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Discover the power of predictability with Fortrea for Biotech

We illuminate your journey of discovery with accountability, consistency and transparency. Committed to your mission TM

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Anticipating challenges to mitigate risk and guide key decisions

Our biotech solutions are designed to promote predictability as we anticipate potential challenges, navigate clinical trial complexity and evolve with your needs, supporting you every step of the way.

Empowering accountability for biotech success

We’re dedicated to owning your success, matching your urgency and determination at every step. We ask the right questions so we can design biotech solutions with precision and purpose. Our approach builds clarity into every stage of your clinical trial, propelling you to reach your next milestone faster.

Delivering consistency for a predictable path ahead

We scale and flex with you as your plans evolve so you can expect stability while maintaining critical momentum across all phases of biotech development.

We drive your progress with a biotech mindset

Reaching your next milestone and delivering your study within budget requires a proactive approach. Milestones matter, and you can’t afford to miss timelines. We empower our team through our Biotech Academy, providing a customer-centric perspective and the skillset to operate with agility, ownership and solution-focused thinking.

Building on our legacy forged from 30+ years of biotech-focused experience, we know how to enable accountability and transparency—helping you reach your next goal and owning your success at every step of the biotech journey.

Explore our Clinical Development Solutions
Biotech
Integrate regulatory, clinical, medical, market access and commercial strategies into your development

Integrate regulatory, clinical, medical, market access and commercial strategies into your development

Streamline processes and reduce costs with our dedicated product development team. We create holistic approaches that combine cross-functional knowledge across all phases of your development program as our consultants extend and enhance your team’s expertise. Discover how we foster seamless collaboration between our teams and yours to find the fastest path for product development.

Browse our Product Development Solutions

Access unmatched flexibility and scalability with Fortrea FSP (Functional Service Provider)

Our FSP delivery model provides continuity by seamlessly integrating scalable solutions across all phases of your study. Whether you need clinical operations, clinical data management, biostatistics and statistical programming or safety services and medical writing, our flexible, high-quality FSP collaborations are tailored to support the dynamic nature of biotech product development.

LEARN MORE ABOUT FORTREA FSP
Access unmatched flexibility and scalability with Fortrea FSP (Functional Service Provider)
Fortrea Intelligent Technology: Elevate productivity with actionable insights

Fortrea Intelligent Technology: Elevate productivity with actionable insights

Fortrea Intelligent TechnologyTM can transform clinical trial operations by integrating AI-powered, persona-driven solutions that help automate workflows, streamline oversight and elevate productivity— enabling sponsors, investigator sites and Fortrea project teams to deliver trials faster, with greater predictability, agility and quality.

Fortrea for Biotech: Experience that matters

In the last 5 years, we have supported:

80%+ of our customers are Biotech companies
2,700+ Studies
29K+ Sites
400K+ Patients

Everyone at Fortrea is extremely knowledgeable, approachable, and easy to work with. Fortrea is amazing at Clinical Pharmacology studies. This is the third study I have done with Fortrea and truly this is a place where Fortrea shines. Every project manager I have worked with has been amazing. They are always prepared, anticipate future needs, reply to emails quickly and prioritize tasks for the study.

Clinical Trial Manager Biotech

The core Fortrea team supporting the study is the driver of success. Great communication, proactivity, experience, relationship building, and investment in the sponsor/protocol are some of the many ways I would describe them. The core study team, including the PM, lead CRA, start-up lead, and CTL, are all experts in their roles.

Clinical Studies Manager Biotech

Perfect quality system and will give a Biotech company special care. The PM was helpful and special considerations were provided in the study budget.

Clinical Trial Manager Oncology, Biotech

I am very pleased with the Team members at Fortrea that I have interacted with and in particular with the Clin Ops Team. They've been maintaining timelines for critical deliverables such as interim clean data extracts and final database lock.

Clinical Project Manager Oncology, Biotech

Overall, I am extremely satisfied with Fortrea's service on our study and would highly recommend them. Within the last 6 months, Fortrea has successfully completed a number of regulatory submissions. Both submissions were completed in a timely manner. Within the last 6 months, Fortrea has successfully recruited the 6th patient for the study, reaching the 50% patients enrolled milestone. Fortrea is also very proactive when it comes to potential eligible patients for the study and proposing all possible solutions in order to enroll patients.

Clinical Project Manager Endocrinology, Biotech

This is my second hAME study with Fortrea and both have been very successful. Fortrea Clinical Pharmacology was excellent in working with us on the formulation aspects of the study. The site was also excellent in achieving their tasks on time.

Director, Clinical Operations Biotech

The project manager assigned to the study did an excellent job on managing the program. The project manager provided great oversight and support to ensure all deliverables were delivered on time and on budget. Also, he was flexible and managed any changes in scope effectively.

Clinical Trial Manager Biotech

Biotech Portfolio Leads: Driving success together

Our Biotech Portfolio Leads (BPLs) embody Fortrea’s commitment to serving our emerging and established biotech customers with agility, accountability and collaboration. As seasoned operational leaders and portfolio-level advocates, they help biotech customers receive the strategic alignment and solution-focused delivery they require for predictable results.

Our BPL team blends deep industry and operational expertise with a hands-on approach to guide portfolios from proposal through delivery, achieve meaningful outcomes and enhance the customer experience.

Biotech Portfolio Leads: Driving success together

Biotech Frequently Asked Questions

Driving innovation in biotech

  • What challenges do biotechs typically face?

    Four main challenges include high industry competitiveness, scientific and technical uncertainty, limited funding and financial risk and building and managing the right team.

  • How competitive is the biotech industry?

    Biotechs are racing to develop novel treatments using unproven science, facing rising development costs, crowded clinical trial markets and increasing pressure to produce meaningful data.

  • What risks do biotechs face in early stage development?

    Early stage compounds often target areas with little existing data. A failed compound can be devastating since many emerging biotechs only have one or two assets in the pipeline. Missteps in site selection or trial execution can result in delays and financial setbacks.

  • How can biotechs address funding concerns?

    Biotech products can take years to reach the market. This requires multiple funding rounds, each tied to development milestones. Biotechs need to meet their milestones to build investor trust and secure future funding.

  • How important is biotech project management?

    Biotechs often have small teams and each individual plays a significant role. Leadership must maintain investor relationships and build a cohesive team aligned with strategic goals. They also need to decide what work stays in-house and what is outsourced to a CRO to extend the team’s expertise.

  • What’s the key to building an effective biotech development strategy?

    Biotechs must plan early and align all activities with a defined end goal, such as regulatory approval or a key fundraising round. It’s essential to understand potential risks, consider all data requirements and develop a disciplined execution plan.

  • How are biotech clinical trials support through protocol design?

    Biotechs should ensure their protocols are scientifically focused, operationally feasible, patient-centric and supported by appropriate data. It’s important to discuss development plans with regulatory authorities early, especially for advanced therapies, and consult subject matter experts to avoid costly missteps and align with evolving regulations.

  • How can working with a CRO (Contract Research Organization) enhance biotech solutions?

    Biotech CROs bring scientific and regulatory experience, promote operational efficiencies, leverage global site and KOL (Key Opinion Leader) networks and develop strategic approaches in trial design and execution. They support biotech research and development, managing the complexities of drug development while allowing the biotech to focus on their core business and fundraising.

  • What is the outlook for biotech innovation?

    Despite high risks and costs, biotechs are increasingly capable of taking drugs from discovery through commercialization—especially with strong strategic planning and the right support.