eClinical Articles

  1. 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. 

  2. 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. 

  3. 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.

  4. 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.

  5. ICH E6(R3) And Defining What Is Critical To TMF Quality 4/9/2024

    By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).

  6. 3 Tips For Selecting Your eTMF Platform 3/7/2024

    Each eTMF platform presents its own set of advantages and drawbacks. Be sure to incorporate these three tips when considering a new eTMF vendor and its services.

  7. Balancing TMF Management After A Mass Layoff 1/16/2024

    Discover nine next steps for you and your TMF team to help address the uncertainty of layoffs and maintain an accurate and up-to-date trial master file.

  8. Establishing TMF Quality Goals For Greater Trial Efficiency 9/14/2023

    Does your clinical development group rely on its TMF as a resource for designing and conducting trials efficiently? Would maintaining timeliness in filing complete, ALCOA-compliant documents to the TMF be enough if efficiency were a goal of every clinical trial? Consultant Ken Keefer discusses the importance of creating TMF quality goals to improve overall trial performance.

  9. Understanding Data Collection And Management In Decentralized Clinical Trials (DCTs) 5/18/2023

    When it comes to wading into the muddy waters of a DCT, it's important to specify the risks up front and determine how decentralization is appropriate for each protocol. From a data collection and management standpoint, there is plenty to consider in terms of data flow management through multiple sources and systems.

  10. TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability 3/20/2023

    There is a growing desire within the clinical trials industry for better data integration — not just to help regulators, but also to help sponsors manage trials more effectively. The recent affiliation of the TMF Reference Model with the Clinical Data Interchange Standards Consortium (CDISC) may become key to making this possible.