Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Using ATP To Reduce Risks From Legionella In Cooling Towers

  A semiconductor manufacturing facility in France relies on an extensive cooling system to maintain stable conditions throughout their production facilities. The cooling system includes 19 cooling towers and 14 cooling water networks spread over a 135-acre site.

• Botanical Medicines In Research

  Botanicals have been used for millennia to combat illness—but why are there so few clinical trials testing the merits of this modality? This white paper describes rationale for why IRBs should embrace botanical medicine protocols.

• Increase Profits With Lyophilization: Reagent Kit And Diagnostics Benefits

  If your product uses cold chain logistics, requires user pipetting, or has a short expiration window, there are significant benefits to introducing a lyophilized version.

• Truck Dealer Group Drives Savings And Efficiency With Fleet Of Alaris S2050 Scanners

  Truck Country evolves from MFP-based document capture to a tightly integrated digital document management solution featuring Alaris Scanners in 20+ remote locations.

• Video Case Study: SPIRALIFT® SR Provides Septage Receiving Solution

  The Willits, California Wastewater Treatment Plant services over 10,000 residents and receives 750 loads of septage each year, but found they had a serious problem. Heavy septage from “honey trucks” was dumped by haulers into its wet well which clogged the plant’s pumps and caused flow channels to overrun. The plant also lacked oversight as to who was pumping and what was being pumped into its system. It could not control the pH level of the wastewater. 

• Phase 3 Bacterial Vaginosis Study

  Ensuring that studies meet the business goals of sponsors and increase the range of treatment options available to patients and healthcare providers can be challenging when a trial must enroll subjects with a bothersome health condition and ask them to risk randomization to placebo. The project team in a study of an investigational treatment for bacterial vaginosis addressed such challenges and enabled the study to meet the sponsor’s goals.

• When Other CROs Said No, We Said Yes — To The Nearly Impossible

  The sponsor was finishing its Phase III study for an antimicrobial, anti-infective drug and needed to complete its NDA submission in just 6 months. The development effort went back more than a dozen years, and having performed none of the clinical studies on the drug. This CRO took the unusual step of negotiating a rolling submission, providing by the due date enough information for the agency to begin its review, and filling in the rest over the following weeks.

• Expert Screen Review Instead Of Mode Equivalence Testing: Who Are These Experts?

  Electronic data collection is fast becoming the preferred method (versus paper) for capturing patient-reported outcome data in clinical trials. This transition necessitated expensive and time-consuming mode equivalence testing. But now, the process of “expert screen review” is being considered as a more efficient and less expensive alternative.

• Predictive Biomarker Signature Characterization

  A client was developing a new drug for complex neurodegenerative disease in pre-clinical development. The drug may be only effective for a particular subgroup of patients. They needed to generate a hypothesis on the molecular pathway and the targeted drug activity and identify a biomarker signature defining potential response to the new drug. Read how Cytel’s analysis produced a biomarker signature that was provided to the client for in-vivo validation.

• User Experience For Manual Injection Of 2 mL Viscous Solutions Is Enhanced By A New Prefillable Syringe

  Although subcutaneous administration improves patient compliance and quality of life by enabling at-home injections, as compared to intravenous or intramuscular route, the associated anxiety, pain, discomfort, and the frequency of injections can play a significant role in patient non-adherence with chronic subcutaneous treatments. In order to address these challenges, through reducing the required frequency of subcutaneous injections and increasing injection comfort for novel biotherapeutics, drug delivery systems are needed to enable the administration of large-volume injections and/or high-viscosity drugs. We developed a pre-fillable glass syringe featuring a stacked 8 mm needle with an ultra-thin wall (UTW) cannula technology as a solution.

• Controlling Dust In Grain Manufacturing Operations

  Aging dust filtration systems present safety and quality risks and low filtration efficiency. This case study shows how new dust collectors can maintain acceptable dust levels and reduce plant downtime.

• Adopting Label Change Best Practice To Promote Clarity And Compliance

  Globalized clinical trials are quickly becoming a pre-requisite for success. Read Almac’s latest case study to learn how one sponsor was able to extend its trial into new countries without risking labelling non-compliance, which enabled them to continue on their mission to improve the health outcomes for millions of patients.