Clinical Development Organizations Primary Success Factors

Executive leaders at pharma and biotech companies are realising that an initial investment in a clinical trial associate’s (CTA) career can impact and build a resilient clinical trial management workforce in a world where organisational redesign and retooling are perpetual disruptions. More than 75% of respondents in recent interviews and surveys with leading biotech and pharmaceutical executives acknowledged a heavy dependence on the CTA position in organisational redesign and resource allocation modelling—especially the centralization versus decentralisation of this function.

Is it time for a pivot to centralization?

More than 75% of the companies polled said their clinical development organisations (CDOs) were strongly matrixed, indicating a shift toward centralising the CTA role. Companies that are moving toward CTA centralization have discovered that their approach is aligned with business implications by taking the following points into account:

By continually focusing on critical, impactful activities, they were able to gain efficiencies. Separating additional, essential, and impactful actions required for enterprise critical studies or other study criteria was also taken into account. Low-value activities were eliminated by carefully categorising tasks to identify low-risk consequences if they were not completed. Organisational leaders confidently shifted low-value activities. Identified

technology solutions for connecting sponsors and locations throughout the clinical research ecosystem in a seamless manner. Staff were able to delegate administrative and non-mission-important functions to other colleagues using these solutions.

Management of Change

Having a clear picture of the future state, as well as a sense of urgency and discontent with the existing quo, can help one avoid losing key personnel and causing substantial interruptions in the clinical trial efforts.

Methodology for Allocating Resources

Clinical trials make use of a variety of resourcing methods. The various tactics used by the top 10 life sciences businesses usually comprise one or a combination of the following:

• Outsourcing the full trial implementation to a contractual research organisation (CRO) is referred to as contract research outsourcing.
• Functional service provider (FSP) – By utilising a Functional Service Provider, one can save time and money.

• Hybrid- Either resourcing internally or via a hybrid methodology (e.g., internal and FSP)

According to industry benchmarking, larger, less matrixed organisations were split between CRO and FSP models, whereas small, less matrixed companies were divided between CRO and FSP models.

Resource Management Improves Efficiency

When deciding whether CTA centralization is the correct solution for the clinical development organisation, two crucial resource management considerations to consider are predictability and flexibility. The ability of people managers to actively promote talent development is a fundamental benefit of CTA centralization. While the CTA’s interaction with the clinical trial manager (CTM) is crucial, the CTM has a dual obligation to the clinical study as the trial leader and to the CTA as their personnel manager in a decentralised strategy. Several companies reported inconsistencies in CTM delegation to the CTA, with many just assigning administrative tasks.

Summary of Findings from a Centralized Clinical Trial Management Approach

Motivation: Approximately 90% of interviewees stated that the primary motivation for organisational redesign was to improve functional loyalty and increase company productivity.

Training: According to more than 80% of those polled, proper training and task delegation are essential for effective interactions between CTMs and CTAs. CTAs in matrixed companies who learned how to run clinical trials instead of how to do administrative tasks were more likely to stay at their jobs.

Continuous Assessment: It was critical to regularly review the right amount of work required to manage a centralised group in order to create efficiencies while growing talent.

Matrixed Organizational Structures: Depending on the complexity of organisational structures, one manager for 10–15 colleagues may be insufficient.

Turnover: The average turnover rate among the organisations examined was between 5% and 20%. These rates were greater for companies that used an FSP approach.