In a world where organizational redesign and retooling is a constant disruption, executive leaders at pharma and biotech companies are discovering that early investment in a clinical trial associate’s (CTA) career can impact and shape a resilient clinical trial management workforce.
In recent interviews and surveys conducted with organizational leaders from top biotech and pharmaceutical companies, more than 75% of respondents indicated a strong reliance on the CTA role in organizational redesign and resource allocation modeling – specifically, centralization versus decentralization of this function.
Pivot to Centralization?
More than 75% of the companies surveyed who self-identified their clinical development organizations (CDOs) as heavily matrixed structures revealed a pivot to centralizing the CTA role.
Companies trending toward CTA centralization aligned their approach with business imperatives and found that they:
- Gained efficiencies by consistently focusing on important, impactful activities. There was also substantial consideration for differentiating additional, important, and impactful activities needed for enterprise critical studies or other study criteria.
- Eliminated low-value activities by carefully differentiating activities to determine low-risk outcomes when not performed. Organizational leaders confidently reallocated resources for low-value activities.
- Identified technology solutions designed to seamlessly connect sponsors and sites across the clinical research ecosystem. These solutions allowed staff to reassign administrative and non-mission critical activities to other colleagues.
Change Management
Having a clear vision of the future state alongside a sense of urgency and dissatisfaction with the status quo can mitigate the potential risk of losing valuable talent and triggering major disruptions to your clinical trial activities.
Resourcing Approach
- Contract research organization (CRO) - Outsourcing the entire trial execution to a contract research organization
- Functional service provider (FSP) - Leveraging a Functional Service Provider,
- Hybrid - Resourcing internally entirely or through a hybrid model (e.g., internal and FSP)
Industry benchmarking indicated resourcing approaches reflected a trend towards an internal/hybrid model, while smaller, less matrixed companies were split between CRO and FSP models.
Efficiency Through Resource Management
Predictability and flexibility are two key resource management aspects to consider when determining if CTA centralization is the right approach for your clinical development organization. A key benefit of CTA centralization is enabling people managers to directly support their talent development. While the CTA relationship with the clinical trial manager (CTM) is critical, the challenge in a decentralized approach is the CTM has a dual responsibility to the clinical trial as the trial leader and to the CTA as their people manager. Multiple companies noted inconsistent CTM delegation to the CTA, many of which only assigned administrative activities.
Summary Findings from a Centralized Approach to Clinical Trial Management
- Motivation: About 90% of interviewees indicated the driving force for organizational redesign was to specifically address functional loyalty and to increase enterprise productivity.
- Training: More than 80% of those surveyed found appropriate training and task delegation were keys to healthy relationships between CTMs and CTAs. A critical retention factor for CTAs in matrixed organizations was ensuring they received training on conducting clinical trials as opposed to focusing solely on administrative work.
- Continual assessment: To drive efficiencies while developing talent, it was imperative to continuously assess the appropriate amount of work needed to manage a centralized group. Matrixed organizational structures: one manager for 10-15 associates may be insufficient dependent on the complexity of organizational structures.
- Turnover: On average, turnover rates among companies surveyed ranged from >5% to >20%. For companies deploying an FSP approach, these rates were higher.
To learn more about successful strategies for clinical development planning, download the Advarra Trend Report: The Future of Clinical Staff Development Planning.