Newsletter | February 3, 2023

02.03.23 -- 4 Pitfalls To Avoid With RWD For Regulatory Submissions


Welcome to the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial MonitoringUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
Trial Monitoring
3 Best Practices For Actionable CRO Oversight

The ultimate purpose of sponsor oversight is to act when required. Audits, meetings, and documentation are not always enough. Too many sponsors seem to be forgetting that they are the customer, one that’s paying a heavy price for services that can ultimately make or break them. Reset the industry balance with these three best practices.

Digital Outcome Measures Of Physical Activity Approved As Primary Endpoint In Pivotal Cardiopulmonary Study

Bellerophon Therapeutics, a clinical stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, was able to save their clinical development program through the use of objective, continuous digital outcome measures.

Clinical Data Science For Non-Data Scientists (Part 1)

Explore how data science can be inconsistent with terminology and navigate the answers to the following questions: Is a given example best characterized as data science, or data analytics, or perhaps business intelligence? Do you need a data visualization expert?

Risk-Based Quality Management

Effectively plan and monitor clinical trials with IQVIA Technologies' configurable, SaaS-based solution that helps you mitigate risk and identify the next best action.

Clinical Data Management & Analytics
4 Pitfalls To Avoid With RWE For Regulatory Submissions

Despite the lack of a central catalog of all real-world evidence (RWE)-related regulatory decisions, there are a handful of product approvals and FDA reviews that highlight both the best practices and common pitfalls sponsors face. Avoid these four pitfalls.

The AI Revolution In Multivigilance

Explore how the life sciences industry is undergoing dynamic change thanks to advances in science and engineering.

Leveraging Clinical Trial Data In Real Time To Effect Change And Mitigate Risk

Learn how clinical trial data gathering, contextualization, and analysis can all benefit from existing — but underutilized — technologies and resources.

How Small And Midsize Biopharmaceutical Companies Can Easily Achieve Digital Innovation For Their Clinical Data

Discover how forward-thinking life sciences companies are defining their vision and looking for like-minded partners to execute information technology.

Preparing Data Packages For Regulatory Submission

Gain insight into how a dermatology specialized European CRO joined forces to carry out interim statistical analysis in its study on seven subjects and prepare necessary data packages.

Signals Line Listing Review

Watch how Signals Line Listing Review enables clinical study teams to review, query, and track the status of their line listings in a collaborative, centralized, and scalable environment.

Implementing A Scalable Data Linkage Strategy

Data linkage and tokenization at scale using Medidata Link effectively enables seamless integration into existing clinical workflows to provide linkage technology and capabilities for studies of any size and therapeutic area.

Clinical Data Management

Bioforum’s Clinical Data Management team is fully committed to providing high-quality and reliable services using the industry’s leading technology designed for quality data capture.