Clinical Trials Products and Services
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Collect RWE With Natural History Studies
9/20/2023
Developing a therapy for a rare or ultra-rare disease is life-changing work with unique challenges. Examine how natural history data is being used to inform the clinical development process.
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Quality Assurance And Regulatory Services
6/23/2022
Robust quality and regulatory support protects our clients and ultimately patients.
Focus on compliance and continuous improvement
At the Center for Breakthrough Medicines, our quality management systems and regulatory services provide the highest level of compliance, control, and oversight for our client programs from the inception of the clinical trial through commercialization. Having a dedicated regulatory team on site supporting your program will allow for real-time process information and analytical data to be procured, evaluated, and applied to your submission filing. The requirements of an IND/BLA are complicated and can be difficult to interpret. By partnering with CBM, we can utilize our strong relationships with the health authorities and collaborate with you to make sure your filing meets the stringent requirements set forth by the agencies, minimizing any potential delays to your program resulting from the review process.
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Making The Impossible Possible In Oncology And Hematology Clinical Development
9/20/2023
When the complexities of designing and executing cancer trials in a highly competitive market can mean delays in delivering urgently needed treatments to patients, it pays to have a trusted partner by your side.
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Bringing Endocrine And Metabolic Disease Treatments To Market
9/20/2023
Metabolic and endocrine diseases are a rising therapy area focus for clinical research due to the high demand for novel therapies that are challenged with proving safety and efficacy.
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cGMP Manufacturing And Automation
8/16/2023
End-to-end solutions for cGMP manufacturing across the entire cell and gene therapy product lifecycle.
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TrialKit: Your Comprehensive Solution For Non-Interventional Studies
4/5/2024
Elevate Your Clinical Research Data Collection
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Driving Successful In CNS And Neurology Trials
9/20/2023
Second, only to Oncology, CNS, and Neurology clinical trials are incredibly complex and complicated to navigate.
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Cell Therapy CDMO Services
4/16/2023
Selecting a manufacturing partner who can manage all aspects of your product development lifecycle and associated supply chain is essential to improve efficiency and product quality.
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Preparing Regulatory Marketing Applications For Successful Conclusions
9/27/2023
Preparing regulatory marketing applications to their successful conclusions is our focus.
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TrialKit EDC
3/12/2024
Modern clinical trials require modern technology. Leverage the flexibility and speed of the cloud with TrialKit electronic data capture (EDC).