Newsletter | November 8, 2024

11.08.24 -- Automation: From Protocol Definition To Submission

TRIAL MONITORING

Insights Into TMF Challenges & Solutions

From The Editor | By Dan Schell, chief editor, Clinical Leader

In part 2 of this two-part Q&A, Nicole Palmer, CEO and president of consulting firm Granular Level, gives some good career advice for TMF professionals and talks about TMF audits and the EU’s Clinical Trials Information System (CTIS).

Must-Have Tools For Complex Clinical Trials: An Essential Guide

e-book | Medidata, a Dassault Systemes company

From adaptive designs to real-world data integration, explore expert insights on the technology investments necessary to meet evolving study demands.

CLINICAL DATA MANAGEMENT & ANALYTICS

Automation: From Protocol Definition To Submission

Guest Column | By Brian Hermann, Narayanrao Pavuluri, and Donald Thampy, Merck

Three members of Merck's global clinical data integration team discuss how automating various parts of the clinical trial process can improve data integrity.

Maximizing Clinical Data Insights With Advanced Analytics Platforms

Article | Revvity Signals Software, Inc.

To achieve drug approval, trials must collect, combine, and analyze diverse data sets that support operational, safety review, risk management, and other analyses crucial to development.

Implementing ICH E6 (R3) In A Risk Averse Culture

Article | By Christina Dinger, ThoughtSphere

Get several pointers on how to facilitate a transition to an agile, multi-faceted, and continuous risk and issue management approach aligned with the Statistical Analysis Plan.

Revolutionizing The Conventional Manual Document Filing Processes

Brochure | Advarra

Discover a new way to streamline document management and guarantee compliance with regulatory standards, providing a robust and user-friendly solution for optimizing research processes.

How Viracta Therapeutics Transformed Operations With NetSuite

Video | Sikich

Explore how a virtual biotech company overcame their challenges with QuickBooks software by embracing a new system with automated processes.

Fast-Track Your Move To Oracle Argus

Brochure | Cencora PharmaLex

rapidLIVE for Oracle Argus is tailored to meet the specific needs of safety and clinical teams across various organizations, including biopharmaceutical, medtech firms, and CROs of all sizes.

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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)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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