FDA Communications Through the Drug Development Lifecycle
As a drug makes its way through the development lifecycle, one of the most important relationships for a sponsor to
Consulting
Data Integrity – It’s All About the Data!
In this increasingly digital world, we have to remember data is now available in many different medians, including paper. When we think of clinical trials and the critical data
Why it is Critical to Have and Enforce a Data Strategy?
The Call to Action Data is the most important asset for a pharmaceutical or biotechnology company to produce during clinical
Optimizing a Clinical Development Program to Improve ROI
Clinical development proceeds in phases, and each phase contains a set of clinical trials. These trials, including their sample size
Steps to Implementing a Quality Management System
Steps to Implementing a Quality Management System Making quality not just an expectation, but an intrinsic and foundational element of
Diversity and Inclusion: Who is Responsible – Site, CRO or Sponsor?
Diversity and Inclusion: Who is Responsible – Site, CRO or Sponsor? Attaining a diverse trial patient population is crucial to
End-to-End Approach to Clinical Development
This white paper promotes an end-to-end approach through discussing Organizational design, Team structure, Process design, and Talent development programs.
Study Activation: Top Four Takeaways from Research Sites
While enrolling subjects is arguably the most crucial aspect of clinical research operations, this cannot be done without activating a
Vendor Management and Oversight of Clinical Trials
Discover practical guidance on vendor management, including vendor selection, risk assessment, and oversight to ensure trial success.
Addressing Barriers to DEI in Clinical Research
Breaking down barriers to participation in clinical research has long been a challenge, affecting every aspect of the industry. As
Developing a Data Strategy for Clinical Trials
This white paper outlines a data strategy specific to an organization’s unique needs and allows for adjustments as the organization grows and evolves.