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The Eternal Struggle of Growth

Growth is a good thing, right?

When you care enough to have an opinion

We all hope to have employees who can think and operate independently, who want what is best for the business and who care about the organization and its members. Yet these are the same attributes that mingle to create and sustain organizational conflict. And conflict can either motivate change or completely debilitate movement and growth within an organization and among its team members.

How to Move eSubmission Ready Responsibility Upstream in the Process

Presenter: Marina Nisenzon, Senior Consultant, Process Solutions, Octagon Research Solutions, Inc.

Review of the FDA Guidance for Industry Integrated Summary of Effectiveness

Presenter: Jeff Davidson, Senior Director, Biostatistics, Octagon Research Solutions, Inc.

define.xml: Best Practices

Presenter: Lex Jansen, Senior Consultant, Clinical Data Strategies, Octagon Research Solutions, Inc.

Review of FDA Draft Guidance: Adaptive Design Clinical Trials for Drugs and Biologics

Presenter: Jefferey Davidson, Senior Director, Clinical Statistics, Octagon Research Solutions, Inc.

Avoid Your Next Submission Crunch – How to Proactively Prepare Your Documents

Presenter: Kyle Boelter, Senior Consultant, Process Consulting, Octagon Research Solutions, Inc.

The Roles of a Next Generation Data Standards Metadata Repository Webinar

Presenter: Barry Cohen, Senior Director, Clinical Data Strategies, Octagon Research Solutions, Inc.
Presenter: Lex Jansen, Senior Consultant, Clinical Data Strategies, Octagon Research Solutions, Inc.

Talking about Leadership Topics with Dan Silvert

If you work in Regulatory or Clinical within a pharma or biotech company, you are probably a member or a leader of a cross-functional product team. The idea of assembling cross-functional teams to address the various disciplines and detailed aspects of drug development really came into being in the early 1990s. Today, cross-functional teams are the foundation of most drug development organizations. Yet, leading a team of experts from very different backgrounds can be extremely challenging. Tight timelines and missed deadlines usually add pressure to this scenario.

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