Forms Processing

WHITE PAPERS AND CASE STUDIES

• Insmed’s Fast And Successful EDC Study Builds With Veeva Vault CDMS

  Insmed describes the critical success factors enabling them to incorporate significant protocol changes and still hit their FPI deadline with Vault EDC.

• A Deeper Look At Automated Treatment Plant Design

  Transcend Design Generator (TDG) is a custom-made design software system created by wastewater engineers. Its user-friendliness and accessibility enable those with no prior knowledge of wastewater engineering concepts to work alongside those with extensive experience. This allows users within the industry to generate and analyze complete preliminary wastewater treatment facility designs. Starting with the entry of a number of simple input parameters, engineering decisions take place in a completely automated fashion. To guide users throughout the data entry process, special data validation parameters are present to ensure data quality and consistency.

• Formulation Development Strategy For Early Phase Human Studies

  Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.

• Back To Basics: A Survey Of Clinical Data Management System Users And Decision Makers

  A survey was conducted, asking participants about their current pain points, current CDMS solutions, and features/functionalities they desire in a future CDMS. This white paper discusses the key results of this survey.

• Is Wurster Processing The Right Choice For My Multiparticulate Modified Release Dosage Form?

  Wurster processing is a common and appropriate choice for multiparticulate formats. But is it the best one? This paper outlines what you need to consider when determining whether Wurster processing is right for your multiparticulate modified release dosage form, as well as general information to assist in discussions with your CDMO.

• GIS: A Large Role At A Small Utility

  I did not have any experience with geographic information system (GIS) technology when I was introduced to Esri in 2016. I started my working career on my father's shrimp boat in the late 1970s, when work was scarce. I followed my father's path as a union pipe welder. Quickly I realized that my interests lay elsewhere. My family was a mix of fishermen, construction workers, and other skilled professionals, so I followed suit and delved into a little bit of it all. I found I really enjoyed working in the construction field and chose masonry.

• Recombinant Collagen Made Via Fermentation Addresses Unmet Market Needs

  The production of recombinant collagen made via fermentation-based processes addresses market needs for collagen that is safe, sustainable, reproducible, and acceptable to consumers. 

• eRegulatory: A Site's Perspective

  Coastal Pediatric Research (CPR) was well aware of the eRegulatory trend that was surfacing. Before CPR selected a platform, the team gave some thought to what they wanted an eRegulatory system to contain and/or provide. Learn more about the criteria for their selection and what solution met their criteria.

• Bio4C ProcessPad 21 CFR Part 11 Compliance White Paper

  Learn how Bio4C ProcessPad™ meets 21 CFR Part 11 requirements including unique usernames and passwords, timestamped audit trails, and secure storage of all records.

• Container Closure Integrity Testing Of Sterile Injectable Product

  This article summarizes the current state of container closure integrity testing in the pharmaceutical and biopharmaceutical industries and outlines possible approaches for developing a CCIT strategy.

• Mitigating Hidden Risks: Extractables And Leachables

  Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

• Liquid Handling Solutions For Bulk Drug Substance Management

  How modern containment technologies optimize and streamline bulk drug substance management workflows while ensuring substance integrity and safety.