We provide clinical trial services that are tailored to our clients’ needs. Our menu of available services is below, which can be customized depending on the demands of the study.
Site Identification and Study Initiation
We will work with study sponsors to identify and overcome logistical obstacles to successful study implementation. We will select appropriate outpatient or inpatient settings for performing studies within our hospital network.
Study Staff Identification
We will identify appropriate investigators at the University Medical Center hospitals to conduct the research. We will also identify study coordinators, nurses, pharmacists and other needed staff.We will arrange the needed staff for obtaining informed consent; interviewing and examination of participants; performing phlebotomy and other study-dictated procedures; participant/family education; follow-up.
Budget and Financing
We will perform an evaluation of the costs of performing the trials and act as a one-stop center for negotiation of budgets. We will coordinate all aspects of budget implementation. This will include facilitation of the orderly flow of study revenues from sponsor to hospital and distribution to investigator, study staff and hospital ancillary services.
Study design consultancy
We can provide consultancy services to develop study protocols and perform statistical analyses through our Nazarbayev University Faculty network in Astana and internationally.
Our staff has a deep understanding of regulatory requirements in Kazakhstan for clinical trial regulation and approval. We will complete and submit required regulatory documents according to Kazakhstan law. We will maintain appropriate documentation in study binders.
Submissions to Ethics Committee(s)
Our staff has extensive understanding of both local and international ethical requirements. We will submit protocols, consent forms, advertisements; protocol amendments, adverse events reports, and other necessary documentation to the required IRB committee(s). The Nazarbayev University Ethics Committee follows international standards for ethics review processes.
Coordination of ancillary services (pharmacy, laboratory, radiology)
We will coordinate the ancillary services for each study and establish mechanisms for routing of participants,medications and laboratory specimens.
We will develop plans with investigators for advertising to potential participants/families; identification of potential participants; informing potential participants/families about studies.
Case record form maintenance
We will ensure proper documentation of demographic data, history, examinations, laboratory results, symptom diaries, medication records, follow-up and resolution of data inquiries.
We will provide data entry services where needed into computerized databases.
Interfacing among sponsors, clinical research organizations, monitors, and local investigators
We act as a hub for communications between the study sponsor, clinical research organization, site monitors, and investigators. We will facilitate the visits of site monitors from earliest contact about a study until study termination; assistance to site monitors during site initiation, monitoring, and study closeout visits.