Process

The process of building a clinical study:

After an initial meeting to understand the clients needs and vision, we begin by creating a potential list of principal investigators (PIs) and feasible sites for the specific study. We work with PIs who are key opinion leaders in  their field, have significant experience in conducting clinical research, and have sufficient qualified staff members on their team, all of whom must have GCP qualification.

When reviewing a site, we pay special attention to insure the prospective site has the necessary equipment for conducting the trial, all equipment is properly calibrated, temperatures are monitored frequently, there is sufficient space for conducting study procedures, and  there is adequate storage for the IP (Investigational Product), and other study supplies.

Site selection:

Once a site is reviewed and found adequate for a trial, the next step we provide is creating trial documents and preparing them for submission to LECs and RA. Documents will include Protocol, Investigator Brochure, Informed Consent Forms, etc., all while making sure to adhere to the GCP principles, LEC and RA requirements and regulations.

After site selection, we contact a lawyer to prepare contracts, as well as an insurance company to create insurance policies for the study. We develop budgets for each site according to the negotiated agreements.

We also contact clinical supply companies that can provide the required equipment, sample collection kits, and investigational product.

Preparing selected sites for study initiation:

We ensure all study equipment arrives at the site prior to site initiation and staffs GCP certificates are all up to date. At this stage, we ensure all equipment is properly calibrated and temperatures are monitored. Review of study documents and regulatory approval is performed prior to IP release.

Site initiation:

At site Initiation site staff training on study conduct is performed. A final review of the sites facilities and documents is done as well. Once the site is confirmed to be ready, green light for enrolment is given.

Monitoring:

Study monitoring is a process of quality review of the study conduct by the site. Our experienced monitors visit the sites on agreed upon intervals to review enrolled subject data for data validation, study documents and staff qualification, adherence to protocol and that all other study requirements continue to be in place throughout the study.

Data collection:

Study data is reported by the clinical sites and collected by our selected quality data collection platform. Data is reviewed thoroughly to insure accuracy of reported data.

Site close-out:

The process of site close out includes final review of study and site documentation, data reconciliation, final collection of study equipment and supplies and preparation of archival storage.

Report of results and conclusions:

Final report preparation is done with full consultation and review of the clinical team followed by the expertise review of the regulatory lead to prepare for RA submission.