PHARMA LOGISTICS WHITE PAPERS & ARTICLES

  • How Hollister Selected An Automated Solution For Tracking Product Registration And CAPA Management

    In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.

  • 3 Reasons Life Science Is Turning To Passive For Cold Chain

    Experience has shown the transition from active shippers to passive shippers is mainly driven by three factors: cost-savings, availability, and ease of use.

  • A Cure For Pharmaceutical Supply Chain Complexity

    The complexity of drug product supply chains has increased in recent years thanks mainly to the development of more complex chemical molecules and reduced average production volumes.

  • The Cold Chain: Asking The Right Questions

    The concept of cold chain shipping is decades old, but it wasn’t until the last several years that industry has seen great advances in technology, processes and standards for moving temperature-sensitive products. By Joe Reedy

  • A Challenge For Supply Chain Performance Is The Complexity

    How good is your supply chain performance? Many suppliers perhaps believe theirs is pretty good; however, it seems each year when businesses are surveyed by the numerous supply chain consulting firms and trade magazines, visibility usually ranks at the top of the list as an area for improvement. Indeed, the typical supply chain has become much more complex over the years as manufacturing expands to Asia, South America, Africa, and so on.

  • The Case For The Use Of Point-Of-Care Testing In Pharmaceutical Clinical Trials Clinical trials that are designed to evaluate the efficacy of novel pharmaceuticals require a variety of diagnostic tests to be performed on all enrolled patients.
  • The Challenges Of A Supply Chain Manager In An Evolving Clinical Landscape Effectively planning and executing a successful clinical supply chain is a complex task inundated with key decision points that have significant consequences for a clinical trial.
More From Pharma Logistics White Papers & Articles

PHARMA LOGISTICS APPLICATIONS & STUDIES

  • Challenges Of Pharmaceutical Temperature Control Distribution
    Challenges Of Pharmaceutical Temperature Control Distribution

    A US biopharmaceutical company approached Almac to assist with the EU product launch of their high value, orphan drug product. As the drug product was temperature sensitive with minimal allowable temperature excursions a key deliverable of the project was to design and qualify a temperature controlled shipping solution to ensure delivery of the production optimum condition. Throughout this case study Almac will highlight the challenges that arose and will provide solutions on how these challenges were overcome to facilitate a successful product launch.

  • Achieve Continuous Supply Of Drug Treatment For Study Requirements
    Achieve Continuous Supply Of Drug Treatment For Study Requirements

    A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.

  • Case Study: Simplifying Data Management In A Complex Study For a Global trial, our customer worked with multiple players, including affiliates and an external CRO.
  • Data Driven Market Success A Quintiles customer needed an experienced post-marketing ally who could plan for the unknown and design an observational study to eventually include several affiliates, thousands of sites, and more than 55,000 patients, with start-ups staggered over time.
  • Aptuit Blister Packaging Case Study A client, in need of global blister packaging, had received an exorbitant estimate from a Clinical Packaging and Logistics provider other than Aptuit.
More From Pharma Logistics Applications & Studies

PHARMA LOGISTICS SERVICES

TrialMax Web™ eCOA (Electronic Clinical Outcomes Assessments) TrialMax Web™ eCOA (Electronic Clinical Outcomes Assessments)

TrialMax Web™ is a web-based diary specifically designed for late phase trials, which tend to be larger and longer in duration.

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CONTRACT PHARMA LOGISTICS SUPPLIERS

  • World Courier Management
    World Courier Management

    World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.

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 PHARMA LOGISTICS & CONTRACT PHARMA EVENTS

Clinical Study Requirements – Understanding Differences Between the US and EU July 25, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Simplifying Your Quality System While Implementing ISO 13485:2016 Requirements – Strategies for Success July 27, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Drug Development 101 – How A Drug Is Made August 3, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
ICH E6 Addendum R2 Team Training and Action Planning August 7, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
Cell Therapy: Process Design Considerations To Support Commercialization August 9, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Effective Batch Record Review - Getting It Right The First Time August 14, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Using Social Media for Patient Recruitment in Clinical Trials August 15, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum August 21, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
Outsourced Pharma August 22 - 23, 2017
San Diego, CA
How To Establish The Number of Runs Required For Process Validation August 23, 2017
1:00 - 2:00 PM EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
The Impact of "Brexit" On Clinical Research – An Operational Readiness Primer August 24, 2017
1:00 - 2:30 PM EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Monitoring Plan Development: Post ICH GCP E6 (R2) Addendum August 25, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
FDA GMP Inspections – Proven Preparation & Survival Techniques August 29, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
EU vs. US GMP: Understanding Major Differences Post FDA/EMA Mutual Recognition Agreement September 6, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Conducting an Effective GCP Audit of a CRO-Managed Ongoing Study: Tips and Suggestions September 7, 2017
1:00 - 2:30 PM EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!