Web Content Management
Kits For LAL Testing Using The Kinetic-Chromogenic Method
The LAL Test (Limulus amebocyte lysate) is a method of great importance for the determination of endotoxins of bacterial origin.
At Fujifilm Wako, we manufacture kits to perform the kinetic-chromogenic LAL assay, which include all of the reagents necessary for bacterial endotoxins detection through a change in color development, and allow the customer to obtain accurate results in a short amount of time. To learn more about the principles of chromogenic detection in LAL testing we invite you to visit our blog.
TrialScope Transparency Management
Clinical trial sponsors are required by law to disclose information on their clinical trials in multiple places. These regulatory requirements continue to change as new mandated registries emerge and the scope of disclosure expands. This dynamic scenario creates a challenge for sponsors who must track and manage disclosure content that is being prepared for different registries, with different requirements.
Barracuda Backup - MSP
Barracuda Backup – MSP appliance is an all-in-one, subscription-based solution that simplifies data backup and recovery from advanced threats, disasters and human error. Also available in a virtual version, the appliance is flexible enough to meet the requirements of your customers running physical, virtual, and multi-site environments – all from a single, centralized management console.
Pharmaceutical Facility Site Analysis & Master Planning Services
Our cross functional teams of technical and subject matter experts, many of whom come from industry, have successfully collaborated with clients around the world to produce facility and site master plans identify the gaps between business needs and facility and site assets. Our proven five-step process of: aligning, collecting, analyzing, developing, and recommending achieves an outcome focused on the goals and objectives.
The right sites can make all the difference. At WCG, we help clients to identify, select, and engage the highest performing investigators for their clinical research trials.
WHITE PAPERS AND CASE STUDIES
Large PMA Study Of CRC Diagnostic
A study needed to enroll approximately 12,000 subjects and was also unique because it required subjects to self-collect samples at home. Read about the risk management and mitigation that Health Decisions utilized to keep the study on track.
BV Dairy Unleashes Growth With Epicor ERP And DocStar
Founded in 1958 as a family farm in England’s West Country, BV Dairy is now a thriving modern business. Each year, the company purchases 35 million liters of milk from dairy farms within a 25-mile radius of their production facility in Shaftesbury, Dorset and turns them into dairy products for food distribution and manufacturing firms. BV Dairy’s range includes their award-winning Dorset clotted cream, as well as yogurts, buttermilk, soft cheese, and mascarpone.
How A CRO-EDC Partnership Got Results For Study Sponsors
To deliver consistent results and ultimately create lasting relationships with sponsors, ARA needed fast and flexible eClinical tools. Medrio offered the ability to set up studies easily, collect data accurately, and make mid-study changes without study downtime saves their clients time and money - and increases the likelihood of repeat business and referrals.
Standardizing Principal Investigation Delegation Records: An Alternative Approach For Sites
In 2008 the US Food and Drug Administration (FDA) published Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects. The guidance document is specifically intended to clarify the FDA’s expectations concerning the responsibilities of clinical research investigators and sponsors regarding the supervision of clinical studies in which some study tasks are delegated to investigator employees, colleagues, or third parties. This article to briefly examine these responsibilities, with a specific focus on the delegation of authority, and to present methods clinical research organizations (CRO) can implement to effectively document the delegation of those responsibilities in compliance with FDA guidelines.
Capabilities For Clinical Studies In Contraception
Contraception studies involve a variety of unique operational and methodological considerations that may vary at different stages of development. This paper explains those considerations as well as key risks and mitigations in contraception studies.
Altus Research Maximizes Efficiency With eSource
By eliminating paper source documents from their daily site operations, the clinical research facility has enhanced data sharing, reduced administrative headaches, and ensured, for their clients, high-quality data that meet ALCOA and other attributes as described by regulatory authorities and GCP.
Enrollment Surpasses Projections In International Psoriasis Studies
A leading global pharmaceutical company selected IQVIA Biotech to support four international Phase III biologic studies in moderate to severe psoriasis. This team was selected because of a proven patient recruitment process with a record of enrollment that could save the sponsor time and money. Successful patient recruitment strategies in 13 countries, where some are unfamiliar with advertising, surpassed enrollment projections.
Taking Social Services Digital
County Department of Social Services — operating with a paper-based system for benefits applications and record keeping — finds itself overwhelmed by document volumes and logistical issues.
eRegulatory Experiences From A Site Without Binders
A clinical research facility had growing collection of bulky regulatory binders that was crowding them out of office space. Choosing a document management solution was easy. Read how they overcame the challenges of actually implementing the solution.
How To Avoid Last Minute CMC Roadblocks To Approval
Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. Because of their high-profile importance in development, clinical needs get the emphasis, while the many CMC needs and risks may seem less critical. This is a brief overview of the CMC information required by regulatory authorities and highlights why planning and budgeting for key CMC considerations early in the development process are essential for success.
Expanded Access For Delivery Of Treatment To Patients With Acute Adenovirus Infections Through A Named Patient Program
For sponsors, there are numerous operational logistics and regulatory approvals required in order to provide access to their medications through an EAP or CUP. In this case study, UBC deploys a global Expanded Access Program (EAP) to ease the burden on the sponsor and rapidly provide treatment to patients.
Five Essential Considerations for Efficient Clinical Trial Site Contracts and Payments
Insights on how to avoid startup delays, issues executing the clinical trial, or problems with making payments to sites.
Avalon GloboCare Announces Breakthrough In Identifying Human Angiogenic Exosomes/Extracellular Vesicles (EV) Derived From Endothelial Cells
Avalon GloboCare Corp. (NASDAQ:AVCO) (NASDAQ listed Avalon GloboCare AVCO), a leading global developer of cell-based technologies and therapeutics, announced today that its ongoing co-development program with Weill Cornell Medicine, led by Yen-Michael Hsu, M.D., Ph.D., Director of cGMP Cellular Therapy Facility and Laboratory for Advanced Cellular Engineering, has identified novel human angiogenic exosomes/extracellular cellular vesicles (EV) derived from endothelial cells
WCG Introduces Velos eResearch eXpress
The WIRB-Copernicus Group®’s (WCG™) Clinical Services Division introduces Velos eResearch eXpress™, an out-of-the-box, cloud-based solution that enables clinical research sites to centralize and manage their research activities on a single, automated technology platform.
Access Water® Launches As New Resource For Water Professionals
The Water Environment Federation has launched Access Water, a portal that organizes information and technical content critical to the water sector into a single, central location. The content is developed for and by water sector professionals and provides approximately 20,000 pieces of content, including conference papers, magazine articles, technical reports, fact sheets, compilations, and books.
World’s Most Powerful RF Emulator To Become National Wireless Research Asset
Over the past three years, DARPA’s Spectrum Collaboration Challenge (SC2) has relied on a custom-built virtual testbed called the Colosseum to host thousands of competitive matches and scrimmages, which will include the final match to determine the winner of the $2M grand prize.
Sonic Foundry Presents AV Over IP streaming On Integrated Systems Europe 2019
ISE stand 11-F140 - Sonic Foundry, Inc. (OTCQB: SOFO), the renowned global market leader for the creation and management of video images, will present its latest link between the video recording applications of Mediasite and NewTek's NDI® technology at Integrated Systems Europe (ISE) 2019, which will week takes place in Amsterdam