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...
First in Human Clinical trials (FIH trials) play a critical role in bringing investigational new drugs or interventions to the clinical practice. To ensure the safety of study participants, FIH trials are preceded by preclinical tests in in vitro and in vivo...
The Pre-IND meeting is a critical meeting for any sponsor wanting to pursue a new drug approval (NDA) in the United States. With the ultimate aim to get the first approval of a drug in the large US market, it may seem logical and advantageous to start the process in...
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...
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...
BPSI’s success story using normal healthy volunteers for Cost-efficient clinical development of a generic or improved formulation of oncology drug(s)Introduction Growing concerns about the high number of cancer-related mortality have increased the demand for oncology...
