Refrigerating frozen drug substances for storage. Flexible, Stackable, Mobile, Coolable & Scalable.
Field Service Elements
The Next Wave Of Field Service
Optimize your field service operations from the back office to the field
YPrime’s IRT+ goes beyond traditional IRT capabilities of patient randomization and drug supply management with control and a real-time view into critical functions and flows of a clinical trial - involving patient interactions, site activities and clinical supply management.
At Pii, quality is the foundation of everything we do. We strive to be a reliable commercial manufacturing and packaging partner by building exceptional quality systems matched by our well-designed facilities, proven technologies, broad expertise, and knowledgeable personnel.
Formulation Development CDMO Services
Our experience and capabilities in drug formulation development cover a wide-range of dosage forms and delivery technologies, including the formulation and development of tablets, and all other dosage forms.
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.
Light-Carrying Chips Advance Machine Learning
In the digital age, data traffic is growing at an exponential rate. The demands on computing power for applications in artificial intelligence such as pattern and speech recognition in particular, or for self-driving vehicles, often exceeds the capacities of conventional computer processors.
Corecon Technologies Announces Rebuilt Mobile App For Its Construction Software Suite
Corecon Technologies, Inc., a leading provider of cloud-based construction estimating, project management and job cost software, has released a new Corecon Mobile app.
ASG Technologies Advances Mobius Content Services Platform
ASG Technologies, a leading provider of solutions for the information powered enterprise, today unveiled the newest version of its content services platform, Mobius 10.1. This release advances ASG’s commitment to help enterprise and midsize firms manage and govern the explosive growth of their information while accelerating their business transformation success.
OMNIQ’s Ai-Based Vehicle Recognition Systems Selected For Los Angeles International Airport Modernization Project By HUB Parking Technology
OMNIQ Corp. (OTCQB: OMQS) (“OMNIQ” or “the Company”), a provider of Supply Chain and Artificial Intelligence (AI)-based solutions, today announced that the Company has received an order from HUB Parking Technology USA, Inc. (“HUB”) to provide vehicle recognition systems (VRS) technology for automated smart parking services at Los Angeles International Airport (LAX)
NAFA Fleet Excellence Awards Nominations To Close February 7
NAFA Fleet Management Association, the vehicle fleet industry’s largest trade association, announces the nominations process for the 2020 Fleet Excellence Awards (FLEXY) will close on February 7. FLEXYs are a well-respected fleet management industry award and a valuable opportunity to reward innovation and solutions that yield strong results.