Compliance

PRODUCTS

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    cGMP Cell Manufacturing

    Are you in need of an experienced and flexible GMP service provider that can assist you with the development and clinical manufacturing of your gene or cell therapy with expert CMC support?

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    Biostatistics: End-To-End Management

    Discover how a team of biostatistics and pharmacokinetics experts can offer specialized guidance for clinical trial design and analysis.

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    Electronic Data Capture (EDC) System: Leverage Flexibility And Speed

    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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    Process Analytical Technology For In-line Bioprocess Analysis

    This easy-to-use process analytical technology device offers in-line bioprocess analysis and control with no complex modeling. Measure multiple critical parameters across media, across processes, across mammalian cell lines, across scales.

    All In-line Gain, No Modeling Pain

    MAVERICK is powered by Raman spectroscopy and a purpose-built de novo model. The de novo model is explicitly built on media chemistries and device physics, not on empirical data. It automatically interprets the spectra and quantifies process parameters enabling simultaneous measurements of glucose, lactate, and total biomass. This is achieved without the costs, complexities, and risks associated with conventional Process Analytical Technology (PAT) methods. There is no need to grapple with complex empirical models, reagents, or unreliable auto-sampling systems to implement in-line bioprocess analysis.

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    Lab Equipment Monitoring For The Modern Lab

    Ensuring the integrity of results and maintaining regulatory compliance are paramount concerns for any lab today, especially with increasingly complex laboratory processes. Cloud-based device management offers several advantages for laboratory equipment monitoring.

WHITE PAPERS AND CASE STUDIES

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    Virtual Study Yields High Compliance & Retention Rates

    Clinical research studies involving repeated patient reported outcome measures (PROs) face several challenges. Patients may fail to complete individual PROs, whether at all or within a specified time (i.e., reduced compliance). Patients may cease participating in a study altogether, dropping out before all study procedures are completed (i.e., reduced retention). Read how an app was used in a study that enrolled 124 patients resulted in the majority of participants in the study being 100% compliant and retained through study end.

  • Solutions To Global Pharmaceutical Supply Chain Challenges

    The global pharmaceutical sector is embarking on a transformational journey in which the supply chain will play an increasing strategic role. There will be a need for greater agility and speed to market.

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    Leveraging AI For TMF Classification To Improve Quality, Consistency

    Explore diverse AI methodologies, such as natural language processing and machine learning, elucidating how they seamlessly integrate with current systems to elevate efficiency and uphold quality standards.

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    Making Money With Security Awareness Training

    How addressing human error reduces risk and bolsters your profitability.

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    Validation Provider Shortens The Path To Equipment Qualification

    Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

  • A Bear-able E-Commerce Solution The Boyds Collection, Ltd. adopts a new Y2K-compliant e-commerce solution that provides its wholesalers with required bar code labels and advance ship notices. Chances are you’ve seen them, the porcelain and plush “Boyds” bears sold in department stores and on QVC, the cable home-shopping channel. The Boyds Collection, Ltd. (Gettysburg, PA)
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    Successfully Delivering Critical Stem Cell Samples Across The Globe

    To deliver multi-leg shipments of crucial stem cell samples on-time and within specifications, samples had to be collected from Japanese apheresis treatment centers and transported to a USA manufacturing plant within 24 hours.

  • Protect Your Health Records And Meet Your Compliance Obligations White Paper: HIPAA And Assureon
  • Sporting Goods Retailer Takes Safety And Product Testing To A New Level

    This U.S.-based retailer is an omni-channel sporting goods powerhouse offering a broad assortment of top-brand sporting goods equipment, apparel and footwear. They operate 645 locations with a blend of dedicated associates, in-store services and unique specialty shop-in-shops. As a producer of reliable, high-quality products that their loyal customers have come to expect, product safety and compliance are major focuses for this sporting goods retailer.

  • USP Acceptable TOC Levels For Pharmaceutical Water: How To Achieve Them? Meeting the regulations and validation rules is an important task for the pharmaceutical industry. In order to be compliant with the regulations and meet the required quality and safety standards, the Pharmaceutical industry must develop economical and competitive production and cleaning methods, which in turn will help the industry develop appropriate operational methods. Submitted by Shimadzu Scientific Instruments
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    Accelerating Results For Healthcare Brands Through Advocacy, Materials Science Expertise And Integrated Packaging Capabilities

    Any change to packaging design for an approved pharmaceutical product is a time consuming, detail-orientated effort, even with small brand-driven changes––so when governments update packaging regulations on a larger scale, a company’s entire product line could be impacted, creating change management projects for sometimes hundreds of items. When Health Canada introduced amendments to the existing Food and Drug Regulations for non-prescription, over-the-counter (OTC) drug products in 2014, pharmaceutical organizations selling products in the Canadian marketplace knew they had a significant challenge to overcome

  • Protecting Cardholder Data In The Enterprise Retail Market Merchants are feeling increased pressure from credit card companies to comply with security regulations such as the Payment Card Industry (PCI) Data Security Standard (DSS) and Payment Applications Best Practices (PABP) and are being offered incentives to comply or facing harsh penalties for not complying. Submitted by IP Commerce

NEWS