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Williams Design and its Applications within Clinical Trials

Williams Design and its Applications within Clinical Trials

Repeated measures design has been widely used in the early phase hap study, such as the two-way crossover design for a regular Bioequivalence study. Since the same subjects receive multiple measures, one obvious advantage of the repeated measures design is that fewer...

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Drug-Drug Interactions in Clinical Research

Drug-Drug Interactions in Clinical Research

A drug-drug interaction (DDI) is a reaction between two (or more) drugs. A DDI can have pharmacology effect and Pharmacokinetic (PK) effect. The pharmacological effect of one or both drugs may be increased or decreased, or a new and unanticipated adverse effect may be...

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The Role of a Clinic Pharmacy within a CRO

The Role of a Clinic Pharmacy within a CRO

The clinic Pharmacy within a Clinical Research Organization (CRO), plays a fundamental role in the successful execution of a study. In collaboration with the trial sponsor, and the entire BioPharma Services team, the clinic pharmacy is involved from the beginning of...

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Bioanalytical Method Validation Focus on Sample Stability

Bioanalytical Method Validation Focus on Sample Stability

Bioanalytical method validation is performed to demonstrate that a given method is suitable for its intended use, i.e., in the quantitative analysis of drugs, metabolites and biomarkers in biological matrix (plasma, serum, urine, etc.). This is achieved by performing...

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Corrective Action Preventive Action (CAPA) Best Practices

Corrective Action Preventive Action (CAPA) Best Practices

What is a CAPA (Corrective Action/Preventive Action) and why? A CAPA is a comprehensive investigation generated to address a systemic quality incident and is mandatory in resolving/preventing the issue from recurring. In order to have an adequate CAPA process, the...

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