Comprehensive Drug Development Project

Comments

"Knowing how to integrate CMC with Noncliniical and Clinical helps me to communicate better with those departments."

"It helps me keep the full scope in view, all the time."

"The regulatory backbone keeps us focused on what FDA and EMEA really need vs. all the questions we'd like to address in our development."

"It is so visual with the Gantt charts. I really like how the modules are organized.. how they unfold and collapse."

"All the specific, task-driven content and good explanations of what triggers which task...those are the biggest benefits."

"It's like having an industry guru on your desk, without having to pay outrageous consulting fees."

"It's a lot better than the plan we use internally. It comes from a different approach and has just the right amount of detail."

Drug Development Tools and Training

Get a better understanding of the drug development process through our comprehensive project plan template, supporting tools, and training options. Whether you are a pharmaceutical industry veteran with decades of experience or a complete newcomer with an uncertain idea of where to start, we have the tools to improve your understanding.

The Project Plan Template

The Project Plan template 2009 version is the foundation of our support. The specialized template has 13 modules with over 8300 tasks, neatly organized in collapsible, outline format. It is easy to see where you are going, and it is easy to see where you've been. That's important in a project that encompasses so many different areas of expertise, and spans 14 years from initial innovative idea to post-marketing support and add-on development. The template modules cover Discovery, CMC, Non-clinical, Clinical, and Regulatory steps, all linked to provide a coherent timeline on a regulatory backbone. It was developed by experienced professionals with decades in the industry spanning all major functional departments. It is built in Microsoft Project, giving you access to all the features with the comfortable user-interface of Microsoft products.

Featured in Applied Clinical Trials

This template was featured in a two-part article published in Applied Clinical Trials. The article highlighted the template's ability to keep projects on track and under budget, and how to accelerate a project's progress.

Typical Users

Download Template

You can download this template directly from this site and have instant access to knowledge that takes years to develop through day to day industry experience. Buy it now.

 

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