Role of clinical monitors in clinical research
Monitors are the heart and soul of clinical studies monitoring process. Acting as the primary channel of communication between the sponsor and the investigator, monitors have a crucial role to play in the clinical trials. For this reason, thoroughly trained monitors with right scientific and clinical knowledge are always a huge asset. Apart from assisting the investigators to make sure the trials are conducted and documented appropriately, monitors also verify the true existence of the information collected by cross-checking the source documents.
Monitors
In consideration of the study, Kaairosh will assign locally-based CRAs in the individual countries, who are familiar with their country regulatory requirements and ideally with previous experience monitoring global international clinical trials.
Our monitors are highly experienced in Phase I-IV clinical studies and proficient in multiple therapeutic area clinical trials. Each of them is adept in providing GCP-focused data review with flexible scheduling to ensure proper on-site time. Overall they ensure fast turnaround time for site visit reports.
Kaairosh monitors have considerable experience with both outpatient and inpatient records and procedure notes
Our monitors are also trained in control response reduction and the administration of questionnaires.
Our monitors perform on-site clinical trial monitoring visits throughout the length of the study to:
Oversee the collection of data
Review clinical laboratory results
Source case report forms and documentation
Resolve data queries
Oversee the collection of data
Confirm regulatory compliance
Training and Cultural Knowledge
Our clinical monitoring teams are well-equipped to deliver fast, efficient investigator site support and data oversight for your study. Kaairosh requires the CRAs to demonstrate proficiency in site monitoring before being allocated to a study and are mainly assigned to monitor sites in their home countries which provides the necessary understanding of local languages, regulations, customs and business practices.
Accelerate Database Lock
Since Kaairosh prepares the CRAs with study-specific training and who are familiar with local customs and regulatory requirements, this training and cultural knowledge improves site workflow management, reduce investigator burden, improve data quality and accelerate the database lock.
Our monitors are highly experienced in Phase I-IV clinical studies and proficient in analgesic clinical trials. Each of them is adept in providing GCP-focused data review with flexible scheduling to ensure proper on-site time. Overall they ensure fast turnaround time for site visit reports.
Kaairosh monitors have considerable experience with both outpatient and inpatient records and procedure notes
Our monitors are also trained in control response reduction and the administration of questionnaires.
The advanced clinical trial monitoring tools from Kaairosh add to our monitors’ capability to efficiently record and share the information with site-level staff
Our monitors perform on-site clinical trial monitoring visits throughout the length of the study to:
Oversee the collection of data
Review clinical laboratory results
Source case report forms and documentation
Resolve data queries
Oversee the collection of data
Confirm regulatory compliance