Clinical Trials Products and Services
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NDA Submissions 505(b)(1) Or 505(b)(2)
6/3/2024
There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.
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Electronic Data Capture (EDC) System: Leverage Flexibility And Speed
8/11/2025
Neither traditional nor hybrid clinical trials can operate on rigid EDC systems.
They require flexible data collection systems that support protocol amendments without downtime and accept mobile data without hassle. As a cloud-native solution, TrialKit bends to accommodate mid-study changes. And as the first full-featured EDC platform available as a native mobile app, TrialKit flexes to meet the demands of traditional, hybrid/decentralized, and completely remote clinical trials.
Give your team the freedom to build, deploy, and manage their studies, their way—weeks faster than with rigid EDCs and for a fraction of the cost of the major players.
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USP<1062> Tablet Compression Characterization
7/29/2024
Natoli Scientific takes pride in its comprehensive USP<1062> Tablet Compression Characterization services, tailored to address the complexities of tableting in pharmaceutical manufacturing. Staying true to the parameters outlined in the United States Pharmacopeia (USP) Chapter 1062, our approach meticulously evaluates tablet compression behaviors. By thoroughly characterizing the compression profile, we can pinpoint the optimal compression force required to form a cohesive tablet without applying undue stress that could lead to capping — the separation of tablet tops during or after the compression phase.
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Integrated Drug Discovery
7/1/2023
Finding a partner with integrated services is crucial for accelerating timelines and accessing solutions with comprehensive expertise, all while removing risk from the drug product lifecycle.
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Streamline Electronic Data Capture With iMednet EDC
1/22/2025
At the core of our comprehensive eClinical platform, iMednet EDC is uniquely designed to help sponsors and CROs achieve their clinical research goals. Highly flexible, it enables you to build studies quickly, while easily adapting to complex protocols and mid-study changes with ease.
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European Regulatory Development
8/29/2024
Scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes.
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Autologous And Allogeneic Cell Therapy Manufacturing Services
1/31/2023
Our comprehensive package of both autologous and allogeneic cell therapy manufacturing services includes GMP production of cells from pre-clinical to commercial applications from a variety of starting materials. As an experienced cell therapy CDMO, we’re able to swiftly scale-up and support production from clinical to commercial manufacturing. Need help with the development of your cell therapy?
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R&D Technology
8/22/2024
Technology solutions for life sciences that get products to market quickly and efficiently.
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Immersive Corrosion Testing Of Metals And Alloys
6/18/2025
Immersion corrosion testing is a method used to determine the rate of corrosion of a test article, often a metal, in aqueous solution. Though this test can be used as an assessment tool for many applications, it is commonly used to evaluate the corrosivity of liquids.
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Home Trial Support
11/22/2024
By removing barriers, and bringing trials to patients where they live, we can expand the geographical reach of clinical research across the globe allowing more patients to participate. Our patient-centric delivery means we can create convenience and comfort working the schedule of the trial around the schedule of the patient and their family, not the other way around. This approach provides important access to medical care, enhances the inclusivity of clinical trials and advances drug development for all.