Our Re-monitoring Program continues to be important to the overall objectives of the company.   With a recent contract in Brazil, Argentina and Mexico, CRAs followed a specific re-monitoring plan at high enrolling sites.  The findings give the sponsor some assurance of the quality of the overall monitoring in a trial.

To facilitate the documentation of site visits, field CRAs were introduced to voice recognition software. The use of this software allows the CRA to document findings after reviewing each page of the case report form. This documentation serves the CRA in report completion, the study coordinator with data corrections and the clinical trial manager with any data collection issues needing special attention.

In an effort to expedite the flow of important information following routine site visits, a short version of the site visit report was introduced. The STAT visit report focuses on key information that is emailed to the sponsor within 24 hours of the site visit. This report can be processed securely with an encrypted email and electronic signature. The traditional Site Visit Report would still be provided at a later date.

To move forward with the long-term plan to conduct trials worldwide, CTI welcomes new advisors to the group.

Our first agreement was signed with a Japanese subsidiary in the United States to audit and re-monitor a pivotal clinical trial. This new agreement allowed CTI to validate the new program launched just a month ago.

CTI initiated a new program to focus on auditing and re-monitoring clinical data for pivotal studies. The focus will be on auditing clinical data, along with other quality assurance activities evolving from the program.

As with any new company, a website is an essential tool to reach potential clients about CTI’s mission, vision, services, and experience. The logo “Meeting the Challenges of Clinical Trials” was also an important step in defining the company’s focus.

Clinical Trials International (CTI) incorporated its business in the state of Nevada. Incorporating has several advantages over other business entities but more importantly the founders accomplished some of the major hurdles required in establishing the company.