Fortrea Taps Legal Veteran to Navigate Growth in Complex Clinical Trial Landscape

NEW YORK, NY – November 17, 2025 – Fortrea Holdings Inc. has appointed Agnieszka (Aggie) M. Gallagher as its new General Counsel, a move signaling the company’s commitment to robust legal strategy as it expands its presence in the increasingly complex clinical development solutions market. Gallagher’s extensive experience in the life sciences and regulatory affairs comes at a crucial time, as contract research organizations (CROs) like Fortrea face heightened scrutiny and evolving regulations.

Scaling Operations Amid Regulatory Shifts

Gallagher brings over 25 years of experience to Fortrea, most recently serving as Chief Legal Officer and Corporate Secretary at Standard Biotools, Inc. Prior to that, she held key leadership positions at OraSure Technologies and Alnylam Pharmaceuticals, providing her with a deep understanding of the legal and compliance challenges facing the biopharmaceutical and diagnostics industries. This appointment follows the retirement of J. Stillman Hanson, who guided the company’s legal affairs during its transition to an independent, publicly traded entity following its spin-off from Labcorp in July 2023.

“The clinical research space is undergoing a period of rapid transformation, driven by technological advancements and evolving regulatory requirements,” explained one industry observer. “Companies like Fortrea need strong legal leadership to navigate these changes effectively and ensure they remain compliant.”

Fortrea’s growth trajectory, evidenced by its recent third-quarter earnings exceeding analyst expectations, necessitates a proactive legal strategy. The company, which provides services spanning all phases of clinical trials, faces increasing pressure to maintain data privacy, intellectual property protection, and adherence to complex international regulations. “The demand for experienced legal counsel with a strong understanding of both the scientific and regulatory landscapes is incredibly high right now,” the observer added.

Navigating a Competitive Landscape & Emerging Trends

The CRO market is intensely competitive, with established players like IQVIA, Parexel, and ICON plc vying for market share. Fortrea aims to differentiate itself through specialized solutions and agile service delivery. However, succeeding in this environment requires not only operational excellence but also a robust legal framework. “Companies need to be able to quickly adapt to changing regulations and protect their innovations,” noted an industry analyst. “A strong legal team is essential for managing risk and ensuring long-term sustainability.”

Several key legal and regulatory trends are reshaping the clinical research landscape. The implementation of the EU Clinical Trials Regulation (CTR) and the increasing emphasis on data privacy under regulations like GDPR and HIPAA are creating new challenges for CROs operating globally. Furthermore, the integration of artificial intelligence (AI) in drug development raises complex legal questions related to data security, algorithmic bias, and liability.

“The EU AI Act, in particular, will have a significant impact on clinical trials,” stated a legal expert specializing in pharmaceutical regulations. “Companies need to ensure that their AI systems are compliant with the Act’s requirements for risk management, transparency, and accountability.” Fortrea, like other CROs, must invest in robust data protection measures and develop clear policies for the ethical and responsible use of AI in clinical research.

Fortifying Legal Strategy for Future Growth

Gallagher’s appointment underscores Fortrea’s commitment to building a strong legal foundation for future growth. Her experience in navigating complex regulatory environments and managing legal risk will be invaluable as the company expands its global operations and pursues new business opportunities. “She’s a seasoned professional with a proven track record of success,” commented a source familiar with Gallagher’s work. “She understands the challenges and opportunities facing the life sciences industry.”

The company’s recent financial performance demonstrates its potential for continued growth. However, maintaining this momentum requires a proactive legal strategy that anticipates and addresses emerging risks. Gallagher will be responsible for overseeing all legal matters, including contract negotiation, intellectual property protection, regulatory compliance, and litigation. She will also serve as corporate secretary and chief compliance officer, ensuring that the company adheres to the highest ethical and legal standards.

Fortrea's growing backlog of $7.571 billion as of September 30, 2024, along with its Q3 2025 revenue of $701.30 million, points to the importance of effectively scaling legal operations alongside business expansion. “The ability to navigate the legal complexities of clinical trials will be critical for maintaining client trust and securing future contracts,” the analyst concluded. The appointment of Gallagher signals that Fortrea is prepared to meet these challenges and capitalize on the opportunities that lie ahead.