The submit™ platform provides 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.
The SEND format enables more efficient review of nonclinical data, offering improved data quality, accessibility and predictability. The standard itself has been designed to provide a vehicle for more easily transporting to regulators the results of the majority of standard regulatory toxicology studies.
The introduction of SEND for both regulatory submission and the electronic exchange of toxicology data is having a significant impact on the industry and now that the FDA SEND Mandate for providing regulatory submissions in electronic format is in force, organizations must use the appropriate FDA-supported standards, formats and terminologies specified in the FDA Data Standards Catalog for NDA, ANDA, IND and certain BLA submissions. Failure to comply with the Mandate can result in the FDA’s technical rejection or refusal to file a submission, therefore, it is vitally important that organizations are SEND compliant.
As of March 15, 2019, new study types, such as Reproductive Toxicology and Safety Pharmacology, have been added under the SEND 3.1 standard for regulatory adoption.
In this period of change, Sponsors and CROs are faced with a growing list of choices for becoming SEND-compliant, which can be complicated to assess, have yet to be truly tested in the market and do not truly fit to their stage of SEND-readiness.
With a wealth of unparalleled experience in supporting companies to prepare for the standard, Instem provides organizations with clear SEND guidance at any stage of readiness with pragmatic, practical and proven solutions. Instem’s submit suite of tools and outsourced services is now the most widely adopted SEND solution in the market across 15 countries.
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.
Features & capabilities of submit™ include:
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.
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 becoming SEND-Ready, identifying specific approaches so as to maximize the benefits of SEND while ensuring they comply with regulatory guidance.
Across every stage of SEND-Readiness, clients can choose from one or more solution-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.