ARIANNE offers a full range of clinical study development and management services for all phases of clinical trial research (I, II, III and IV), outlined below. All procedures are controlled by Standard Operating Procedures (SOPs).
Site Selection and Training
ARIANNE conducts Site Qualification Visit(s) at selected clinical site(s). The site Qualification Visits are performed according to ARIANNE SOPs and Sponsors are welcome to participate in these visits.
We will perform:
- Identification and evaluation of adequate sites
- Identification and recruitment of experienced investigators
- On-site training of clinical personnel (clinical research coordinators and/or investigators)
- Financial negotiations with sites and investigators and additional third parties (laboratories, radiology centers, etc.)
We work with experienced Investigators who have extensive research experience and highly trained staff. Each Investigator has conducted clinical trials and has a history of meeting
and/or exceeding enrollment goals while maintaining quality data. The average number of years of research experience for Investigators varies from one country to another. In addition, in the United States, some of these investigators may maintain a private practice in his/her therapeutic area of expertise.
Sites have research experience is in the following areas, but not limited to:
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Site Management
Site Management is performed according to ARIANNE SOPs. ARIANNE conducts monitoring visits at regular intervals per sponsor requirements. The first visit is often conducted when the first patient is dosed, then interim monitoring visits are conducted at agreed upon intervals for all site(s).
During on-site 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 and provided to the sponsor.
Site Management Services:
ARIANNE acts as the link between the sponsor and the investigators/sites. Our responsibilities include, but are not limited to:
- Regulatory document collection, clearance and update
- Obtain local ECs/IRBs approvals
- Regular and ongoing communication with the sites to follow study progress
- Maintain study binder on site
- Ensure site compliance to study and regulatory requirements
- Oversee integrity and quality of data
- Assure patients safety
- Preparation and distribution of newsletters
- Oversee laboratory sample processing and shipments to third parties when required
- Oversee drug requests, shipments and receipts
- Ensure adequate availability of study supplies at sites
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, study specific biomarkers, we assure the proper collection and safe shipment of samples to the central laboratories of sponsor preference.