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WHITE PAPERS AND CASE STUDIES

• Meridian Builds Robust Gene Therapy Research Program By Leveraging Advarra IBC Services

  Partnering with Advarra’s Institutional Biosafety Committee, Meridian Clinical Research established a program for conducting clinical trials with cutting edge, genetically engineered vaccines. Download the case study.

• Effective Way To Ensure Early Statistical Deliveries

  A biopharmaceutical company had a first-in-human study in patients with solid tumors. They were in need of regular and timely reports to provied to the Safety Review Committee for dose decisions, to support rapid study completion. Cmed offered a solution by building an encapsia database to enable the sites to quickly enter their data and developed a robust and flexible set of programs to generate outputs required by the Safety Review Committee.

• Depositing - The Future Of Hard Candy

  Hard candy depositing is a process that has developed and grown rapidly over the last 20 years. Deposited hard candies and lollipops are now produced in every major confectionery market around the world by manufacturers ranging from regional specialists to major multi-nationals. This paper will review the basic principles of depositing and discuss the fundamental aspects of design that should be considered when engineering a complete depositing solution.

• Returning Study Results To Research Participants

  Studies show that most clinical trial participants want to know what was learned from their involvement. A growing number of sponsors are implementing plans to deliver plain language summaries to trial participants.  Read this white paper to learn about the current best practices for the content and preparation of plain language summaries, and the current guidance for how sponsors should work with Institutional Review Boards (IRBs) which have oversight of the clinical trials for which the summaries are provided.

• Which Real-World Research Design Is Best?

  Real-world research design is more complicated than clinical trial design, its complexity due to a multitude of factors including the differing evidentiary needs of diverse healthcare system stakeholders, the differing outcome measures available to meet those needs, and the differing methodologic approaches that can be used to collect clinical, economic and real-world data. Selecting the most appropriate and cost-effective research design can be quite challenging. Read more about a developed and tested an algorithm that has proven to be useful in structuring decision-making in the design of real-world research.

• 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.

• Electroporation Made Easy For Hard-To-Transfect Cells

  Despite its efficacy, electroporation is mistakenly under-utilized because of the perceived initial up-front cost in purchasing an electroporator and its association with high cytotoxicity.

• Lenovo Generates Significant Net-New Revenue In 6-Week Period With Katapult’s Innovative Financing Options

  Lenovo teamed up with Katapult to provide a lease-to-own financing option for this sub-prime customer segment. In the first six weeks after implementation, Lenovo generated incremental revenue through the new Katapult offering. Over the next few months, as the Katapult and Lenovo teams continued to optimize the new offering, completed originations from pre-approvals increased by 25 percent.

• Adapting To The Medical Monitor: Driving Tech Adoption In Clinical Analytics

  Reasoning for physician monitors’ reluctance, and what technology needs to offer to convince monitors their work can be more efficient: quickly detecting safety signals and speeding time to submission.

• Bringing The Freezing Of Biopharmaceuticals In From The Cold

  In this paper, we review end-to-end freezing solutions that integrate bulk filling, storage, shipping, thawing, and fill-finish operations to minimize risk and preserve product quality.

• 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.

• Bell Food Group Ensures Quality Of Burger Patties

  This case study shows how Bell Food Group, the meat supplier for an international fast food chain, uses X-Ray inspection to ensure burger patties are contaminant free and are of the highest quality.