Explore how a U.S.-based biotech company leveraged CRO services through TFS HealthScience to manage a challenging CAR T-cell therapy study aimed at preventing life-threatening side effects in lymphoma patients undergoing immunotherapy. Utilizing expert project management, tailored solutions, and flexibility, TFS ensured operational success and addressed critical issues such as site engagement, drug supply shortages, and trial readiness.

What You’ll Learn:

• Innovative site engagement solutions to ensure efficient patient recruitment
• Proactive risk mitigation to address potential standard-of-care drug supply shortages ahead of time
• Customized training and support to prepare the Sponsor’s team for complex trial procedures
• Flexible and responsive CRO partnership for optimal clinical outcomes

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TFS Oncology & Hematology

Discover how a U.S. biotech company partnered with a specialized CRO to manage a Phase I oncology trial for a new treatment targeting advanced epithelial tumors. The collaboration covered regulatory consulting, site identification, clinical monitoring, and other services to optimize dose escalation and expansion phases. The CRO’s expertise streamlined operations, ensuring efficiency and adherence to regulatory standards.

What You’ll Learn:

• How a specialized study team handles seamless trial execution & complex procedures effectively
• The importance of proactive site selection, including a backup site, for enrollment speed & risk reduction
• How prompt data reviews & safety updates allow for timely recruitment & study completion
• The impact of skillful management on slot allocation, patient tracking, & data cleaning

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TFS Oncology & Hematology

A leading France-based gene therapy organization partnered with TFS HealthScience, a leading, global, full-service contract research organization (CRO), to navigate the complexities of conducting clinical trials for Duchenne Muscular Dystrophy (DMD) gene therapy. The collaboration successfully addressed challenges related to site selection, patient recruitment, and regulatory compliance, leading to significant progress in the trials. This case study details the strategic approach taken by TFS to ensure the trials met their goals, ultimately advancing research in a critical area of unmet medical need.

What You’ll Learn:

• The unique challenges of conducting DMD gene therapy trials
• How TFS effectively managed site selection and patient recruitment
• Strategies for navigating complex regulatory requirements across different countries
• The impactful results achieved through the collaboration between the sponsor and TFS

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TFS Neuroscience

A European biotech company partnered with TFS to manage their early-phase oncology study targeting advanced and metastatic solid tumors. With TFS’s comprehensive CRO services, the study achieved high enrollment efficiency and smooth clinical management, setting a strong foundation for future phases.

What You’ll Learn:

• How TFS ensured high recruitment efficiency through strategic site selection and management
• The importance of flexible contracting and strategic regulatory approaches in early-phase clinical trials
• Key strategies used by TFS to maintain protocol adherence and data quality
• The impact of close collaboration with Principal Investigators on study outcomes

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TFS Oncology & Hematology

Discover how TFS successfully supported a European biotech company in launching a groundbreaking adoptive cell therapy study amidst the global disruptions caused by the COVID-19 pandemic. This case study provides an in-depth look at TFS’s strategic approach and solutions that led to a successful study start-up.

What You’ll Learn:

• How TFS overcame regulatory and logistical challenges
• Key strategies for managing ATMP studies during a crisis
• The critical role of communication and project management in clinical trials

Download the complete case study to explore the innovative strategies and expert insights that drove this remarkable achievement.

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TFS Oncology & Hematology

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Delve into how TFS leveraged vast US real-world data to secure EMA approval for an extended-release CNS drug, bypassing traditional costly trials.

Witness how our RWE team’s innovative design and AI-assisted analyses cut costs by 30 times and accelerated timelines, achieving non-inferiority and even superiority in key endpoints. Download now to uncover the RWE-driven breakthroughs that delivered this triumph.

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Discover how TFS harnessed the power of Real-World Evidence (RWE) to transform a high-stakes clinical trial into a groundbreaking respiratory treatment in newborns.

Discover the strategic pivot from a traditional RCT to a cost-effective RWE approach that navigated low enrollment, ethical hurdles, and regulatory challenges. Learn how our experts’ innovative solutions led to a successful study redesign, approved by the EMA, which is set to reshape newborn care. Download now to see how TFS is pioneering the future of pharmaceutical development with agility and insight.

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Embark on a journey with TFS as we bring agility, reliability, and effectiveness to a large pharmaceutical company’s clinical studies, propelling them toward unprecedented success.

Delve into the meticulous strategy that reshaped the landscape of pharmaceutical collaboration. From creating customized team structures and specialized SOPs to seamless handovers and in-depth training, TFS left no stone unturned in ensuring impeccable quality and safety. Download now to unveil the blueprint for achieving excellence with an FSP.

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Discover the innovative approach TFS took in navigating the challenges of home care nursing amidst the COVID-19 crisis. Faced with the task of studying the impact of plasma-derived immunoglobin in a safe, home-based environment, TFS not only rose to the challenge but revolutionized home healthcare solutions for their patients.

Dive deep into the meticulous strategy — from designing custom organigrams and drafting specialized SOPs to onboarding and training an efficient team, all while ensuring utmost safety and quality. Download this case study to uncover how TFS’s unwavering commitment to care played a pivotal role in unveiling significant COVID-19 insights.

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Learn about the tailored flexibility and quality focus TFS implemented in their approach to a Phase IIIb study focused on Plaque Psoriasis in Adolescents. The study presented unique challenges due to a difficult recruitment process, ongoing global safety concerns, and a fiercely competitive environment.

Download the case study to learn about the pivotal role played by TFS’ experience and staff expertise in providing a full-service business solution that efficiently managed the study and maintained high-quality standards.