Patient Safety
Data Integrity
Ophthalmology Specific
Our team has decades of experience in the development, coordination and completion of human clinical trials of all phases and sizes.
Our Services
CTRG is experienced at all levels from site, to sponsor, to regulatory, and everything in between. We work collaboratively with you to identify obstacles before they are encountered, maximizing efficiency and accelerating your development timelines.
Protocol Consultation
Provide expertise, guidance and support for development of protocols for Phase I, II, III, and IV clinical trials as well as investigator- initiated studies.
General Study Oversight
CTRG oversees every aspect of the trial from site management, regulatory submissions, accounting management of trials to paying vendors and reconciling invoices for sites to the Sponsor.
Site Management
Site management is needed during pre-study activities such as feasibility collections and site qualifications.
Trial Master File (TMF) Maintenance
CTRG maintains a Trial Master file for every study. A trial master file contains essential documents for a clinical trial that may be subject to regulatory agency oversight.
Remote Monitoring
Remote Monitoring is performed using an electronic CTMS system.
Regulatory Preparation
The ICH GCP Guidelines define Essential Documents as those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of data produced.
Source Documentation Preparation
CTRG creates Source document templates to be utilized by all sites allowing all participating sites in the trial to know exactly what data to collect and how to collect it.
Safety Reporting and Management
Monitoring patient safety is an integral and critical part of the clinical trial process.
Data Dissemination
Provide strategic advice on presentation and publication planning as well as scientific input into development and presentation of data.
CTRG Studies
CTRG has extensive experience with Phase 1 through 4 pharmaceutical as well as medical device studies. Committed to the success of your clinical trial development program.
For more information, please contact us at info@clinicaltrialsresourcegroup.com