Newsletter | August 22, 2025

08.22.25 -- 5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution

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Accelerate Your Trial Technology Decision

Join our virtual expo to explore top EDC, eCOA, and data management technologies—without the time, cost, or travel of traditional conferences. Watch 15-minute demos from leading vendors, ask live questions, and gain real-world insights to support faster, smarter decisions. Ideal for clinical operations, data management, and procurement teams, this event helps you compare solutions side by side and move forward with confidence on your next trial.

CLINICAL DATA MANAGEMENT & ANALYTICS

Data Overload: Determining Which Trial Data To Collect

Guest Column | By Rashida Rampurawala, Sanofi

Clinical trials collect a substantial amount of participant data, but not all of it is necessary. Learn how to decide what data's needed and what's not.

Data-Driven Decision-Making In Clinical Trials

Article | By Harshad Sodha, TFS HealthScience

By leveraging real-time data and predictive tools, sponsors and CROs can address the increasing complexity of trials, accelerate therapeutic development, and proactively manage risks.

8 Key Applications Of RWD In Multiple Myeloma Therapy Development

Application Note | Quest Diagnostics

How can therapeutic area (TA) datasets be leveraged to address the challenges multiple myeloma (MM) presents in the field of hematologic malignancies?

The SaaS Clinical Data Science Platform

Product | Revvity Signals Software, Inc.

Signals Clinical streamlines clinical data workflows, reducing the time spent preparing data for analytics. Its comprehensive platform enables the rapid delivery of clinical insights.

Reframing Clinical Vendor Selection

Case Study | By Joe Coffie, Coffie Consultants, ClinAI

Explore a platform that enables seamless vendor selection as well as cross-functional collaboration with built-in templates and tailored question libraries that simplify proposal creation and review.

Feasibility Insights In HR+/HER2 - Metastatic Breast Cancer

Case Study | Anju Software

This case study showcases how advanced analytics were used to streamline feasibility planning for a Phase II clinical trial targeting HR+/HER2- metastatic breast cancer as a second-line treatment.

TRIAL MONITORING

Running Global Clinical Trials? PolyPid Shares Operational And Regulatory Insights

Guest Column | By Dalit Hazan, PolyPid

PolyPid shares its clinical trial journey across the U.S., Europe, and Israel, highlighting operational complexities, regulatory navigation, and the adaptability required to execute large-scale, global studies. 

A New Approach To Clinical Oversight With Centralized Insights

White Paper | Medidata, a Dassault Systemes company

RBQM is transforming clinical trial oversight. By automating protocol digitalization, site selection, and risk assessments 360° Monitoring enables the proactive identification of CtQ factors.

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You're receiving the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial Monitoring. To make changes to your newsletter selections, update your topic preferences.

  • 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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