Newsletter | March 22, 2024

03.22.24 -- Optimal Practices For Full Registration And Reporting On ClinicalTrials.gov

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EDC has become a premier clinical technology in improving data accuracy and reducing site burden through time and resource conservation. But which EDC do you choose? The market for clinical technologies has produced more and more solutions in recent years, making the selection process complex. Here, we showcase Medidata’s Rave Companion EDC solution presentation from our recent Clinical Leader Solutions Expo. Learn about your options for modernizing your clinical trials at your pace, on your schedule.

CLINICAL DATA MANAGEMENT

Optimal Practices For Full Registration And Reporting On ClinicalTrials.gov

Guest Column | By Kelly Franzetti, Clinical Trials Transformation Initiative

The Clinical Trials Transformation Initiative (CTTI), alongside the FDA, investigated factors and barriers to registration and summary results information reporting. Here is what they found and what they suggest for ensuring complete reporting.

Using AI To Speed And Simplify Site Validation

Article | Cognizant

Sites that lack the proper skills and staff can delay the delivery of drugs to the market. Discover how site validation can be improved by combining qualitative and quantitative data.

One Day, Clinical Trials Will Represent The Real World

Article | Komodo Health

What needs to happen for RWE to reach its full regulatory potential? We discussed this with industry leaders during the One Day Summit, and here are some key takeaways.

Time-To-Event Analysis In Oncology Through The Prism Of Estimands

Article | OCT Clinical

Considering an ICH E9R(1) Addendum on Estimands and Sensitivity Analysis, several sensitivity analyses are now regarded as supplementary analyses. Learn about these changes and their effects.

Facilitating Good Clinical Data Review In Your Clinical Trial

White Paper | Revvity Signals Software, Inc.

Start creating systems based on connectivity and automation, aggregated and usable data, flexible analysis, and methods of collaborative data review by centralizing analysis and communications.

Medidata Research Alliance: Partnerships For Medical Progress

Datasheet | Medidata AI

Delve into the strategic partnerships, collaborative models, and impactful work that define the Medidata Research Alliance and drive advancements in medical knowledge and patient care.

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Webinar: Advancing Development of New Oncology Therapies: Aligning with FDA’s Project FrontRunner

Join us on April 4th as we explore the risks and rewards of providing groundbreaking cancer treatments to patients with early advanced metastatic cancer. Our discussion will navigate the complexities of advancing treatments sooner, specifically the impacts on patients, investigators, and drug developers. Click here to learn more.

TRIAL MONITORING

The FDA Speaks Up For Quality Management: Must They Beg?

Guest Column | By Penelope Przekop, MSQA, RQAP-GCP

The FDA's quality by design (QbD) and risk-based monitoring (RBM) messaging began more than 10 years ago with their guidance on RBM. Eleven years, five total related key guidance documents, and one global pandemic later, why aren’t we moving forward at more than a snail’s pace? 

Modernize TMF Culture To Better Support Modern Clinical Trials

Article | By India Gardner, inSeption Group

Clear benefits emerge when the trial master file is made a more engaging and less overwhelming task for all who must collaborate to complete it.

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  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
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