Featured Editorial

1. How Technology Has Changed Computer System Validation 11/11/2024

   "The Validation Specialist" Richie Siconolfi explores computerized system compliance in clinical research in this three-part series, beginning with a primer on two things: the predicate rules (regulations), guidance documents, directives, and guidelines; and the scientific method.

2. What's The Deal With eConsent? 10/11/2024

   Are you for or against eConsent? It’s odd that this technology has kind of become a polarizing topic in the clinical trials industry. To find out why, I decided to get some feedback from folks who have actually used it. 

3. Not What I Expected From A Vendor Conference 9/12/2024

   Dan Schell recounts some of his key takeaways after attending the Veeva R&D Quality Summit in Boston in September 2024. Some of the topics discussed include DCTs, eCOA, and the need to simplify tech integration at sites. 

4. KPIs To Consider When Evaluating Success With New Site Technology 8/22/2024

   Consultant Aurea Flores, Ph.D., offers specific advice for evaluating whether a new technology is embraced by site staff and fulfilling its purpose for the sponsor. 

5. How To Choose Fit-For-Purpose Tech With The Modified Delphi Method 8/19/2024

   When it comes to selecting a new clinical trial technology, consultant Aurea Flores, Ph.D. suggests stakeholders and end users explore options and make recommendations based on a modified version of the Delphi Method.

6. Early Planning Trumps eCOA Bells & Whistles 8/16/2024

   Julie Dietrich is a huge advocate for detailed documentation and early planning when it comes to successfully implementing eCOA systems. A good old-fashioned focus group couldn’t hurt either, she says.

7. Why We Need Technology Consolidation In Clinical Trials 8/16/2024

   As more and more trial designs incorporate technologies that generate an immense amount of data, data managers struggle to continuously interconnect disparate systems and standardize data. All of this fuels the need for technology consolidation.

8. Is Blockchain The Solution To Derisking Unreliable Clinical Trial Data? 8/16/2024

   Technological advances have provided fertile ground for scientific fraud, but blockchain just may be the key to ensuring a transparent, trusted, and certified process for collecting, managing, and analyzing clinical trial data.

9. A Quick & Easy Guide To Site-Facing Clinical Trial Technologies 8/15/2024

   Consultant Aurea Flores, Ph.D. summarizes some of the clinical trial technologies used by clinical research sites, their capabilities, and how sponsors and sites might best evaluate their use in clinical research.

10. What Sites Need: Trial Technology Integration, Support, And Evaluation 8/14/2024

    In part two of this series, SCRS Vice President of Site Engagement Jimmy Bechtel discusses how site technology should be chosen, customized, and eventually evaluated for success.