Forms Processing

WHITE PAPERS AND CASE STUDIES

• Jeng Chi Chinese Restaurant Rolls Out New Tech And Rakes In New Profits

  Jeng Chi needed to upgrade out-of-date systems with relocation to a larger site and to help keep up with restaurant growth.

• A Top 10 Sponsor Improves Trial Data Quality Through EDC eSource Solution

  Be viewed as an industry leader while at the same time benefiting from higher quality data and a need for fewer resources with use of an innovative eSource solution.

• Overcoming Bioavailability Challenges In Oral Formulation Development

  With nearly 90% of developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must address this obstacle by applying approaches to improve an API’s pharmacokinetics. 

• Demystifying Extractables Testing

  It is critical anyone utilizing single-use technology understands the differences between the various guidances available for extractables analysis and which testing approaches are most suited to the study goals.

• Redefining Fast Melt For Pharma With 3D Printing

  Adults and children alike often struggle with compliance and acceptance of medication regimens due to the sizes and shape of prescribed tablets. One pharmaceutical manufacturer sought to create a convenient, easy-to-swallow dosage form by taking an alternative approach: three-dimensional printing (3DP). This white paper outlines their approach to creating an FDA validated manufacturing process for rapidly disintegrating dosage forms.

• Successfully Managing Disease-Specific Registries With eClinical Technology

  Healthcare technology company’s solution supports industry-academia collaborative registry and facilitates quick attainment of enrollment goals and generation of multiple publications.

• Single-Use Systems For Aseptic Fill/Finish

  Today’s disposable systems offer improved manufacturing efficiency, and better QA and regulatory compliance — and they can be the fastest route to media fills

• Inside Look: Halliburton’s Implementation of an End to End Solution

  Inside Look: Halliburton’s Implementation Of An End To End Solution

• Key Findings From The EMA’s Qualification Opinion On DDC

  The EMA’s qualification opinion on Direct Data Capture (DDC) is a huge regulatory development for the clinical research industry. Read our white paper for a quick understanding of the major points in the opinion, and of how DDC improves data accuracy, monitoring, and more.

• 505 (b)(2) vs. ANDA: How Complex Drugs Fit In

  Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.

• Key Concepts Driving The Future Of Single-Use In Biopharma Production

  This article discusses four topics related to single-use bioprocessing which are commonly cited by end users as amenable to future development. 

• Considerations For Clinical Studies In Migraine Prophylaxis And Treatment

  Migraine is a neurological disorder that compromises quality of life and is disabling for a large, predominantly female population. Read more about the important considerations, risks and mitigations in migraine studies.