Governance and quality

2021 saw a restructure and investment in Icon’s governance team to streamline study start-up framework and centralise support across feasibility, ethics and trial contracts.

Newly appointed Global Research Governance Manager, Tenille Baker has brought a new level of expertise to the Group’s global governance procedures and has introduced an independent research governance quality framework for efficient review, compliance, and approval of all clinical research activity across the global network.

TENILLE BAKER Global Research Governance Manager

Tenille brings over 20 years’ experience in administration, clinical trials and research across both the public and private sector. She has previously held national research and business operational and research associate positions with a focus on trial compliance, standardised ethics procedures and audits, and quality trial tracking and archiving procedures. Tenille is a certified TransCelerate GCP trainer.

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ELIZA KEATING

Research Quality Specialist

Eliza started her career in academic research institutions with a strong interest in the field of oncology. She progressed to a Data Manager role before taking the position of Research Quality Specialist at Icon in July 2021. Her attention to detail, clinical experience and academic background reflects the skills required for maintaining regulatory standards and compliance for oncology and haematology clinical trials. Eliza leads evolutions for quality programs and systems across Icon Group to meet international expansion.

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HIGHLIGHTS

• Established a central feasibility assessment of clinical trials and overarching governance processes and Standard Operating Procedures to standardise research participation, safety, audits and quality assurance

• Renewed engagement of key clinical stakeholders to ensure Icon’s clinical trials program and culture aligns with the company’s strategic goals, expanding clinician support and ability to conduct trials

• Voluntarily participated in a TGA Good Clinical Practice (GCP) inspection demonstrating Icon’s commitment to quality assurance and elevating the Group’s reputation of conducting first-class clinical trials. Participation in this inspection came prior to the official rollout of the formal TGA program, set to begin in early 2022. TGA inspectors selected Icon as one of the few Australia test sites, which has allowed the team to benchmark current quality research systems and prepare for the mandatory GCP inspections • Increased uptake in GCP and regulatory compliance through in-house 'train the trainer' program and a brand new online GCP module, facilitated by Executive

Manager, Sophie Mepham. More than 100 team members were trained in GCP in 2021. Focus is now on engaging more clinicians and research teams to participate in 2022

• The research quality team have plans to grow the global quality program through the implementation of an electronic quality management system