Elevating Biopharma R&D

ICON was selected by a large biopharma company to partner across their core organisation to deliver FSP services in Study Management, Clinical Operations, Regulatory Affairs, Post Marketing Studies, and Data Management. ICON also supports the Sponsor’s Biosimilars organisation in a full-service capacity. The partnership began in 2006 in Study Management.

Due to the customer delivering R&D internally, ICON were posed with a number of challenges:

• The Sponsor uses FSP supplemental staff to deliver on priority goals and key trial milestones. However, decisions regarding resourcing are made by the Sponsor, meaning they need an agile CRO partner.
• The access to broader organisation is limited to category management and access to critical information on working environment can be limited.
• Sponsor seeks solutions that are comprehensive and address specific questions posed with limited insight.

ICON supports several crucial Sponsor development areas, including Study Management, Clinical Operations, Regulatory Affairs Post Marketing Studies, and Data Management. Through discussions with FSP teams at different levels, from functional to executive, ICON effectively delivers holistic solutions across its core business segment, (Including, Full Service, FSP, Operational Delivery, Development & Commercialisation and Symphony Health) Due to working with the Sponsor across multiple areas, ICON have created a non-siloed business unit to promote knowledge sharing and operational efficiencies in the following ways:

• ICON team forums scheduled weekly to discuss core metrics, engagement strategies and ongoing project status with commercial and executive teams.
• ICON teams are equipped with insights into commercial and operational strategies to engage in discussions with operational counterparts at the grassroots level. Our vision is to ensure that discussions at the operational level are guided by top-down Executive Steering Committee (ESC) meetings.
• Engagement strategies developed and deployed with actions catalogued by commercial team. Actions are followed up on to ensure completion and members are held accountable.
• Global meeting including VP of Customer Alliance and Executive Sponsor to discuss operational efficiencies at an account level.
• Power maps developed to generate insights on the wider Sponsor organisation
• Institutional knowledge shared by FSP team members supporting trial activity is cascaded to relevant groups across ICON to ensure consistent delivery across all areas.

ICON has generated a diverse set of services encompassing the entirety of the Sponsor’s delivery ecosystem, this has led to expansion across the following areas:

• Global Regulatory Affairs, Safety Submissions and Publishing, Clinical Trial Transparency
• Central, BioAnalytical and Specialty Labs
• Home health, site networks, DHTs and eCOA/eDelivery Solutions