eClinical Articles

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

    Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

  8. The 5Vs Of Collecting Clinical Data 1/26/2023

    Not all data is created equal. Our data strategies need to be commensurate with the risks, complexity, and value of the data collected. If the true value of data is to be realized, it must be collected and captured in accordance with the five “V” dimensions: volume, variety, velocity, veracity, and value.

  9. Life Sciences RIM: Modernization & Moving Ahead 9/28/2022

    Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.

  10. Takeda Takes A Strategic Approach To TMF 6/21/2022

    Over the past five years, Takeda has been perfecting its all-in model for TMF, where both Takeda and its CRO partners collaborate in Takeda's eTMF. This enables transparency into TMF health across the partnership and drives more effective, proactive collaboration.