Technological Evolution in Clinical Data Management
Pharma Tech Outlook

A featured contribution from Leadership Perspectives: a curated forum reserved for leaders nominated by our subscribers and vetted by our Pharma Tech Outlook APAC Advisory Board.

Pacira BioSciences Inc

Technological Evolution in Clinical Data Management

Armand Matejunas is a distinguished R&D leader who possesses expertise in Clinical Data Management, Clinical Operations, Clinical Technologies, Vendor Alliance Relationship Management, and IT. He focuses on quality, delivery, and cost efficiency. Throughout his management career, he has collaborated internally and externally to ensure timely and budget-oriented delivery of clinical trial data.

Matejunas worked with service providers in a partnership model to drive cost savings via standardization and automation. As a strategic leader, he has established organizational and service provider models that best suit the company’s needs, including prioritization and execution.

Could you please provide insight into your roles, responsibilities, and day-to-day tasks in your organization?

Throughout my illustrious four-decade journey in the industry, I’ve traversed diverse roles, starting from the trenches of Fortran programming at Hoffman La Roche. Climbing the ladder, I’ve delved into realms of data management, operations, and leadership, crafting a path of expertise. Presently, I proudly helm the ship of clinical data operations at Pasiro Biosciences, a dynamic entity with a global workforce of 750. Despite our modest product portfolio, we orchestrate three to five studies annually, a testament to our impactful presence in the field.

At Pasiro Biosciences, my pivotal role revolves around erecting a robust data infrastructure, ensuring the seamless capture and purification of vital information. Collaboration with our esteemed CEO and CRO is integral as we navigate through a mosaic of third-party data sources, ranging from wearables to labs, meticulously stitching together the fabric of insight. Embracing industry standards fervently, we uphold a commitment to excellence, optimizing both quality and efficiency across our operations.

Over the past few years, how has the industry evolved and what challenges are leaders facing today with their roles and responsibilities?

The industry is confronted with myriad challenges, chief among them being the perception and practical utilization of AI. There’s a pervasive struggle to grasp its efficacy in data capture and document structuring. Additionally, a crisis of faith in the CRO sector looms large, evident in the trend of major corporations pulling operations in-house. Despite recognizing the importance of data and technology, there exists a glaring misalignment between aspirations and financial commitments. While companies vocalize the need for advanced capabilities, budget constraints often relegate these projects to the back burner.

“Without a resolute dedication of resources—be it financial backing or skilled personnel—desired outcomes will remain elusive”

However, the trailblazing entities poised to shape the next decade or two are doubling down on technology and datacentric strategies without compromising elsewhere. CEOs and heads of R&D face the formidable task of resource allocation, grappling with the dilemma of where to invest. Yet, the truth remains: cutting-edge technologies demand substantial investments, both monetarily and in human capital. Without a resolute dedication of resources—be it financial backing or skilled personnel—desired outcomes will remain elusive. In essence, achieving transformative goals necessitates backing aspirations with tangible resources.

How have you adjusted your leadership approach to address these challenges? What strategies have you employed?

In the realm of small companies, the uphill battle to advocate for investments in technologies facilitating cross-portfolio analysis and big data can be daunting. Convincing the heads of IT, R&D, and ultimately the CEO of the necessity of such investments poses a significant challenge. The prevailing focus often tilts towards resolving immediate, backward-looking issues—like retrieving protocols from years past—rather than contemplating future-oriented endeavors. Document management solutions might not even be part of the small company’s infrastructure, intensifying the imperative to address existing deficiencies rather than contemplating expansive growth prospects.

Consequently, breaking through the inertia to promote novel technologies within small companies becomes an arduous task. Prioritizing immediate needs over future potentials becomes the norm, creating a barrier to embracing transformative advancements.

In your opinion, where is this space heading? Any upcoming trends that could disrupt it?

Undoubtedly, AI stands as a prevailing trend, yet within midto-large companies, navigating internal political dynamics emerges as a paramount challenge. Securing alignment among key stakeholders—namely, the CEO, head of R&D, and head of IT—on the objectives and financing of AI initiatives becomes imperative. Without this synchronized harmony, the plethora of discussions and eloquent presentation decks may amount to mere spectacle devoid of tangible outcomes for the company.

In essence, fostering cohesion among leadership is not just about espousing the virtues of AI but rather about forging a unified vision and commitment to its implementation. Only through collective alignment can companies effectively harness the transformative potential of AI to drive meaningful progress and competitive advantage.

What advice would you give to your peers to navigate this changing space, especially when it comes to AI?

Absolutely, before diving into investments in emerging technologies like AI, it’s paramount to conduct thorough research and due diligence. Take the time to immerse yourself in the intricacies of the field, becoming fluent in the conversations surrounding it and grasping all relevant details. Resist the allure of flashy sales pitches and glossy magazine spreads; substance outweighs style when it comes to informed decision-making.

In our haste to accomplish tasks swiftly, it’s easy to overlook the importance of measured, deliberate progress. Embracing a “slow and steady” ethos often yields superior results, particularly in the realm of technology adoption. Rather than fixating on grandiose, long-term outcomes, focus on demonstrating early wins and achieving milestones incrementally. This iterative approach mirrors the ethos of app development, where progress is made in manageable increments.

By breaking down ambitious goals into digestible chunks and delivering new capabilities gradually, you can ensure a more realistic and achievable trajectory, particularly in the realm of disruptive technologies like AI. This pragmatic approach not only minimizes risk but also sets the stage for sustainable growth and innovation.

The articles from these contributors are based on their personal expertise and viewpoints, and do not necessarily reflect the opinions of their employers or affiliated organizations.