How can Quality and Operations Teams Work Collaboratively to Drive Value for Clinical Trial Sponsors?

The synergy between clinical trial quality and operations teams is vital for delivering value to sponsors. Effective collaboration between these teams can lead to smoother project execution and, ultimately, better outcomes for patients. However, achieving this level of coordination requires a deliberate and strategic approach grounded in transparency and mutual trust.

Clinical trial sponsors often face the challenge of managing complex projects with multiple stakeholders, each with their own priorities and workflows. Bridging the gap between clinical quality assurance and operational efficiency is essential to ensure that trials run seamlessly and meet regulatory standards. The partnership between these teams must be built on a foundation of open communication and shared goals.

Xtalks recently spoke with Alison O’Neill, Chief Operating Officer (COO) at YPrime, who shares insights into how fostering strong partnerships and transparent communication between these teams can significantly enhance the clinical trial process. With over 35 years of experience in patient-centric clinical trials, O’Neill’s perspectives shed light on the transformative impact of collaboration on clinical trial success.

O’Neill’s extensive career has been dedicated to optimizing clinical trial processes, ensuring that sponsors, sites and patients all benefit from efficient, high-quality services. As COO of YPrime, she oversees project management and various teams, emphasizing the importance of collaboration and transparency.

In this interview, O’Neill delves into how a partnership mindset between quality and operations can drive significant value for clinical trial sponsors, ultimately leading to smoother project deliveries and better patient outcomes.

The Foundation of a Strong Partnership

Alison O’Neill emphasizes that a robust partnership begins at the very start of the engagement between the technology provider and the sponsor. By ensuring that all relevant information is transparently shared from the outset, potential pitfalls can be avoided later in the process.

For sponsors, sharing comprehensive information about the clinical trial, including protocol details and regulatory statuses, is crucial. This transparency ensures that technology providers are well-informed, leading to a smoother project delivery with fewer surprises.

O’Neill elaborates, “The sponsor benefits from having a smooth delivery of the project without coming across items that could have been clarified earlier.” This seamless collaboration ensures that clinical trials proceed without unexpected disruptions, allowing sponsors to meet their goals efficiently.

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Practical Steps for Building Effective Relationships

Sponsors aiming to cultivate a culture of collaboration with their technology partners can take several practical steps. O’Neill breaks it down into two parts: the interaction between sponsors and service providers, and the internal collaboration within the organizations themselves.

Firstly, sponsors should prioritize giving as much information as possible to service providers, rather than only what they deem necessary. Additionally, O’Neill stresses the importance of the human element in partnerships. “Don’t forget the people part of the partnership,” she advises. Project managers, who interact regularly, play a vital role in making these partnerships work. Face-to-face meetings, even if virtual, with cameras on, can help build stronger connections and foster trust.

Within organizations, it’s essential that operations and quality teams maintain a collaborative relationship. O’Neill points out, “It’s not helpful for a service provider to have the opinion that operations and quality teams never talk to each other.” Building a culture of trust and collaboration should be driven from the top, ensuring that quality goals align with operational objectives.

Key Factors for Successful Collaboration

At the heart of successful, value-driven collaboration are the relationships between individuals. O’Neill highlights the importance of interpersonal interactions, stating, “The key factors come down to how your individuals interact with each other. Do they get on with each other?” A strong partnership is characterized by mutual respect and willingness to communicate openly.

She emphasizes that a healthy partnership is one where communication is proactive and transparent, reducing the likelihood of unwelcome surprises. “Having the confidence in the relationship to say, ‘Hey, just to let you know this happened at a site,’ even if it may not be an issue, is crucial,” O’Neill explains. This proactive communication helps mitigate potential problems and fosters a collaborative environment where issues can be addressed promptly and effectively.

The Role of Transparent Communication

Transparent communication is the cornerstone of building trust between technology providers and sponsors. “The more transparent the communication is, the easier it is to run a clinical trial and therefore benefit the clinical trial process,” O’Neill asserts. When information is readily available, all parties can plan and anticipate needs more effectively, leading to smoother interactions and better outcomes.

In the clinical trial landscape, where patients are awaiting new treatments, transparent communication ensures that the development process is efficient and reliable. As O’Neill concludes, “Trust and transparent communication are two different things, but they require each other to thrive.”

By prioritizing these elements, sponsors and technology providers can enhance their partnerships and deliver successful clinical trials that ultimately benefit patients and the healthcare industry as a whole.

This article was created in collaboration with the sponsoring company and the Xtalks editorial team.