Die vergangenen 5 Jahre
Wir sind stolzer CRO-Partner unserer Kunden aus den Bereichen Biotechnologie und Pharmazie und unterstützen deren Entwicklung von Medikamenten.
Zell- und Gentherapien
Your partner in developing cell, gene and other advanced therapies
Access multi-disciplinary, multi-modality experience to support your unique studies.
Get a patient-centric approach to optimize the development of your product.
Rely on our team to navigate complex logistics and implement practical solutions.
Bei der Auswahl eines Partners ist die Erfahrung von entscheidender Bedeutung.
156
Advanced therapy studies
1.665
Standorte
17.082
Patienten
Our top therapeutic areas for cell and gene therapies include:
Get the latest cell and gene therapy updates.
Wir stellen Ihnen die aktuellsten News, Events und Publikationen zur Verfügung.
On-Demand Webinar
Updates in Cell and Gene Therapy: Current Trends and Operational Considerations (61 Minutes)
White Paper
Fortrea's cell and gene therapy operational solution
White Paper
De-risking the patient journey in cell therapies: six key considerations
Artikel
Verschieben der Grenzen von Zell- und Gentherapien Informationsblatt
Clinical development solutions for cell and gene therapy.
We’re here to seamlessly deliver your next cell or gene therapy trial.
Wir erweitern Ihr Team und bieten Ihnen:
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Experience with multiple modalities
- CAR-T and AAV
- Other viral and non-viral delivery systems (e.g., adenovirus, LNP)
- Cell therapies (immune cell/stem cell, autologous/allogeneic, modified/non-modified)
- Gene editing (e.g., CRISPR, meganucleases)
- Advanced and complex therapeutics such as RNA-based therapies (e.g., ASOs, siRNAs), T-cell engagers and genetically modified organisms
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Scientific and medical expertise
Not only do we know how to work with these complex entities and recognize real or potential impacts on patient well-being, but we also understand the science behind how they work. We understand how these treatments are developed and manufactured, and how these complex characteristics impact the conduct of a clinical trial including:
- Protokollentwicklung
- Long-term follow-up (LTFU)
- Development of companion diagnostics
- Global regulatory requirements
- Vendor qualification
- Medical monitoring
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Global operational solutions
The complexity of these therapies can involve numerous operational challenges defined by the asset in development and reflected in the trial footprint. We offer best practices, solutions and technologies and operational flexibility to optimize the conduct of your clinical trial, including, but not limited to:
- Providing logistics support for autologous CAR-T cell therapies
- Navigating site selection, activation, and overall study setup
- Defining regulatory and GMO pathways timelines along with approvals
- Reducing the patient burden for LTFU studies
- Designing and implementing a program’s regulatory strategy, including early engagement (e.g., INTERACT, pre-IND), and when working with rare diseases and pediatrics
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Customized training
To ensure your team keeps up with complex and rapidly evolving technologies, we provide comprehensive custom training of all team members. Our Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT) and Oncology members provide targeted, study-specific training, as well as a formal Cell and Gene Therapy Training curriculum.
Ihre Anforderungen. Unsere Lösungen.
Als Anbieter eines umfassenden Managements klinischer Studien der Phasen I bis IV, klinischer Pharmakologie, von Lösungen für den Patientenzugang und anderer grundlegender Dienstleistungen arbeitet Fortrea mit aufstrebenden und großen Biopharma-, Medizintechnik- und Diagnostikunternehmen zur Förderung von Innovationen im Gesundheitswesen weltweit zusammen.
