Insights On Clinical Technologies

  1. Artificial Intelligence And Machine Learning/Translation In Pharma Language Translation 11/12/2019

    AI is being used to model, extrapolate, and automate tasks throughout the lifecycle of a drug (as it should be). The potential benefits are substantial, both in terms of clinical efficacy and financial savings. With all of the supposed power and promise of this advanced technology, what are the real, practical implications for clinical outcome assessments?

  2. Pharma Company Improves Resource Management And Portfolio Planning 6/26/2020

    How a $23 billion publicly-held global specialty pharmaceutical company leveraged a software application to strike balance among its clinical studies portfolio, resources, and budget.

  3. Data Standardization For Late Stage Development And Periapproval Studies 7/10/2019

    Now more than ever, especially in rare disease populations, and as manufacturers look to add many different types of data from a variety of sources. Challenges exist when data with differing data elements from a number of sources (EDC, registries, claims, HCPs, pharmacy, lab, etc.) converge. Therefore, standardization of the data is paramount in generating evidence to benefit patients, especially rare disease patients, where population size is limited.

  4. Exelixis Deploys InForm To Help Stabilize Their Clinical Study Process 6/1/2020

    This biotechnology company chose this solution to assist with user management and configuration with IRT. Looking ahead they hope to be able to expand its use including integrating with their safety system.

  5. Expert Screen Review Instead Of Mode Equivalence Testing: Who Are These Experts? 1/7/2020

    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.

  6. GE Healthcare Adopts Oracle InForm To Save Money And Time 6/1/2020

    By implementing this program GE can monitor in real time the number of investigator sponsored research contracts and GE sponsored studies.

  7. Is Pharma Ready To Embrace Virtual Trials? 6/21/2020

    Now is the time for pharmaceutical companies to take a look at the best approaches for designing and implementing virtual clinical trials. Using a virtual approach to clinical trials has the potential to improve patient experience and data quality while also accelerating the time it takes to get new drugs on the market.

  8. REMS Technology Of Today And Tomorrow - Transformative Solutions To Help Reduce Burden And Improve Safety 2/5/2020

    During the 12th REMS Summit in Virginia, UBC’s Natalie O’Donnell, Corporate Vice President, Safety, REMS, and Strategic Engagement and Justin Wilson, Director, Software Development and Technology, presented a session on the impact technology has had on REMS and the potential effect it can have in the future. 

  9. Ensuring Compliance With Part 11: A Site’s Perspective 7/9/2020

    As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.

  10. The Accelerated Evolution Of Clinical Trials In A Pandemic Environment 11/25/2020

    To explore the impact of the current environment on clinical trial management, we surveyed professionals involved in clinical trials at biopharmaceutical companies, medical device companies, and CROs based around the world. The research results provide valuable insight into how the COVID-19 pandemic is changing the way clinical trials are being conducted, and identifies the key challenges and opportunities surrounding these changes.