The Clinical Research Associates (CRA’s) of the Company are experienced, qualified professionals and attentive employees who adapt fast to the requirements of any new study. CRA’s are all medical doctors, pharmacists, and other medical professionals with university diplomas. CRO Biomapas CRA’s have successfully monitored studies in various phases of product development for world leading pharmaceutical companies, such as GSK, Johnson&Johnson, Shering-Plough and others.
Every new CRA passes an introductory in-house programme that includes study of the internal Company regulations, Standard Operating Procedures (SOPs), Good Clinical Practice (ICH GCP) principles, and appropriate EU directives. The Senior CRA and Quality Assurance Manager supervise CRAs in their studies and perform co-monitoring and inspections. This practice ensures quality monitoring of a project in compliance with study protocol requirements and SOPs. At Sponsor request, visits and audits are always welcome.
In addition to monitoring activities, CRO Biomapas CRA’s can handle all in-house study tracking and site management functions, such as
- study recruitment tracking
- pharmacovigilance, including SAE notification to the EC/Competent authority
- coordination of drug and material shipments for a study