Healthcare

WHITE PAPERS AND CASE STUDIES

• Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours

  The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.

• How To Recruit 236 Patients In An Osteoarthritis Study On Time During The Peak Of The Pandemic

  A leading Eastern European contract research organization completed the recruitment of 236 subjects in a Phase 3 osteoarthritis study for Handok Inc. despite hurdles caused by the COVID-19 pandemic.

• OPTICHECK Technology Built-In – Diagnostics, Verification, And Functional Safety With OPTIMASS Coriolis Mass Flow Meters

  State-of-the-art measuring devices such as OPTIMASS Coriolis mass flow meters combine robust measuring principles and powerful electronics to produce a wide range of readings and device-specific data. OPTICHECK technology built-in leverages the features of the devices to translate their available comprehensive measuring system data into sophisticated diagnostics information for plant personnel. 

• Empowering Freenome: Large-Scale Data Quality And Compliance

  Delve into five ways this biotech company was able to successfully deliver data quality and compliance for large-scale trials while developing next-generation blood tests for early cancer detection.

• How Medidata Link Is Supporting Moderna's Clinical Trial Real-World Data Linkage Initiatives

  Discover how Medidata Link empowers Moderna's clinical trial RWD linkage initiatives, enhancing insights into treatment outcomes while minimizing administrative burdens.

• Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study

  Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO. 

• A Guide For Quality Professionals In Healthcare And Life Sciences

  Discover a guide for quality professionals that highlights essential principles and strategies for maintaining data accuracy, compliance, and innovation to ensure high-quality data in healthcare and life sciences.

• Beyond Integration: Flexible Orchestration Of IRT And eCOA Solutions

  Consider how integrated response technologies and electronic clinical outcomes assessments can improve configurability, study start-up, and flexible mid-study changes.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• The Business Case For EHR eSource In Clinical Trials

  Examine how manual data collection challenges prompted the adoption of an eSource solution that streamlined data entry, saving time and costs, reducing errors, and accelerating a multicenter phase 2 trial.

• Patient-Focused Data Capture For Cancer Research

  In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.

• Providing Packing And Blinding Solutions For An Innovative Drug Start-Up

  Discover how a CDMO with integrated services enabled a botanical drug start-up to commence its Phase 1 clinical trial, paving the way for further advancement of its innovative botanical drug.