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WHITE PAPERS AND CASE STUDIES

• Patient-Defined Recruitment: The Movement Advanced By COVID-19

  The pandemic forced the pharmaceutical industry to reimagine how we recruit patients to clinical trials – and it's delivering significant benefits to sponsors who embrace these changes.

• Understand Total Cost Of Ownership For Cleanroom Modality Decisions

  Are you seeking guidance to evaluate cleanroom design/built parameters? Learning the total cost of ownership (TCO) and cost-benefit basics is a good place to start.

• Global CRO Drives Study Startup Efficiency By Converting Local IRB Sites To Central IRB Review

  Research sites that rely on a local IRB typically take at least twice as long to activate than sites that rely on the study’s single central IRB. Utilizing the central IRB not only helps to streamline study startup but also enables increased efficiencies in managing sites throughout the study’s lifecycle. 

• CDMO Grows 20% From Laboratory Instrumentation Provider Partnership

  A partnership facilitated capacity, efficiency, and compliance of pharmaceutical manufacturing and analytical service increases for a prominent CDMO.

• CRO Leverages Partnership With Integrated Central IBC To Initiate Sites

  Discover how a CRO was able to reduce study startup timelines and deliver trial results to the sponsor quicker than expected.

• The Foundation Of Peak Performance

  In this case study, read about an underdrain system that continues to operate as expected after 16 years of operation and appears to be in perfect condition. 

• X-Ray Inspection Of Frozen Burgers

  Meat and convenience products processor installs x-ray inspection solution to satisfy increased customer requirements and demands in terms of quality assurance and production capacity.

• Understanding The RTF Letter

  The development of new treatments, both drugs and biologics, is a long and arduous process, which can take many years. There are two major obstacles to getting approval and market authorization: the Complete Response Letter and the Refuse-To-File (RTF) letter. Explore the RTF process and how an RTF letter can be avoided.

   
• Biotechnology Manufacturing Program Management

  Find out how a global biotechnology manufacturing company executing several interrelated projects achieved critical project objectives while adhering to schedule and financial commitments.

• How To Run Successful Clinical Trials In Japan

  Read about why there is no longer any excuse not to include Japan as an integral part of any global clinical-development program for either pharmaceuticals or medical devices. 

• Learn How Compliance-Ready LC-MS Workflows for Oligonucleotides Can Expand your Analytical Services Portfolio

  CMO invests in solution to ensure data integrity and meet regulatory requirements as they expand their oligonucleotide manufacturing and analysis services.

• Creating A Biosafety Cabinet Training Program

  This article provides information for creating your Biological Safety Cabinet (BSC) training program, a list of resources and videos, and how your BSC manufacturer could provide additional resources.