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WHITE PAPERS AND CASE STUDIES

• Improve Sterility Assurance And Data Integrity In A 503B Compounding Pharmacy

  Implementing automated technologies and robotics could be the solution 503B compounding pharmacies need to overcome growing issues with sterility and data integrity.

• 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.

• Data Integrity - Understanding And Becoming Compliant With GMP FDA Regulations

  Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. Understanding recent standards, guides and regulations pertaining to data integrity is essential to becoming compliant.

• Vertex Data Management Team Cuts EDC System Build Times By Half With Veeva Vault CDMS

  Read how Vertex Pharmaceuticals, Inc. reduced EDC database build times from 13-14 weeks for early phase studies to under 7.5 weeks today.

• Choosing A Formulation And Process Approach To Oral Controlled Release Products

  Do you want to develop an oral controlled release (OCR) product? If so, you’ll quickly realize there are a lot of questions to answer. Understanding the options and their ramifications is the first step toward devising a plan.

• Precision Powder In Capsule Micro Dosing Accelerates Drug Product Development

  Advancing active pharmaceutical ingredients (APIs) through the drug product-development lifecycle is fraught with challenges. Development timelines are tight, so it’s crucial to determine early in the process if an API is a viable candidate for clinical testing. A key tool that has emerged to address these combined issues of tight timelines and complex molecules is precision powder micro-dosing in capsules. This paper describes the use of precision micro-dosing to prepare API powder-in-capsule (PIC) dosage forms for oral or pulmonary administration.

• Clinical Data Transparency & Public Disclosures: Overcoming Challenges With Prospective Writing

  If a prospective approach is applied while preparing one document, it can support the creation of the other documents at a later stage. In this paper, we will discuss the development of document connections while preparing material for internationally regulated disclosure and how to apply this information.

• Empowering Success With A Common Operational View

  The Municipal Authority of Westmoreland County (MAWC) in New Stanton, Pennsylvania, provides service to more than 130,000 water customers and approximately 27,000 sewer customers. MAWC maintains more than 2,400 miles of water mains, three water treatment plants and eleven wastewater treatment plants. Over the past four years, MAWC has integrated geographic information system (GIS) applications to enhance project workflows and integrate datasets. Previously, while reviewing its construction workflow process, MAWC was frustrated to learn that project status was not being effectively communicated between departments, causing serious delays in inspecting and activating new hydrants.  

• Rapid Sterility Testing: Viral And Gene Therapy Applications

  For most cell and gene therapy products, a 14-day testing period for sterility is too long and hinders the timely release of products with a short shelf life or a small window for release to the clinic. Download this white paper to learn how validated, rapid sterility methods better address the needs of cell and gene therapy clients, with faster turnaround and increased throughput.

• Leading Biotech Company Reduces Time, Cost, And Risk With Medidata’s Site Cloud

  A leading biotech company with a strong commitment to developing and delivering innovative therapies for patients struggled to find a better way of sharing data once each clinical trial was completed. The answer was in an end-to-end solution to streamline and simplify the EOS media process.

• Strategies For Flexible Manufacturing

  Biopharmaceuticals are increasingly complex and on shorter timelines to meet patient needs. Here's an in-depth look at the latest market drivers, approaches, and technologies in flexible manufacturing.

• Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process

  This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.