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WHITE PAPERS AND CASE STUDIES

• The Impact Of Artificial Intelligence On CQV

  AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.

• Topliss Sets In Drug Design Technical Notes For The Medicinal Chemist

  When considering new, innovative, and efficient drug design processes, you may want to review Professor J G Topliss's non-mathematical operational schemes for analogue design.

• 3 Ways To Address Sterility Assurance Requirements Of The EU GMP Annex 1

  Learn about the three key proactive steps companies need to take to meet the sterility assurance requirements of the EU GMP Annex 1 for the manufacture of sterile medicinal products.

• 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. 

• Streamline Recruitment With Confidence

  Transform your clinical trial recruitment with a service that delivers faster, more cost-effective enrollment, particularly for hard-to-reach populations.

• Research Site Network Enhances Study Startup With Reliable ICF Writing Services

  With help from a new informed consent form (ICF) writing partner, discover how CenExel Clinical Research was able to streamline processes and launch new studies faster.

• Top Therapeutic Areas In The Asia Pacific Clinical Trial Landscape

  Explore why the Asia-Pacific region has emerged as a clinical trial hub due to the ease of regulatory compliance, low trial costs, rising patient population, and the availability of top clinical institutions as trial locations

• Inspecting On The Edge — Understanding Punch Tip Wear

  Why is a horizontal optical comparator highly recommended for tablet manufacturers as a measuring tool for punch tip inspection, and what strategies can be used to detect, reduce, and prevent tip wear?

• Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study

  Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO. 

• Process Scale Column Packing Instructions

  Explore a comprehensive guide to using DurA Cycle A50, a high-capacity, alkaline stable protein A affinity chromatography resin for the downstream processing of mAbs and recombinant proteins.

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• Accelerating Rare Disease Trials With Biometrics Services

  Find out how one therapeutics company regained control over its data assets while increasing its ability to conduct comprehensive oversight and review activities across all data sources for faster decision-making and analysis time.