored solutions and take the first step toward successful, streamlined clinical trials.

Expertise and excellence, delivering reliable, superior results

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

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