Mike Failly, Ph.D., Zanteris Founder and Clinical Operations Consultant: “Effective Clinical Project Management helps to identify and mitigate risks, address challenges promptly, and ensure that the trial is conducted ethically and safely.”

In an industry where efficiency and precision are paramount, Zanteris stands out by offering a fresh, tailored approach to Clinical Operations and Outsourcing services. Founded by Mike Failly, a seasoned expert in Clinical Operations and Project Management, Zanteris was established with a mission to support Clinical Research Organization (CRO), small and mid-sized biotech companies in the clinical research industry. By providing customized consulting services, the company helps clients optimize the implementation of clinical trials, whether
they are new or existing, refine operational processes, and enhance team development. Specializing in Clinical Project & Vendor Management consultancy for the Life Sciences sector, Zanteris offers a comprehensive suite of study management solutions covering programs and clinical trials from Phase I through Phase IIIb. With deep expertise in Clinical Operations, financial strategy, and leadership, the company collaborates with clients to maximize opportunities and navigate challenges within the complex clinical trials landscape.

Leveraging a robust network within the CRO and life sciences industries, Zanteris plays a crucial role in helping CROs, biotech firms, and pharmaceutical companies select the right clinical trial partners. By streamlining vendor selection, optimizing operational efficiencies, and reducing internal oversight burdens, Zanteris enables organizations to save time, cut costs, and improve overall performance. With a commitment to innovation and excellence, Zanteris continues to reshape the way clinical trials are managed, ensuring success for its clients in an ever-evolving industry.

In conversation with Mike Failly,  Ph.D., Founder and Clinical Operations Consultant of Zanteris

How does your extensive experience in Clinical Operations and Project Management shape the way Zanteris delivers its consulting services?

Zanteris leverages extensive experience in Clinical Operations and Project Management to
deliver its consulting services in a highly effective and tailored
manner. With over 15 years of experience in the Life Sciences industry and more than 10 years in Project Management positions, Zanteris brings a wealth of knowledge and expertise to the table. This experience allows Zanteris to partner with organizations to optimize the implementation of existing or new clinical trials or programs,
company processes, and team development.

Zanteris emphasizes leadership as a key factor for success. What leadership qualities do you think are essential for clinical project managers?

Zanteris emphasizes leadership as a key factor for success in clinical project management. Essential leadership qualities for clinical project managers include:

Effective Communication: Crucial for coordinating with stakeholders and resolving issues promptly.

Decision-Making Skills: Ability to make informed decisions quickly in high-pressure situations.

Problem-Solving Abilities: Identifying problems, developing solutions, and implementing them effectively.

Adaptability: Responding to changes and unexpected situations in a dynamic environment.

Team Leadership: Leading and motivating a team to achieve project goals.

Attention to Detail: Ensuring compliance with regulations and protocols.

Strategic Thinking: Planning for long-term success by setting goals and developing strategies.

Can you explain the role of Clinical Project Management in ensuring the success of Phase I-IIIb clinical research studies?

Clinical Project Management plays a crucial role in ensuring the success of clinical research studies. It involves overseeing the planning, execution, and completion of clinical trials, ensuring that they are conducted efficiently and in compliance with regulatory requirements. Clinical Project Managers are responsible for coordinating various aspects of the trial, including site selection, patient recruitment, data collection, and analysis. They also manage budgets, timelines, and resources to ensure that the trial progresses smoothly and meets its objectives.

Effective Clinical Project Management helps to identify and mitigate risks, address challenges promptly, and ensure that the trial is conducted ethically and safely. By providing leadership and guidance, Clinical Project Managers help to optimize the implementation of clinical trials, improve team collaboration, and enhance overall trial performance.

With advancements in digital health and AI, how do you see the future of clinical project management evolving, and how is Zanteris preparing for these changes?

The future of Clinical Project Management is set to evolve significantly with advancements in digital health and AI. These technologies are expected to enhance the efficiency, accuracy, and overall effectiveness of clinical trials. Digital health tools can streamline data collection, improve patient monitoring, and facilitate remote trials, making the process more efficient and accessible. AI can assist in data analysis, predictive modeling, and identifying potential issues before they become significant problems, thus improving the overall quality and speed of clinical trials. Another example is AI in Biostatistics & Statistical Programming: AI-driven tools are enhancing efficiency, decision-making, and data quality in biostatistics and programming. These tools are shaping data organization, analysis, and reporting in clinical research.

Zanteris is preparing for these changes by continuously enhancing its services and adapting to new technologies. The company is committed to staying at the forefront of these advancements, ensuring that its clients benefit from the latest innovations in digital health and AI. This includes offering comprehensive training and development programs designed to equip Clinical Project Managers with the skills needed to navigate the complexities of clinical trials and drive successful outcomes.

What training and development programs does Zanteris offer to enhance the leadership and efficiency of clinical project managers?

Zanteris offers a range of training and development programs designed to enhance the leadership and efficiency of Clinical Project Managers. These programs focus on key areas such as typical skillset like effective communication, decision-making skills, problem-solving abilities, adaptability, team leadership, attention to detail, and strategic thinking but also around emotional intelligence and Project Manager behavior. Training may cover the Clinical Project Manager as CEO of the Project, CRO/sponsor oversight, finance, leadership, Bid Defense Meetings etc.

By providing comprehensive training in these essential leadership qualities, Zanteris aims to equip Clinical Project Managers with the skills needed to navigate the complexities of clinical trials, dealing with multiple stakeholders but also cultures and drive successful outcomes for their project.

What does the future hold for your company and its customers? Are exciting things on the way?

The clinical trials landscape in 2025 is undergoing a transformation driven by innovation and technology. At the heart of this evolution is artificial intelligence, revolutionizing everything from trial design to patient recruitment—dramatically reducing both costs and timelines. Real-world evidence and patient-first strategies are also reshaping how trials are conducted, boosting participation and improving outcomes across the board.

Zanteris is proud to be leading this charge. We’re committed to empowering Clinical Project Managers through robust training and development programs tailored to the demands of today’s rapidly evolving research environment. Our mission is clear: to equip professionals with the tools and insights they need to manage complexity, enhance performance, and deliver success.

As we continue to #UnlockClinicalExcellence, Zanteris is positioning itself as the go-to partner for biotech companies navigating the CRO and life sciences ecosystem. With personalized consulting services and a deep understanding of the industry’s unique challenges, we’re redefining how clinical trial partnerships are formed.

The future is bright—and Zanteris is just getting started.

“With over 15 years of experience in the Life Sciences industry and more than 10 years in Project Management positions, Zanteris brings a wealth of knowledge and expertise to the table.”