Healthcare

WHITE PAPERS AND CASE STUDIES

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Machine Learning In Intelligent Power Management Systems

  Machine learning for MCU implementation (Tiny ML) is transforming battery management and motor control by utilizing machine learning algorithms to analyze sensor data, optimizing performance and assessing system health.

• End-To-End Workflow Integration For Antibody Development

  Modern antibody discovery generates massive, fragmented datasets that slow collaboration and decision‑making. Examine how unified digital workflows streamline R&D and improve data quality.

• Democratize Batch Data Management For AAV Gene Therapies

  Explore a biotechnology company's process of choosing a data management solution that offered centralized batch data management, allowing the company to streamline its CMO data delivery process.

• Understanding Real-World Patient Characterization And Safety Outcomes Of DEXTENZA

  In this study, we can derive confirmation of DEXTENZA’s favorable safety profile across a broader surgical spectrum.

• The EMR Interoperability Dream Vs. Clinical Research Reality

  Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.

• American Academy Of Ophthalmology IRIS Registry Report

  The 2024 IRIS^® Registry Industry Report showcases the transformative power of real-world data (RWD) in ophthalmology.

• Improving Patient Health And Safety: Medical Affairs

  A medical affairs department needed leaders with scientific and project management expertise. With no time for training or risk tolerance, a consultant was hired to align activities with development and launch plans.

• eSource Purpose Is Not Just To Complete The EDC

  Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.

• 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.

• Escondido, CA Uses Cityworks And Esri's ArcGIS® For Its Asset Management System

  Read about water utility managers who took advantage of an offer from Trimble to do a pilot program for creating a ‘system of action’ that focuses on leveraging their investment in Esri’s ArcGIS® and water sensor data, location intelligence, and analytics tools.

• Advancing QC Efficiency With SEC-MALS System And Empower Software

  Discover how integration transforms lab workflows to enhance molecular characterization, streamline data management, and ensure compliance for superior data integrity and operational efficiency.