A suite of integrated tools and services for the creation
and management of SEND datasets and associated documents for
Contract Research Organizations (CROs) and Sponsors.
Submit serves the needs of both producers and consumers of SEND data. But, we have developed submit knowing that many organizations both create and consume SEND data in the course of their operations. The platform also supports the very wide range of demands that span the needs of the largest multi-national pharmaceutical organizations and CROs to the smallest organizations and their advisors.
Whether you are simply using SEND to get to a regulatory submission in order to move your R&D program forward or you see it as the vehicle to enable you to leverage your safety data to generate new insights, Instem can provide the support you need. Our data management and analytics products are sophisticated and designed to support regulatory queries as well as data mining. The workflow management aspects of SEND can automate the flow of SEND data into a data repository and/or onwards to your regulatory submissions system as required.
Features & capabilities of submit™ include:
|
The introduction of SEND for the submission of study findings to the FDA presents the industry with opportunities and challenges alike. Instem's SEND experts help organize, educate and guide clients to be coming SEND-Ready, identifying specific approaches so as to maximize the benefits of SEND while ensuring they comply with regulatory guidance.
Clients can choose from one or more services that will help them in their journey towards SEND compliance while minimizing the impact within their organization. This includes the option for organizations to completely turn to Instem as their fully-outsourced SEND department.
SEND Advantage Services include:
|
We invite you to take the next step to learn more about our SEND Solutions, simply drop an email to submit@instem.com.
