CRCI specializes in establishing, operating and managing international investigative sites so as to successfully implement clinical trials pursuant to the specifics of a particular clinical trial protocol.  This premier service combines CRCI’s global site network with expertise in implementation to provide an efficient, effective, and accurate clinical trial.  Whether you want to use our sites, or you just need some monitoring or training, CRCI will help you navigate your way through clinical trials in ascending markets.

Sites

CRCI, through its global connections, operates investigative sites in various locations throughout the world. Each location is chosen based on availability of professional investigative staff as well as access to large, diverse patient/volunteer  populations.  Following are some of the ways that CRCI, the parent company, supports its local affiliates.

• CRCI ensures that all local requirements and regulations are met with regards to matters at both a national and local level
• CRCI assists the local site in setting up the requisite infrastructure as dictated by the trial at hand
• CRCI provides training of the local investigative staff as to the manner and processes necessary to fulfill each trial’s requirements
• CRCI audits and monitors the ongoing performance of each investigative site so as to ensure standards required by the sponsor and the FDA in accordance with good clinical practice
• CRCI, through its training, quality control and auditing of the investigative site, ensures that research will comply with standards imposed by the drug companies and their CROS.

Clinical Trial Implementation

CRCI gives CROs and Sponsors access to investigative sites in ascending markets on a global basis.  Moreover, CRCI, provides both the drug companies and their CROs ‘one stop’ shopping services with regards to the activities relating to the clinical trial's segment of the drug development process.  CRCI moves drugs through the clinical trial process quickly and efficiently, thus reducing the time to market.  The following list includes some of the services that CRCI provides to pharmaceuticals and CROS.

• CRCI leverages the experience gained in the USA in order to provide access to a global network of investigative sites. This experience ensures the professional manner in which these trials are conducted and provides the requisite training and support in order to meet the needs of a given clinical trial protocol.
• Additionally, CRCI leverages its global experience in sourcing the investigative site in a location that has access to patients and volunteers participating in the trial, as well as qualified investigators well versed in good clinical practice.
• CRCI contracts with the Drug Company’s CRO with respect to a given trial.
• CRCI, in consultation with the Sponsor, will source the trial to a specific investigative location.
  
• CRCI will work with the local investigators to ensure the quality of initial training with respect to the specifics of the trial at hand.
• CRCI will provide support to the investigative site throughout the trial.
• CRCI will facilitate direct communication between the investigators and the sponsors as required by the sponsors.
• CRCI will oversee and coordinate the implementation of the trial through a specific set of activities designed to ensure the most efficient, cost effective, and accurate results.

CRCI will:  

• Receive and review potential research protocols
• Implement site profile to fulfill a specific protocol Assess site suitability for profile of study volunteers based on inclusion/exclusion criteria specific to protocol
• Develop budget to conduct a trial
• Approve suitability of site to meet protocol’s requirements
• Prepare site infrastructure needs for specific trial
• Implement reporting procedures
• Assess training requirements for a particular protocol
• Conduct site related training
• Recruit potential study volunteers pursuant to inclusion/exclusion criteria
• Obtain Institutional Review Board (IRB) or equivalent approval
• Administer study medication and medical testing
• Record results of medication using requisite reporting formats
• Audit progress of trial
• Audit implementation of GCP ( good clinical practice – FDA guidelines)
• Host drug company/CRO monitors on site
• Monitor progress of trial
• Update Drug Company/CRO on progress
• Assess effectiveness of manner in which trial was conducted

The services provided by CRCI are unmatched by any known competitor in the
marketplace.