Please Wait...

IRT Sourcing Models, Breaking with Convention (Part 1)

Technology Transfer Gaining on Saas

When it comes to Interactive Response Technology (IRT) – systems used to perform subject randomization, drug dispensing and study drug resupply – Software as a Service (SaaS) continues to be the conventional delivery model including here at BioClinica. However we're increasingly seeing progressive pharma and contract research companies take advantage of our Trident IRT as a technology transfer. In this collaborative arrangement, research organizations are able to do more activities with the IRT system on their own, giving them the higher level of control they want.

IRT Sourcing Models
Technology transfer is the process of conveying not only the technology, but also the knowledge, lessons learned, processes and expertise of one organization to another to help ensure success using it. The organization on the receiving end gains access to the technology and the ability to further develop it for their program needs. It is an alternative to the conventional SaaS model where licensing and subscription service are the norm and the application is centrally hosted by the provider.

Here at BioClinica, both our Trident IRT and Express EDC are robust technology transfer solutions. Within this model we pass on our extensive experience with thousands of studies and best practices to our customers to help ensure their success.

Recognizing that organizations have different needs, capabilities and resources when it comes to IRT, you have the option of choosing an "All In" approach or our highly flexible "Hybrid" approach. For quick comparison, here's what's included in our different IRT sourcing models.

             
 

Conventional SaaS

 

Hybrid IRT
Technology Transfer

 

All In IRT
Technology Transfer

 
 

BioClinica delivers everything needed for the Trident IRT system and end users.

Infrastructure, application, and personnel resources for the IRT system and services for specification, configuration, testing, and management.

Expert support services for the system, the data, and end users via our 24/7 US-based and multi-lingual Help Desk.

 

Project Management, IT, Study Build and QC responsibilities are shared among BioClinica and your organization.

Ownership is contingent on your capabilities, experience and capacity, as well as volume and complexity of studies being conducted.

You may determine "who owns what" on a study-by-study basis, including project resourcing.

 

Your organization takes full ownership of the Trident IRT system.

BioClinica provides the necessary training and resources to support success using Trident.

All resources needed to implement and support the IRT lifecycle are provided by your organization.

 
 

As you can see, technology transfer makes efficient use of your internal resources while providing a high degree of control over your studies. The model necessitates open and ongoing interaction with your personnel – the folks who generally know the preferences, work style, and traits unique to your organization better than anyone else. Using directly managed resources translates into involvement of fewer external parties, speeding your ability to respond to change – an important part of the equation when it comes to maintaining control and meeting timelines.

Which IRT Model Fits Best?
For anyone considering IRT sourcing models, keep in mind that different approaches have their own unique parameters and required skill sets. Whether or not your organization is a good candidate for one approach over another depends largely on your internal resources, namely information technology, project management, study build, and quality control as discussed earlier.

Hybrid technology transfer may be a good fit if you have in-house personnel with the experience needed to manage, build, QC and support studies. As for the infrastructure, unless you have the IT resources to truly own and manage the servers, the database and application setup and maintenance and change control, we recommend letting us take care of it for you. Hybrid may be the way to go if you already have in-house project management, study build and quality control resources with IRT or other regulated systems experience.

For those new to technology transfer, the Hybrid approach where BioClinica owns the infrastructure is generally recommended. The "All In" approach requires an IT team experienced in the regulatory compliance aspects and level of expertise most commonly found in mid- to large-size pharma companies and CROs.

Regardless which model is chosen, BioClinica provides training on the system and surrounding processes to help you become as successful using our technology as we are. In a Part 2 blog, Why Trident IRT Is Singled Out for Technology Transfer, I will explain the advantages of the technology and design behind Trident that make it particularly well-suited for this type of sourcing model.

Need help determining which sourcing model is right for your organization? Email me at Steve.Goldstein@bioclinica.com and I'd be glad to walk you through the options. Interested in learning more about BioClinica's IRT Technology Transfer approaches? Check out my on-demand webinar IRT: More Gain, Less Pain - Is IRT Technology Transfer Right for You?

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

Handy guide for the pharmacovigilance folks! https://t.co/tOyQWkiNhW
bioclinica (Yesterday)
#ClinicalResearch sites, REJOICE @bioclinica SMART Submit 4 cloud rsch image mgmt /subm is here! @OutsourcPharmahttp://ow.ly/odCh30grhnY
bioclinica (Yesterday)
What's next from Bioclinica? Hear if first during #PCTrials Europe next week in Amsterdam! https://t.co/ICngaxA9mg https://t.co/SXxPj3NpD2
bioclinica (2 days ago)
Join Bioclinica's Justin Hunt on Nov. 28 in a live webinar! Find out how to overcome common hurdles in CTMS impleme… https://t.co/wHfWHtI7sj
bioclinica (3 days ago)
Another CRO seeing big gains in the sites payments process! Access the Case Study here https://t.co/jsCxhmKcLo https://t.co/LpIKEtBKtE
bioclinica (3 days ago)
Great advice from our Dir. Cardiovascular Imaging on quality imaging acquisitions & assessments in clin trials. https://t.co/OVH7pZ3SL0
bioclinica (4 days ago)

Latest Blogs:

Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen
Congressman Meehan and Bioclinica CEO John Hubbard at recent visit to Bioclinica's Audubon offices