The SENDTrial™ solution offers organizations of all sizes the ability to more easily create Trial Design domains, which are often difficult to create manually or through extraction from data collection systems. Used with Instem’s submit™ solution or deployed as an independent product, SENDTrial is a full Web based solution that can be accessed through a subscription via the Instem Cloud or internally hosted.

Making the complex, simple

SEND Trial Design domains can be some of the most challenging, time consuming and error prone domains to create. Data collection systems do not usually have the required information, and are unable to describe the study’s plan in a way that easily translates into SEND. SENDTrial can generate these domains automatically. 

• Easily create the Trial Design domains including: Trial Summary, Trial Epochs, Arms, Elements and Demographics
• Simply fill in an online questionnaire and have SENDTrial do the hard work of interpreting it into SEND
• SENDTrial comes with a default questionnaire already configured by Instem, but this is completely customizable to your own language and needs
• Each question comes with its own help text which can also be easily customized
• Produce an image of Trial Design Diagram for use in nSDRG
• Use templates to speed up the process even further
• Removes the need for manual creation or editing
• SEND terminology can be hidden, ensuring a wide range of staff can easily learn and use
• Questionnaire uses language familiar to nonclinical personnel, rather than unfamiliar SEND concepts and variables.

 

 

• SENDTrial™ Download Fact Sheet

• Request the 5-minute video demo Request the demo

SENDTrial offers a new approach – it becomes your SEND expert.
You simply give it the information from the written protocol that it needs, and it figures out the best way to render that study in SEND.

 

Our 5-step process to begin seeing value in just a few days: Sign up for a subscription to SENDTrial and login and set up your user details and security information Take the FastStart training provided by Instem With the written protocol document by your side, fill in the Study Questionnaire Have SENDTrial generate the SEND domains and the Trial Design diagram Include the XPT files in your study, and embed the Trial Design diagram in your nonclinical SDRG

SENDTrial - creating efficiencies, delivering results

Trial design domains are some of the most difficult SEND domains to generate, because:

• Much of the information required in SEND is not present in the data collection system and therefore not easily auto generated via the data extraction process. To work around this, some companies are trying to force as much SEND specific protocol information into their data collection system, even though it has no value to that system.
• Some companies are avoiding this simply by creating the SEND trial design entirely manually using something like Excel. This is extremely time consuming, error prone and is reliant upon highly experienced SEND experts, who are often in high demand for other SEND related activities.
• If using the approach of forcing SEND related data into the data collection system, the generated files will still need some level of manual intervention in order to get them submission ready
• When using the approach of forcing SEND related data into the data collection system, this typically only works for relatively simple studies. The more complex the study, the higher the amount of manual intervention needed, until the tipping point is reached where it is easier to just do it all manually.
• SEND has its own concepts (for example Trial ARM and Trial ELEMENT) which are based on the clinical model and are completely alien to the nonclinical study protocol. Therefore, it takes a high degree of both SEND expertise and non-clinical experience in order to know how best to accurately describe the study in SEND.

Until now, there have not been any tools available in the market to create the SEND trial design, which means that companies have been forced to rely on a significant amount of manual work to create these domains.

SENDTrial on the Instem Cloud

• Using the cloud based subscription model allows for immediate use without any installation
• No infrastructure needed – no database, no warehouse loading, no SAS installation
• Low cost start up
• True secure multi-tenant architecture
• Browser based access
• All major web browsers supported
• Remote support included
• Key-user Web-based training provided
• Cost effective licensing model
• No risk trials available

Value Add: Import Existing SEND datasets

SENDTrial can also import existing SEND datasets generated by any other system and then:

• Auto Generate the Trial Design Diagram for nSDRG
• Make corrections
• Add missing Trial Design details

Getting Started:

• Contact Instem and arrange to begin your subscription – payment can even be taken over the phone
• That same day, your private secure online environment will be created
• SENDTrial will automatically email a designated user with logon details
• A short training session will be arranged for your earliest convenience
• You can then use SENDTrial to generate the trial design domains for your first study