Precision's President Sofia Baig on Change, Adaptation & The Future of Clinical Research from a CRO’s Perspective

The following is an interview of Sofia Baig, President of Clinical Solutions at Precision For Medicine.

How has your experience in the industry shaped your approach to leading the Clinical Solutions business unit at Precision for Medicine? 

Before arriving at Precision for Medicine, I spent the last 25 years with Parexel, leading multiple global functions within the clinical research division, overseeing some of the largest customer accounts, and driving significant operational and business changes across the organization. While I assumed a variety of roles at Parexel, the common theme was challenging the organization to evolve and embrace the next-generation solutions that better support our customers and growth ambitions.

When I look back at the last 30 years in this sector, a key lesson I have learned is that your success is highly dependent on having the right talent to help execute your strategy. There is nothing sophisticated or new about this concept, and yet it is the most challenging thing to achieve in a business environment, as it often requires courageous decisions around your talent. When you get the right people in the right places, create a collaborative team environment, and enable a high-performance culture and mindset, the sky is the limit in terms of what you can achieve.

In my experience, lacking the right people limits an organization's effectiveness, even with impeccable systems and processes. Conversely, you can have suboptimal systems and processes, but with the right people, you can still deliver outstanding results despite these limitations. The service organizations that consistently succeed and grow are the ones that differentiate themselves through their people.

Another key lesson I have applied is that organizations must be structured to embrace and adapt to continuous change, as it’s the only way to stay ahead of the ever-evolving market needs. When I joined Precision, what I loved was that the organization was already set up with this future-leaning mindset. It’s a tremendous competitive advantage.

What have been your key strategic initiatives since joining Precision for Medicine, and how are they influencing the company’s present and future success? 

My primary strategic initiatives have centered around optimizing our global business through people, process, technology, and culture. I’ve focused on breaking down silos, enhancing collaboration, and implementing new KPIs to boost organizational performance and drive growth. Our people remain at the core of our approach, ensuring we have the right individuals in the right positions to create a nimble, adaptable organization that can meet our clients’ needs in this ever-evolving landscape.

Additionally, I am passionate about promoting workplace diversity, especially gender diversity, at all levels of the organization. I actively champion and mentor employees on their leadership journey and have initiated company-wide conversations about gender diversity and unconscious bias.

By concentrating on these strategic initiatives, I am ensuring we keep a keen eye on delivery for our clients while continuing to grow a strong, diverse, and capable team that is performance oriented and adaptable to changes in the industry.

How is Precision for Medicine prioritizing the needs of your clients, and what steps are you taking to ensure that Precision for Medicine delivers exceptional service and results?

I strongly believe that the secret to running a successful CRO is to keep the customer at the heart of every thought and action. When our clients trust us with their trials, we must honor that trust by delivering for them. We must put ourselves in their shoes, prioritize their needs, and consider their unique perspectives [and objectives].

Recently, we introduced an innovative training program called Risk-Based Project Management, codeveloped with one of our valued clients. Their invaluable insights illuminated the expectations our clients have for project managers, as well as effective risk management and communication strategies. This unique training program equips our team with the skills needed to elevate our service delivery and surpass client expectations.

This customer-first mindset is weaving into the very fabric of our organizational culture. I am steadfast in ensuring that every aspect of our operations—and, most importantly, of our people—remains wholly focused on serving our clients and, ultimately, the patients who rely on the life-changing advancements we help bring to fruition.

Can you share some examples of how Precision for Medicine is leveraging data and technology to enhance the efficiency and effectiveness of clinical trials? 

I’m a firm believer in leveraging data effectively to improve study efficiency and effectiveness. We’ve developed a number of strategies to provide increased insights for clinical trial planning and execution.

For example, our external partnership strategy involves collaborating with partners with enriched data to identify and target the right patients and sites. Optimizing trials by selecting the right countries, sites and patients is crucial, as these factors directly impact study costs and timelines. Leveraging external datasets helps us better target and optimize site selection, ultimately benefiting our customers.

In addition, we focus on building teams and products that access, consolidate, and aggregate data for better insights and decision-making. For instance, our Data Sciences business unit, QuartzBio, offers virtual Sample Inventory Management and a Biomarker Data Management platform, linking clinical data to biomarker and pharmacokinetic data.

Another case in point, is our Clinical Science Analytics and Insights (CSAI) team, which supports cross-functional integrated data reviews, ensuring high-quality oncology data from both scientific and clinical perspectives.

