This client had made the strategic decision to focus on internal development instead of outsourcing their studies.

ICON, the global leader in Functional Service Provision (FSP) had established a working relationship with a local biotech company in China as a provider of contract staff. For local biotech companies, there are usually three options to choose from:

• To outsource the trials completely
• Focus on hiring more resources through a vendor
• Use a FSP solution to relieve some management burden and provide scalability to meet demand

With the focus on internal development this client was facing two major challenges that they anticipated would put this strategy at risk if not addressed head-on:

1. The rapidly expanding study portfolio required an exponential increase in the number of Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs) where our client experienced difficulties hiring due to the intense competition for talent in the Chinese market.
2. They found their increasingly limited internal capacity to manage, hire and train their resources, within tight timeframes demanded by the business, was becoming a major risk to meeting study milestones and quality. Adopting a FSP partnership allowed the company to continue to have full control over the clinical trial operations and retain their internal development strategy while insourcing an FSP team that was fully trained and supported by ICON.

Our comprehensive strategy focused not only on the management and sourcing of resources but on assuring the high-quality delivery of the trials. ICON University, our in-house training platform and dedicated specialist team, provided the framework for coaching and workshops to ensure best practice through a sustainable train-the-trainer model. In addition, line managers accompanied CRAs on site visits for hands on training with a focus on cultivating site relationships.

Our team took ownership of this challenge and solved their resourcing issues while also relieving the team management burden and maintaining high levels of quality.

Beyond this, ICON expanded and evolved their services in tandem with client development needs to maintain a sustainable partnership for 6 years as sole FSP provider. The team grew from 1 to 130, with broad career development from CRAs expanding to CTA, Operations Manager (OM), Project Manager and Trainer.

ICON’s ‘Own It’ culture adopts a solution-orientated approach to build the ‘One Team’ concept with the client, proactively provide insights and co-develop the process/infrastructure to optimise operation team management flow and resolve the client’s challenges by utilising our FSP expertise.

In 2022, with the expansion of the client’s scale and further improvement of quality and company culture requirement, our goal was not just ensuring delivery with high quality, but also accommodating their need to help optimise management infrastructure with the purpose to build up a high performance 'One Team'.
 

To manage the challenges with effective resource management and innovatively establish an infrastructure to ensure their success, ICON’s involvement was upgraded to full FSP partner to co-develop the team.

1. Developing new methodology for right resourcing and deeper OM management

We work collaboratively with our client to identify key competencies of each role and design a value-based hiring criteria to make sure we hire the best candidate from the outset (Client-tailored talent pool). We also develop a FTE management tool to enhance resource productivity, realise dynamic allocation when facing changing situations and make FTE forecasting more accurate. Most importantly, we decrease ICON OM ratio to make sure OMs have more time to upskill team members and ensure high-quality delivery in site management.

2. Optimising processes and system to increase efficiency of team working and KPIs oversight

We created a ‘one stop’ platform with a dedicated roadmap for each role enabling centralised up-to-date management leading to a more streamlined process. We also implemented a unified data analysis platform enabling effective KPI oversight across all levels by working in tandem with our client. Meanwhile, through proactive communication with the Quality and Project Management team on oversight findings and routine L&L sharing, we enhanced OM ASV and SVR review quality which focused more on finding out the root cause of CRA’s performance issue and coaching CRAs to correctly use CAPA methodology in their daily work.

3. Delivering and maintaining a high- performance team with a culture based on ‘accountability’ and ‘people focus’

We set a “tailored training working group” and implemented a ‘train to trainer’ dedicated to the program to make customised training courses with support from ICON’s extensive training resources and experiences to meet team actual needs. The training focus pivoted from traditional training to result-driven evaluation to identify knowledge gaps and build a proactive learning mindset in the whole team.

To better integrate our ‘People Focus’, we made clear career development ladder for different roles, developed related training programmes (CRA to PM, CRA to OM, CTA to CRA), regularly perform talent reviews and make specific IDP for notable talent, including special awards for high- level performance.

Our solution-oriented approach and comprehensive strategy enabled us to have a sustainable resource supply and maintain high standard team management and performance.

We delivered the following milestones despite the significant challenges of the COVID-19 pandemic in 2022:

Our initiatives on people development and engagement helped us to achieve a team retention rate of 85%, 13% higher than the average in China; around 25% staff gained personal development, incl. promotion and/or role transition.

Crucially, these methods of infrastructure development led to further improvements in overall quality delivery.