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WHITE PAPERS AND CASE STUDIES

• Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning

  The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.

• Standardizing Content Management Across The Life Sciences Industry

  Explore a quality reference model that aims to foster further standardization within the life sciences industry, and discover the advantages of leveraging the standardized best practices within.

• Accelerated Peptide Drug Development And Clinical Strategies

  Review how an integrated platform approach and innovative filtration strategies helped bring a novel therapeutic to Phase 1 clinical trials with reduced time and costs.

• Isolator Vs. Optocoupler Technology

  While optocouplers have been the dominant signal isolation solution for a long time, a new breed of higher-performance CMOS isolator solutions will ultimately out-mode the venerable optocoupler.

• Material Selection For Medical Device Manufacturability

  Choosing the right material in the earliest stages of research & development can make all the difference in beating your competitors to market and avoid increased project costs, development delays and manufacturing setbacks.

• Full Scale Operations For Parenteral Pharmaceuticals

  Explore how a project team accelerated through milestones in development, approval and execution of Equipment Evaluations, Equipment Specification Documents, Installation Qualification, and Operational Qualifications.

• Modifying The Micro-Environment To Improve Dissolution Rate

  Discover how modifying the micro-environment with targeted excipients can significantly enhance the dissolution rate of poorly soluble drugs using conventional manufacturing methods.

• A Review Of The Changing Trends And Use Of eCOA In Clinical Trials

  Delve into how electronic clinical outcome assessments are being transformed through new technologies, the maturation of digital organizations, and increased endorsement from regulatory bodies.

• How Digitized Protocols Are Accelerating Clinical Research

  Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.

• Increasing Bioavailability With Amorphous Solid Dosage Formulations

  Discover the challenges associated with pH-dependent solubility for oral tyrosine kinase inhibitor drugs and how leveraging ASD formulation can help create more effective, patient-friendly drug products.

• Matters of Scale: Centralized vs. Decentralized Manufacturing Of Advanced Therapies

  Reducing human intervention and manual processes in advanced therapy manufacturing is critical to improving a manufacturing paradigm, safeguarding quality, simplifying processes, and improving efficacy.

• Performance Of A Customizable DMSO-Free Cryopreservation Media Formulation

  Cryopreservation enables cell therapy by storing cells long-term. A DMSO-free formula preserves cell viability and health, minimizing toxicities linked with traditional cryoprotectants.