Electronic Submission Consulting
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| The era of the electronic submission is here! |
| Are you
ready? |
| Do you know the details and the pitfalls? |
| DataCeutics is a premier clinical technology organization that
leads you to successfully define and implement an eSUB
strategy. |
| With our proven record of submission experience, our intricate
knowledge of requirements and our expertise in state of the art
technologies, we will work with you to plan, organize and
implement the most cost-effective solutions available. |
| Even though there are now formatting and submission standards
from FDA, there are numerous details and implementation options to
consider. |
| Services include: |
- Designing and developing a complete strategy for electronic
submissions
- Developing processes, writing documentation and creating
data architecture
- Training on FDA guidance
- Integrating off-the-shelf tools with existing systems and
workflow
- Implementing tools for simple document conversion
- Developing patient profiles
- Constructing technologies that simplify and automate
numerous tasks
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