Relationships Ensure Timelines
ARG has collaborated with a number of Immunologists in support of clinical trials. We value our long-standing relationships with several key investigators. Our continued partnership and positive track record of collaboration has resulted in meeting and exceeding enrollment timelines and recruitment expectations time and time again, not to mention efficiencies gained in site start-up activities.
Home Healthcare Drives Patient Centricity
The use of a home healthcare service to support patients transitioning from intravenous to subcutaneous administration is critical for the first few at home administrations. It allows patients to build confidence, teach the necessary skills associated with subcutaneous self-administration, and ensure early infusions are correctly administered.
We have also found that providing this as an option has been a great recruitment tool for sites.
Information Fosters Compliance
We ensure documentation that supports proper Investigational Product (IP) storage while in the patient’s home. Close coordination, monitoring and management of IP shipments directly to patient’s homes is key. We also recommend providing ancillary supplies for monitoring temperature, as well as a way to control IP during patient travel.
Patients appreciate options that allow flexibility to continue their day to day routine all while ensuring study compliance.
Children Need Accomodations
Providing an anesthetic cream for use by pediatric patients when inserting infusion needles has been well received in previous studies.
Communication Promotes Expectations
It is important to ensure transparent communication, as well as process consistency and compliance while performing activities related to site management and monitoring. We will create robust project plans that clearly define the expectations and workflow across all appropriate functional areas and team members.
We want any issue or concern raised at the site level to be shared across all CRAs so we can ascertain the same directive is being disseminated across all sites, This can be through a Newsletter and in a Q&A forum accessible within the communal system.
Technologies Strengthen Reporting
Managing data from multiple systems can be cumbersome. We recommend utilization of a Business Intelligence Platform (e.g. Spotfire) which will pull data from various systems and provide a project status summary report for the team. Spotfire is the platform ARG uses to extract study data from the eTMF, CTMS, and eCRF to create a project status summary report for the team to review and discuss during team meetings.