By harnessing the power of data and technology in various ways, we’re able to enhance the efficiency and effectiveness of clinical trials, ultimately benefiting both our business and our clients.

Can you provide some insight into the role of patient centricity in the future of clinical research, and how is Precision for Medicine embracing this approach? 

Patient centricity is vital for the future of clinical research, and at Precision for Medicine, we lead with patient-centric solutions, particularly in rare disease studies. Our sponsors appreciate this approach, and we collaborate to offer patients concierge services for travel, lodging, meals, and reimbursements. We’ve also implemented in-home nursing, home IP shipments, and telehealth visits, with many of these strategies becoming more commonplace since the pandemic.

The indication being evaluated, protocol requirements, and the sponsor’s receptiveness to patient-centric solutions and associated costs will always dictate how far we can go as a CRO for any given study. However, we know it’s essential to make trials more accessible and convenient for both patients and sites. Engaging and working closely with our sponsors and advocacy groups for a given population help us gather invaluable insights and field solutions that help our patients and their caregivers, especially in rare disease trials.

In summary, we emphasize patient-centricity in clinical research wherever possible. As an industry, we need to continue our work on adapting and evolving to make trials more accessible, diverse, and accommodating to patients’ needs, and by doing so, this will ultimately benefit all parties involved.

How does Precision for Medicine stand out in a competitive marketplace, and what unique value do you offer to your clients? 

At Precision for Medicine, our name truly embodies our unwavering commitment to advancing the frontier of precision medicine. This dedication places us at the forefront of groundbreaking research, and it’s a passion that permeates our entire organization. We’ve built our foundation with the future in mind, giving us a strategic edge over larger and similar-sized competitors.

Our agility and adaptability empower us to evolve swiftly alongside the ever-advancing field of clinical research. This flexibility enables us to stay ahead of the curve, consistently delivering innovative solutions that resonate with our clients. Moreover, our comprehensive suite of services seamlessly integrates global CRO capabilities with state-of-the-art specialty and central labs, sophisticated biomarker data management, and invaluable insights. This unique fusion of expertise sets Precision apart, offering unparalleled value to our clients.

We have emerged as a partner of choice for pharmaceutical and biotech executives seeking to revolutionize the future of medicine. I think that when we work together, we can make a lasting impact on the lives of patients worldwide. That, at the end of the day, is what it is really all about. 

As the industry evolves, what do you see as the most significant trends and opportunities in clinical research and drug development over the next 5 to 10 years? 

In the ever-evolving world of clinical research and drug development, I truly believe that our current industry model is unsustainable, and it’s time for a major shift. While we’ve transitioned from large trials to smaller, targeted ones, the core issues persist. From my personal perspective, the crux of the matter lies in the fact that improvements have been made for clients and service providers but not for the sites and investigators themselves. The rapid introduction of new technologies and processes has inadvertently further burdened the investigators and clinical research coordinators we are so reliant upon as partners in the clinical research we conduct. This really needs to change.

The investigators and popular academic research sites leveraged today face significant challenges, such as retaining staff, providing quality patient care, and meeting the increased demands of clinical research. The multitude of technologies deployed by various companies has only exacerbated the situation. Each sponsor/CRO and their clinical trial requires site training for their unique technologies, placing immense burden and pressure on sites. It’s becoming increasingly apparent that we’re approaching the limits of what they can handle.

The common delays seen in startup and the overuse of academic research centers are all clear indicators that the site model must evolve to create a sustainable future for the industry. One enhancement to the current approach is to leverage community sites/networks where possible. This will not only improve the diversity of patients in clinical trials but also diversify site concentration and help spread the clinical research burden across a broader pool of sites.   While this will not solve the technology burden for the site, it at least starts addressing some of the existing challenges.

About Sofia Baig, President, Clinical Solutions at Precision for Medicine:

Strategic industry leader, adept at driving organizational change and delivering top- and bottom-line business growth. Expert in customer account management, global clinical development operations, and delivering transformational change. Winner of multiple prestigious awards, including the 2021 PharmaVoice 100 award, presented to the most inspiring leaders in the life sciences industry, and as part of a team who earned the 2022 Catalyst Award for DEI work.

About Precision for Medicine:

Precision for Medicine is the first biomarker-driven clinical research services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. The Clinical Solutions business unit provides full-service clinical trial management and execution services for Phases I-IV while specializing in Oncology, Rare Diseases, CNS, and Autoimmune. Precision for Medicine is part of Precision Medicine Group, with 3200 people in 40 locations in North America, Europe, and Asia Pacific.