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FEATURED ARTICLES

  • The Direct-To-Patient Model: Your Top 10 Q&A

    In clinical trials, a direct-to-patient model allows for drug therapies to be delivered and administered in the patient’s home and/or biological samples to be taken and uplifted from the patient’s home. Depending on the complexity of the trial protocols, patients may take medicines themselves, or rely on a homecare nurse or caregiver for clinical support. Because the direct-to-patient model allows the patient to participate in the clinical trial from home, it reduces the need for them to travel to the investigator site, increasing the likelihood they will agree to participate and decreasing the possibility that they will drop out of the study.

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WHITE PAPERS & CASE STUDIES

  • Managing The Complexities Of Pharmaceutical And Life Science Logistics
    Managing The Complexities Of Pharmaceutical And Life Science Logistics

    Manufacturers and shippers of these products are under increasing pressure, as pharmaceutical and life science logistics becomes more complex and as the consideration towards better control of falsified medicines increases.

  • Countdown To The 2017 DSCSA Deadline: Serialization Strategies For Compliance
    Countdown To The 2017 DSCSA Deadline: Serialization Strategies For Compliance

    The next milestone for manufacturers, November 27, 2017, is the date by which pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.

  • Successfully Manage The Unique Demands Of Cell Therapy Supply Chains
    Successfully Manage The Unique Demands Of Cell Therapy Supply Chains

    Cell therapy professionals joined a specialist webinar by industry experts from PCI Clinical Services and TrakCel, addressing the unique complexity of an autologous therapy supply chain. Hosted by European Pharmaceutical Manufacturer magazine, the webinar was delivered by Rachel Griffiths, Associate Director, Technical Services, PCI Clinincal Services, and Dr. Matthew Lakelin, Vice President, Scientific Affairs and Business Development, TrakCel . Here, we present the white paper from that webinar event.

  • Complex Chain, Smart Security: How to Protect the Global Pharmaceutical Supply Chain
    Complex Chain, Smart Security: How to Protect the Global Pharmaceutical Supply Chain

    Your security strategy isn’t simple anymore, but that doesn’t mean it can’t be smart. As the industry has grown and changed, the pharmaceutical supply chain has become more global, introducing new vulnerabilities at each and every stage.

  • The Challenges to Safeguarding the Pharmaceutical Supply Chain
    The Challenges to Safeguarding the Pharmaceutical Supply Chain

    The loss of ingredients could trigger regulatory or legal liability, negative news coverage and a backlash from consumers criticizing your brand on social media. This is just one example of a potential risk your company’s global supply chain faces.

  • The Standards Myth: Why Your Temperature Controlled Packaging Is Failing And What To Do About It
    The Standards Myth: Why Your Temperature Controlled Packaging Is Failing And What To Do About It

    Global regulatory authorities are placing increased scrutiny on documenting control over distribution environments. While there is obviously a link between your shipping conditions and your thermal protection (packages), the challenge is that there is no clear, reliable industry standard temperature profile for the design of insulated packaging systems used for the distribution of products. This is because temperature profiles for packaging design should be rationalized based on not only your product characteristics, but your distribution logistics. This paper examines the lack of consistency in the current methodology for designing temperature profiles, why commonly used standards should not be used on their own, and identifies the needed parameters for consideration.

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PRODUCTS & SERVICES

EPS/EPP Foam Containers For Temperature Sensitive Shipments EPS/EPP Foam Containers For Temperature Sensitive Shipments

Summary: TempTrust™ can be purchased as a complete, qualified solution or as separate components.

Refrigerated Shippers - Pre-Qualified 2°C To 8°C Protection Refrigerated Shippers - Pre-Qualified 2°C To 8°C Protection

KoolTemp® Refrigerated Solutions are a complete line of tested and qualified small parcel-to-pallet size cold chain shippers for refrigerated applications.

Qualified Phase Change Materials (PCMs) Cold Chain Management Qualified Phase Change Materials (PCMs) Cold Chain Management

Temperature consistency when a PCM oscillates between solid and liquid phases is where a truly good PCM comes in handy. It matches the temperature of the product while it is going through its phase change, making it ideal for temperature sensitive applications.

Pre-Qualified Frozen Transportation Solutions Pre-Qualified Frozen Transportation Solutions

KoolTemp® STS (Seasonal Transport Systems) frozen solutions are a full line of qualified dry ice and suppressed temperature (non dry ice) shippers. Featuring multiple sizes and selective shipping time capacities designed for your frozen shipment needs.

TempTrust™ 48 Hours Of Cold Chain Packaging TempTrust™ 48 Hours Of Cold Chain Packaging

Typical regulatory standards are adequate for setting a baseline package design. However, repeated studies show that without applying the knowledge of climatic conditions in the areas which products are shipped and stored, companies are missing a crucial element to designing qualification of packaging methods.

KoolTemp® Room Temperature Solutions KoolTemp® Room Temperature Solutions

KoolTemp® Room Temperature Solutions are the industry’s most complete line of room temperature systems. Featuring multiple sizes and selective shipping time capacities designed for your room temperature shipment needs.

Cold Chain Cloud Database: liberoMANAGER Cold Chain Cloud Database: liberoMANAGER

liberoMANAGER is ELPRO's cold chain database built as cloud solution that centrally collects, verifies, automatically processes, and archives LIBERO PDF reports from cold chain shipments or site monitoring applications and is accessible from any location via web browser. liberoMANAGER is offered as «Software as a Service» and is operated, maintained, and updated by ELPRO. The solution is operated on a highly reliable and high-security data center (certified ISO 27001).

Central Monitoring System: elproMONITOR Central Monitoring System: elproMONITOR

Advanced Central Monitoring Software with the Most User-Friendly Alarming and Reporting Functionality
Managing an extensive network of laboratories, storage, production facilities or other assets is not an easy task. Being able to see the status of your facilities remotely from anywhere, at any time, becomes a «must have» requirement of our environmental monitoring system. The elproMONITOR software gives you this capability and provides you with total visibility.

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LIFE SCIENCE WEBINARS

  • Modeling Time-Dependent Processes More Accurately To Improve Quality And Control

    Batch processes are common in pharmaceutical, biopharmaceutical, food, beverage and chemical industries. When building models across various batches one may often encounter varying batch lengths and the batches may start from various relative points of time in a chemical context. Batch Modeling is important for process development and understanding the process for batch similarity and why some batches give a product quality outside the specifications.

  • Integrating Safety And Immunogenicity Assessments Into The Biopharma Preclinical Development Process

    Efficacy, safety, immunogenicity and manufacturability issues play a large role in the high attrition rate of biopharmaceutical candidates each year. To help reduce the risk of failure, tools to address the developability of preclinical candidates have been established.

  • The Implications Of Inaccurate Forecasting In Biologic Drug Substance Manufacturing And Strategies To Mitigate Risks
    The Implications Of Inaccurate Forecasting In Biologic Drug Substance Manufacturing And Strategies To Mitigate Risks

    The biopharmaceutical market is undergoing tremendous transformation. Speed to develop and manufacture product has become a critical driver with increased competition and the pressure to be first to market. New process technologies, advances in cell line development and more targeted and complex therapeutic classes have created a challenging biopharmaceutical manufacturing environment with new capacity requirements.

  • Assumption-Free Modeling Of Time-Dependent Processes

    Join this webinar to learn more about this unique approach and how you can benefit from it in different situations. Our Chief Scientific Officer will share the theory and background behind the solution and demonstrate how Unscrambler® X Batch Modeling from CAMO can improve the way we manage time-dependent processes and as an effect, get better quality control, detect events early and overall help improve quality of products and processes.
     

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