Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Leveraging Expertise To Exceed Immunotherapy Customer Goals

  A biologics company needed a CRO with a dedicated oncology team to manage its Phase I, multi-center study to evaluate the safety and pharmacokinetic (PK) profile of an immunotherapeutic drug in subjects with advanced solid tumors. They found a clinical trial partner with oncology experience that could support protocol design and accelerate the start-up process to meet a quick first-patient-in (FPI) milestone.

• 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.

• eCOA Trends To Watch

  With acceptance of personal electronic devices (e.g., smartphones and tablets) by the public, the use of computerized systems to collect clinical outcomes assessment (COA) data in clinical trials is commonplace and becoming the preferred and recommended method. As the regulators continue to encourage its use in clinical trials, eCOA deployment will continue to evolve. Read more about hot eCOA topics that demonstrate the trend toward patient-centricity are described here.

• 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.

• Liqui-Flux Case Study: Large-Scale Treatment Of River Water For Industrial Use

  Ultrafiltration (UF) is commonly used as a pre-treatment to Reverse Osmosis (RO) to ensure reliable, consistent and efficient operation. As Shandong Hongxin Chemicals Co., Ltd in China recently discovered, this consistency and reliability, along with quick setup and installation times, helped them realize convenience and cost savings.

• Markers And Methods To Verify Mesenchymal Stem Cell Identity, Potency, And Quality

  This white paper defines and discusses the evolution of MSC nomenclature and provides a detailed description of MSC markers and how they may vary by tissue source and species. Learn how to standardize MSC characterization by selecting markers for isolation, characterization, and validation.

• CCI Test Method Validation For Pre-Filled Syringes

  Regulators are paying closer attention to the proper design of robust Container Closure Integrity (CCI) studies and the validation of CCI test methods. 

• Mitigating COVID-19 Risks In A Complex, Fast-Moving Pain Program

  A cutting-edge biotech was running a program with three active, concurrent, pain studies across 25 sites and 218 patients, with interim database locks scheduled during the summer of 2020 and final database lock deadlines looming close behind. The COVID-19 pandemic put that all on the line.

• The Biotech And The CDMO: The Case For An Early Partnership

  Biotech investigators can’t possibly know everything required to move their drug candidate from the lab bench to the marketplace. Accepting that reality is the first step toward finding a strategic partner whose broad knowledge base and experience complements your specialized expertise. Whom you partner with, and when, can make all the difference down the road.

• Accelerating Discovery With Improved IP Management - Streamlining Lab Execution With BIOVIA

  Inefficient lab workflows and poor visibility across research data was threatening to jeopardize clinical programs, from discovery to registration and beyond for a biotechnology company. They needed to replace their legacy, paper-based processes with an entirely digitalized lab environment that supported the innovation lifecycle from target identification to compound discovery and process development.

• Emerging Pharmaco’s Dilemma: Make A Deal...Or Not?

  Take a closer look at funding strategies for companies launching products for the first time. Does partnering or "Going it Alone" make more sense for emerging companies? Read the findings of a 2006-2015 analysis, including implications for research companies, their potential large pharma commercialization partners, and venture capitalists.

• 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.