Large Molecule

Pharmacokinetics by immunoassays

Project Management

  • At Cliantha Research, our dedicated Project Managers act as your central point of coordination throughout the study lifecycle. Each Project Manager brings strong scientific expertise and extensive industry experience, ensuring that project goals including timelines, deliverables, and budgets are consistently achieved. They stay closely involved in data interpretation, provide timely study updates, and offer strategic recommendations, enabling seamless project execution and well‑informed decision‑making.

Method Development

  • With deep experience in regulated large‑molecule bioanalysis, Cliantha Research specializes in the design, development, and optimization of robust immunoassay‑based bioanalytical methods. We collaborate with sponsors to select and customize assay formats based on scientific requirements, ensuring a smooth progression into method validation.

Method Validation

  • Our method development laboratory teams work in close partnership to facilitate a streamlined transition from development to validation. Prior to formal validation, each method undergoes comprehensive pre‑validation assessments to confirm ruggedness, reproducibility, and regulatory alignment. We conduct in‑house cut‑point statistical analysis, prepare essential reagents, and follow current industry and regulatory guidance to ensure your methods meet stringent scientific and compliance standards.

Sample Analysis

  • Cliantha’s large molecule bioanalysis laboratory is equipped with advanced immunoassay platforms, including MSD, ELISA, Fluorescence/Chemiluminescence (FL/CL) and flow cytometry platforms. Our team is capable of supporting studies with demanding turnaround times while maintaining the highest level of data quality and scientific integrity.

Sample Management

  • Our sample management team has extensive experience handling large sample volumes under accelerated timelines. Every sample is processed with meticulous care beginning with receipt and continuing through storage, tracking, and final disposition. We maintain strict chain‑of‑custody procedures and operate under robust SOPs covering reagent quality, equipment metrology, and raw data controls, ensuring complete traceability and compliance.

Medical Writing Support

  • Cliantha provides comprehensive medical writing support for bioanalytical studies, including the preparation of sample analysis reports, method validation reports, and other regulatory‑driven documentation. Each report undergoes multiple levels of scientific and quality review and is typically delivered within 2–5 weeks following final data QC, ensuring clarity, consistency, and regulatory readiness.
  • Value to you: Reliable exposure data to guide critical development decisions

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