ARIANNE offers a full range of clinical study development and management services for all Phases (I, II, II and IV) of clinical research, outlined below. All procedures are controlled by Standard Operating Procedures (SOPs).
We work with experienced Investigators who have extensive research experience and highly trained staff. The average number of years of research experience for all Investigators is 7 years (e.g. United States). Each Investigator has conducted Phase II - IV trials and has a history of meeting and/or exceeding enrollment goals while maintaining quality data. In addition, each Investigator maintains a private practice in his/her therapeutic area of expertise (US). Enrollment goals are met through recruitment of private practice patients. Advertising is rarely used. Some sites have access to minority populations.
Sites have research experience is in the following areas, but not limited to:
Site Selection and Site Management (cont.)
Site Management is performed according to ARIANNE SOPs. ARIANNE conducts a monitoring visit when the first patient is dosed, then interim monitoring visits at agreed upon intervals for all site(s).
During onsite monitoring visits ARIANNE executes the following tasks to monitor compliance with GCP:
- Perform 100% review of all signed Informed Consent Documents
- Perform 100% source document verification of all key safety data
- Review all non-key clinical data at the site for legibility, completeness and consistency within the CRF set
- Instruct clinical site staff to supply missing data, complete data corrections, and clarify CRF information
- Check data clarifications against source documents to confirm that all clarifications have been made on the CRF and accurately reflect the source documents
- Monitor drug accountability, including the reconciliation of inventory
- Periodically review required clinical site regulatory documentation and provide updates to Sponsor
- Document deficiencies and follow-up until they are corrected by the clinical site staff
The monitoring visits are documented in Monitoring Visit Reports and follow-up letters are sent to the site. ARIANNE completes Monitoring Visit Reports and provides reports to Sponsor within 10 working days from visit, or as agreed to with Sponsor.
Site Management Services:
- Link Between Sponsor and Investigator (Site)
- Site Contract Management
- Obtain Local ECs/IRBs Approvals
- Regulatory Document Collection, Clearance and Update
- Preparation and Distribution of Newsletters
- Monitoring of Study Progress at Sites
- Oversee laboratory sample processing and shipments
For many clinical trials, local laboratories are used for the testing of routine laboratory samples. ARIANNE ensures that each local laboratory accepted for a clinical trial has the proper certifications and current reference ranges.
For more specialized testing, such as unusual tissue antigens testing, we assure the proper collection and safe shipment of samples to the central laboratories of sponsor preference.
ARIANNE conducts Site Qualification Visit(s) at selected clinical site(s). The Sponsor is welcome to participate in this visit. The site Qualification Visits are performed according to ARIANNE SOPs. ARIANNE completes a Qualification Visit Report for each site and provides the report to Sponsor within ten working days of the visit.