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“Customers will never love a company until the employees love it first.” Simon Sinek

The experience of culture

Company culture plays a critical part in business success.  In our world of clinical research, where outsourcing is a fact of life, and different organisations need to come together in positive collaborations, cultural issues can make the difference between success and failure for a project.  But what is company culture, and importantly what does a positive culture look like for an organisation’s employees and its customers? To me, company culture represents a set of working beliefs set by a company’s leadership, but bought into, and owned by that company’s employees. At its most extreme, a poor culture can be seen in an unhappy, demoralised workforce – in such a situation, customers may experience the vendor’s culture in the form of lack of accountability and poor quality deliverables.

On the other hand, in a business with excellent working culture, employees feel empowered to communicate openly with leadership, grow their careers, and think for themselves- this naturally impacts on the quality of service experienced by the company’s customers.  The hallmarks of a positive culture include a balance of management without micromanagement, learning and development focus, as well as community spirit and celebration in shared achievements.  In a motivating working environment, individuals tend to take great personal pride in their work. This pride and ownership is supported by a shared responsibility for the outcomes and investment in proper training, tools, systems and processes.

Aligning the perspectives of CRO and pharma stakeholders

Modern drug development depends on successful outsourcing and vendor collaborations. When building our vendor relationships, we should first acknowledge that sponsors and CROs are distinct types of organisations, with different motivations, organisational structures and measures of success. While a pharma company is measured on its ability to develop innovative products , within CROs, we are typically measured on our productivity and the quality of our deliverables.  Yet, despite these different perspectives, as team members within an outsourcing partnership we can all unite around the common goal of bringing effective new medicines to patients in as efficient a manner as possible. As a CRO leader I hope to positively impact the working culture by helping my team to develop a good understanding of the broader impact of their day-to-day work. CRO teams who genuinely get to grips with their customer’s therapy area, understand its unmet needs and appreciate the impact the new medicine could have on patients will derive greater meaning from their work, and contribute with a deeper purpose.

Establishing these shared goals and perspectives can be particularly crucial within an FSP outsourcing partnership.  In contrast to study-based outsourcing, FSP partnerships involve the CRO building teams of people to work on the sponsor’s projects or programs, using the sponsor’s systems and processes.  These kinds of outsourcing relationships are typically longer term than traditional study-based outsourcing and require a commensurately higher level of investment. In FSP outsourcing, the CRO and pharma functional leadership team, as well as the operational teams, work closely together.  As such, there needs to be an overlay in culture as well as a deep understanding of expectations. Shared pride in deliverables, close communication, and an environment that allows for questions to be asked, are essential components for cultures to align and a partnership to thrive.

Acknowledging culture at the vendor selection stage

Given the importance of culture in building a successful partnership, particularly for FSP relationships, a robust vendor selection process should take proper measures to assess fit.  In today’s procurement environment, vendor selection decisions typically rely on cost factors, the operational details of the proposal, and senior-level discussions between leadership teams during bid defense meetings.   However, in my experience, the ultimate success and overall cost-effectiveness of a project relies, to a great extent, on the members of the CRO’s proposed operational team, and how well they gel with their sponsor counterparts. So,why not take the opportunity, at the vendor selection stage, of bringing at least some of the operational team members together to ensure a match of values and communication styles?  By sitting down together and meeting face to face, we can all get a more genuine understanding of one another’s working style. 

The good, the bad, and the ugly of outsourcing relationships

In successful outsourcing partnerships where the cultural elements work well, the outcomes can be exceptionally positive for individuals as well as the organisation. In the course of my career in clinical research, one particular project stands out for me as an example of what strong partnership and cultural connection can achieve. This global partnership started modestly with our CRO working on a few study-based clinical analytics projects for a global sponsor. Over time, these small projects evolved into a full embedded FSP deal involving a large number of people.  As part of that agreement, the sponsor’s employees were eventually taken on by the CRO. We opened local offices for our new colleagues, and our two organisations’ cultures began to intertwine very closely. We even adopted some of the sponsor company’s traditions – like office ‘cook-outs’ into our own way of working! The way this partnership evolved was of course relatively unusual and reflected high levels of trust between us, as the CRO, and the sponsor. Deep trust comes with a partnership that has been well set up and well managed throughout. The cultures are in step, the budget’s right, there’s a mutual understanding of the objectives and timelines, along with secure communication and successful governance.

CRO employees working within a successful FSP project can benefit enormously by directly experiencing another company’s culture, products, systems, processes, and innovation.  Embedded within a sponsor’s team, they have the opportunity to be part of the evolution of a drug candidate. On the other side of the coin, through working with their CRO colleagues, the pharma team can be exposed to fresh, new ideas that can help to accelerate their own development and knowledge.

However, as we know, not all partnerships succeed.  Most of us working in the field have come across difficult situations where a project needed rescuing at the 11th hour- the sponsor thought activities were running smoothly, and in fact, they were not.  We typically find that these situations are caused by a combination of factors- including a lack of governance, poor oversight, or squeezed budgets. However, inadequate communication, lack of management of expectations, and an environment where questions and acknowledgement of mistakes are not encouraged are often co-contributors.

Building a positive culture

In practical terms, creating a positive culture for the benefit of employees and should be ingrained in all business practices .  With this motivation and focus in place, developing effective relationships with other organisations is a natural next step. Whether through formal measures like team training, or other informal means, deepening the team’s understanding of its contribution to the ‘greater good’ is a fundamental building block.  We can all strive to create an environment where good work is recognised, and individuals are empowered to rectify mistakes or improve processes for the future. But even with the best of intentions, issues and misunderstandings can occur in any organisation. Therefore continual monitoring is vital- having clear and accessible communication pathways that allow employees to raise concerns, and an open-minded leadership that is ready to act on suggestions will guard against issues and will enable the culture to evolve and continually improve.

Stuart McGuire

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