Site Management Expertise

Anovus Clinical Research provides comprehensive site monitoring and management, including the assurance of protocol compliance, accurate data capture, and ICH-GCP compliance at investigative sites. Our Clinical Research Associates act as the bridge between the sites and the study team. Our CRAs are assigned to specific sites for the duration of the study to provide consistent support for sites. All monitoring activities are conducted in accordance with ICH-GCP compliance and data integrity during each site visit, consistently maintaining high quality, on-time data. Anovus Clinical Monitoring Team ensures the adherence with Standard Operating Procedures (SOPs) and strives to promote positive personal relationships with a high level of trust and confidence with all our customers. Anovus CRAs are both office and regionally based and are experienced in numerous therapeutic areas across Drug, Biologic and Device Trials.

Pre -Trial Operations
Site Feasibility Study
Ethics Committee Approval
Site Initiation
Tie-up with Clinical labs

Staff Recruitment and Training
Identification & Recruitment of Investigators
Clinical Research Coordinators & Associates
Adequate Manpower is available through Anovus Institute of Clinical Research

Patient Management
Patient Counseling
Patient Recruitment and Retention
Patient Follow up
Patient Safety

Compliance & Monitoring
Protocol Compliance
Monitoring Services
Quality Assurance
Site Initiation, Interim and Close Out Monitoring
Maintenance and storage of Trial related Documents
Audit Services
FDA Audits/Inspection Preparation
Undertaking and Complying with GCP & HIPAA regulations ensuring safety of human subjects

Documentation & Regulatory Submissions
Document Submission to IEC
Working/ Interacting with IEC
Translations of ICF in local languages
Reporting SAE’s to the Sponsor/ CRO
Regulatory Document Preparation and maintenance

Site Management    Medical Writing    CDM   Statistical Analysis    Pharmacovigilance   CDISC   Regulatory Affairs

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