From study start-up to closeout, we've got you covered.
At Regulus Clinical we understand that managing a clinical trial is a complex, multifaceted process. That's why we offer a comprehensive suite of services designed to support you every step of the way.
What we do
Feasibility, Site Evaluation, and Selection
Assess potential sites for their capability to conduct trials, considering patient population, investigator experience, and facility resources.
Site Initiation and Management
Initiate and manage sites effectively, from Investigational Product (IP) release to interim monitoring visits and site closeouts, ensuring comprehensive data and IP reconciliation.
Patient Recruitment
Meet recruitment targets through effective site engagement and innovative strategies to boost patient recruitment as necessary.
Communication and Reporting
Maintain timely and effective communication with all stakeholders, including delivering visit reports and follow-up letters.
Bio-sample and IP Management
Oversee the management of biological samples, lab kits, and investigational products, ensuring proper handling and storage.
Protocol Compliance and Training
Ensure all site staff are fully trained on study protocols and any amendments, maintaining adherence through ongoing training.
Data Review and Verification
Monitor the accuracy and timeliness of data collection, uphold high standards of source data verification, and oversee adverse event reporting.
Document Management and Regulatory Compliance
Manage the Investigator Site File (ISF) and ensure all trial documentation is filed in the electronic Trial Master File (eTMF) in accordance with GCP and local regulations.
Liaison Work
Act as the key contact point between the sponsor, site staff, and investigators, facilitating communication and addressing study-related concerns.
Travel and Site Monitoring
Conduct on-site monitoring visits, traveling to investigational sites as required, and provide comprehensive reports to the sponsor and the Contract Research Organization (CRO).