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

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.

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.

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?

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

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.

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

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

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

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.

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.

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.

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.