Clinical monitoring

iPharma specializes in monitoring services within clinical trials. Our qualified monitors (CRA) have extensive experience and regularly improve their qualifications by following the principles of good clinical practice (GCP) and internal company standards. Most of our staff have specialized education in medicine, pharmacy or biology.

Monitoring, as defined by the GCP manual, is a process which ensures supervision of the clinical trial process, collection and presentation of data in strict compliance with the protocol, standard operating procedures, GCP and government requirements.

An individual monitoring plan is developed for each study, which includes all key aspects of monitor activity, such as the frequency of visits, report volume, training and communication methods, as well as record procedures for medical substances and study materials. Our specialists regularly visit study centers on all stages of research.

During visits, which can be accompanied by the Sponsor’s representatives, the monitor develops a thorough report for each visit, which is forwarded to the Sponsor after a verification by the project manager. Visit summaries are also presented in the form of a summary letter for the principal investigator and the center team.

Main types of monitoring visits:

Centre selection visits

the assessment of the center’s compliance with trial conduct criteria
1

Centre initiation visits

the preparation of the center for study initiation and training of center personnel
2

Monitoring visits

the verification of compliance with study protocols and data accuracy during the entire study process
3

Center closure visits

study completion, data verification and preparation to archive the data
4

Monitoring also involves remote supervision of the study process, which is conducted by electronic data storage systems and the central laboratory, as well as by information provided by the research centers. If necessary, a monitor who works remotely and maintains communication with centers is included in the project.