Site Management Organisation
Orcigenix offers a complete spectrum service of Clinical Trial at site level. Highly experienced management with extensive clinical trial experience and qualified study coordinators help investigators to streamline each and every study activity. Orcigenix provides trained study coordinators who are capable to carry out clinical trial activities and ensure quality performance for every aspect of a trial. Our team is enabled to set up the entire clinical study including protocol development, site setup and management, rapid patient enrollment and study closeout/reporting.
We provide the following services:
• Site Identification and Feasibility
• Site Support Services
• Regulatory Service
• ICF Design
• CRF/eCRF Design
• Recruitment Strategies
• IRB/EC Submission
• Document Translations
• Contract & Budget Negotiation
• Patient Counseling
• Patient Recruitment & retention
• Subject safety Management
• Site initiation and trial close-out operations
• Trial-related documents archival and maintenance
• Reporting serious adverse events to the Sponsor or CRO and the IRB/IEC
• Ensuring protocol compliance
• Advising & alerting investigators of potential protocol violations
• Advising & alerting investigators of potential ICH-GCP violations
• Training
