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

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:

SEND Advantage Services

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:

  • SEND Deliver™: Leveraging new processes, a larger team, and leading proprietary technologies, Instem rapidly turns manual or electronic data into SEND with all supporting documentation & metadata.
  • SEND Comply™: Conformance checks, dataset verifications and remediation services performed by our team of SEND experts.
  • SEND Advise™: Tailored on-site or remote consultancy and education programs.
  • SEND Warehousing Services: Transforming legacy data into structured datasets that provide value beyond compliance.
  • SEND Source™: Flexible SEND partnership programs that offer professional staff augmentation, partial or full outsourcing services.

We invite you to take the next step to learn more about our SEND Solutions, simply drop an email to submit@instem.com.

Submit Platform Sheet

On-Demand Recordings

Case Studies

Submit Platform Fact Sheet

On-Demand Recordings

Case Studies

Sensible SEND Blog

Submit for Sponsors

For Sponsors

On December 17, 2017, the FDA SEND 3.0 Mandate for providing regulatory submissions in electronic format came into force. All organizations must now use the appropriate FDA-supported standards, formats and terminologies specified in the FDA Data Standards Catalog for NDA, ANDA, IND and certain BLA submissions. Additionally, as of March 15, 2019, new study types, such as Safety Pharmacology, have begun to be required by FDA.

Whether you run your own studies, outsource everything or a blend of the two, our efficient and compliant solutions have been designed to streamline your operations and minimize the costs of compliance.

The submit™ platform provides configurable components that enable you to create workflows to match the study data sources and processes that support your mission-critical submission processes.

CRO-sourced datasets can be:

In-house data can be:

Retrieved from a secure location

Converted to SEND using one of our source-specific adapters

Checked using either your specific SEND checker rules or the OpenCDISC checker

Merged with SEND or data from other sources

Queried more efficiently

Supported with automatically generated DEFINE.xml files and Study Data Reviewers’ guide

Combined with data from other sources

Visualized in our purpose-built QC tool, SENDView™

Stored in the secure file store along with meta data and SDRG

Passed into the submission workflow or onwards to other systems and recipients

Submit for CROs

For CROs

Whether you are creating FDA-ready SEND datasets or SEND datasets to meet the specific requirements of a sponsor, Instem’s submit™ platform offers both software and professional services to support the efficient and commercial creation and management of datasets.

We understand that the time required to create final study documents is crucial for the success of CROs. Our consultants work with you to make sure, whether you are using our software or our services, that the workflows we implement provide you with excellent value for money as well as ensuring that you are able to meet the expectations that you have set with your customers.

For CROs, the submit™ platform provides tools to accept data from any electronic source system and to convert that data into SEND datasets. We can blend together data collected in standard In-Life collection systems with those from specialized analysis systems and data provided by, for example, contract pathologists to generate a single combined dataset.

The submit™ platform has been designed to support CROs of all sizes and specializations, which means that you can select components that:

  • Create SEND direct from leading toxicology software solutions
  • Create SEND from a wide range of electronic source formats
  • Execute standard and configured SEND validation tools
  • Manage and track the QC process for SEND datasets
  • Store and manage contributing datasets from a range of internal and external data sources
  • Store and manage SEND datasets and associated metadata and documents
  • Forward datasets to specified locations

SEND Price Check

CROs, has one of your sponsors asked if their study can be returned in SEND ahead of you being SEND-Ready™? Touch base with us and we can give you an immediate quote for converting the study.

Virtual Appointment

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Virtual Appointment

To help you better evaluate our software or services, we believe an initial, no pressure Web session is the way to go.

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We are excited that you have decided to take the next step with Instem. To provide you with an accurate quotation, we ask that you fill out our form.