Creating an industry-leading clinical operations risk management function

Current and evolving regulatory expectations, as well as the rising complexity of drug development and clinical trial design and conduct, require an increasingly client-centric and efficient risk management infrastructure. Tactical and strategic development of risk management capabilities can facilitate identification of potential risk factors in advance of trial execution and participation, improving the quality of study design and taking a preventative approach by mitigating potential risks upfront. The goal is to drive and oversee high-quality risk management cross functionally and throughout the entire life cycle of a clinical trial, involving identification, assessment and management of risk to ensure participants safety and data integrity, whilst improving efficiency and productivity.

The Risk Management group would provide support to clinical study teams to develop robust risk management plans and integrate a risk-based approach throughout the entire process from study concept onwards. As a key element of operational risk management activities across the organisation, proactive cross-functional partnership in risk management can drive improvement in the design, delivery and reporting of clinical trials.

There are multiple factors that may influence the success of a platform where several teams, departments and stakeholders collaborate for knowledge sharing, performing risk assessments and developing response strategies:

A key parameter to create, develop and sustain a collaborative risk management team, is to identify staff who utilise their communication skills to iinfluence and negotiate effectively, demonstrating a genuine passion for managing risk cross-functionally.

Adopting a ‘one team’ approach based on transparency and trust, sharing perspectives and jointly reviewing key performance indicators supports the development of a team that understands the challenges of shaping an innovative way of managing risk in clinical research. At the same time creating opportunities for ongoing personal, professional and team development, in a future focused environment.

Cross-functional risk management can significantly contribute towards improved decision-making, greater innovation and value creation. A survey conducted by ICON revealed clients were extremely satisfied with this approach in risk management operations, capability roll-out responses being very positive and encouraging. ICON cross-functional collaboration has helped clients in developing measures of success and showcasing the messaging around it. The formation of a new Clinical Risk Manager (CRM) role to support this platform continues to influence study teams to develop and improve their approach to risk management with an enhanced quality of protocols, reduced number of amendments, faster study start-up and higher quality trials. This approach has led to greater clarity within the study teams pertaining to risks associated with trials and improved guidance to manage these risks, resolving issues quickly and effectively while offering a shared platform for learning and working, both within and across programmes and study teams.