Clinical Development & Bioequivalence
From BA/BE studies to complex clinical development programs.
Data Health supports pharmaceutical companies in defining and coordinating clinical, bioequivalence and bioanalytical strategies. We assess the product, target markets, regulatory requirements and operational complexity to identify the appropriate capabilities and support the project from initial feasibility through study execution and oversight.
Core capabilities
Bioequivalence and pharmacokinetics
Studies in healthy volunteers and patients, under fasting or fed conditions, with single or multiple dosing and conventional, replicate or parallel designs. Support for highly variable drugs, narrow therapeutic index products, fixed dose combinations, modified release products and complex generics.
Biosimilars and biologics
Clinical programs covering PK, PD, immunogenicity, ADA, NAb and biomarker assessments in healthy volunteers or patients, according to the product and regulatory strategy.
Oncology and complex products
Access to specialized capabilities for patient studies, oncology products, peptides, insulins, liposomal products, complex injectables and other formulations that require advanced clinical and bioanalytical expertise.
Bioanalysis and topical products
Method development and validation, LC-MS/MS, ligand binding assays, metabolite analysis, ISR, stability, IVRT, IVPT and vasoconstrictor studies.
Project coordination and oversight
Feasibility assessment, regulatory strategy alignment, identification and qualification of the required capabilities, technical and commercial interface, contract support and continuous project oversight.
Strategies are structured according to the product and target markets, considering the requirements of authorities such as ANVISA, FDA and EMA and, when applicable, the local regulatory interface required for international study conduct.
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Tell us what your project requires. Data Health will help identify and structure the capabilities needed to move it forward.