Increasing demand for speed while achieving quality results has made partnerships an essential component of today’s clinical trial environment. An ideal Interactive Response Technology (IRT) partner will make the complex processes of subject and inventory management simpler and easier to manage, saving your project team and clinicians time so they can focus on your study.
The ideal partner should be flexible, supportive, and adaptive to meet your needs while maximizing support for your investigative sites, so when choosing an IRT vendor, look for capabilities that will augment your team’s situation and resources.
Key areas important to a good partnership include:
- Financial Terms
- Support and Service
Partnering starts early, even before the contract is signed. The signs of an effective working relationship can be evidenced during the demo and RFP process. A good IRT solutions partner will respect your confidential information, provide a demo, answer questions, and send a prompt response to your RFP.
Before sharing information, a key step in developing a good partnership is to put a confidentiality disclosure agreement (CDA) in place. This protects the information shared by both parties; this typically follows the laws of the country where the IRT vendor resides.
The IRT vendor will then provide a demonstration of the system. This is an important step, as there are differences in system capabilities and how easy they are to use. You’ll want to look for a clean interface and intuitive, user-friendly design, as this will save your organization training time and frustration.
Some key questions you may want to ask during the demo:
- How is data displayed and exported; can it be accessed quickly and easily without using queries or another system to view it?
- How is unblinded information managed to avoid unintentional bias or unauthorized unblinding?
- How will the study team and site users be trained?
- Is the data easily transferred to your chosen EDC?
- How easily can changes be made to the system throughout the study?
- What type of end of study reporting is included?
There are many system questions you’ll want to ask, and your ideal partner will walk you through their system and make sure you get the answers you need. The goal of the demo is to help you evaluate whether the system will fit the needs of your study requirements.
A good potential partner will respond to your RFP promptly with comprehensive information. They will look over the protocol or synopsis in the RFP and develop their proposal quickly (one or two business days) – giving you the information you need by the date that you need it. The proposal should include system capabilities, organization support, and financial terms.
The IRT solution should include the range of capabilities adapted to the CRO/sponsor’s needs as outlined in the synopsis. A well-designed IRT system includes a validated core system and modules that add specific functions, so you’ll want to check to see if the IRT vendor offers all the capabilities that your trial will need. These may include:
- Subject Management
- Subsequent IP Assignments
- Cohort Management
- Subject Diaries
- Activities management
- Inventory Management
- Shipment Requests/Receipt Confirmation
- IP (Kit) Management
- IP (Kit) Accountability
- Min/Max Inventory Management
- Predictive Inventory Management
- Temperature Deviation Tracking
- Site Management
- User Management
- Configuration Options
Look for software that allows assigning roles that limit the ability to view and edit only the screens and activities pertaining to the individual’s job; this is helpful both to simplify tasks and prevent errors.
The RFP response should be clear on what is included in the project and what could be added at additional cost, for example, optional modules or any custom coding that may be needed.
Depending on your needs, a modular system that allows you to choose and only pay for the capabilities that you need for your project can be your most cost-effective option.
Some other areas that might impact the total cost include how start and stop dates are defined, how flexible the vendor would be if the study is postponed or canceled, and what costs are incurred if change orders are needed.
Who will support your team is as important as the IRT system itself. Look for experience, training, and the level of assistance, for example, if your trial will be conducted in seven countries, look for an organization that has supported many international clinical trials. You’ll want to know who your project manager will be, if you will have one primary point of contact, and if they are an experienced team member. In addition, the RFP response should specify what type of training and support can be expected.
The startup phase is critical
A good IRT partner has the knowledge to guide your team through a startup process that is quick, efficient, and successful. Leveraging their specialized experience, your IRT partner can save you time by advising you on specifications and necessary steps to document and set up your trial, so you don’t miss milestones.
A comprehensive process will likely start with a Master Service Agreement (MSA). The MSA is like an umbrella agreement that lays out expectations for working together, preventing misunderstandings that could cause lost time during the project. The MSA further clarifies financial terms, warranties, and confidentiality that is going to be needed. This is key for transparency and a smooth working relationship.
Once the MSA is in place, it covers subsequent projects, which will save you time in the future.
With the MSA in place, the next step is to quickly complete the Service Order (SO). This is an agreement specific to the project and clarifies items such as set-up, the modules that will be used, the monthly maintenance fee, and any milestones payments.
An ideal IRT system partner will build a good working relationship with you during the entire course of the study. They’ll start by assigning an experienced, dedicated Project Manager (PM) and back up PM to your project. The PM is your primary contact and works with you to determine the specifications of your project, creates the User Requirements Specification (URS), and acts as your ‘champion’ throughout the project. The PM works with the project team during development and testing to ensure timelines are met. The PM will continue to be available to your project team throughout the life of your project.
The PM will initiate a kick-off meeting to introduce team members, clarify roles/responsibilities, and explain processes for obtaining the Subject Randomization and Clinical Trial Material lists and information gathering for the User Requirement Specification. After the requirements are gathered, the developer will program the first build. The first build of the system should be demonstrated and reviewed with your team.
At this point, your team may suggest minor changes as needed. For example, they may want to change how a specific question is worded.
The IRT system partner should also provide your team with a Validation Summary Report (VSR) so you can review any issues that arose during their testing. A thorough VSR will display the errors found during the Validation team’s testing and confirmation that the errors were corrected (that is, re-tested).
The more thorough a job the Validation team does, the smoother your own testing will be. It is much better if the Validation team finds and fixes any errors before your team does, which will ultimately save you time during your User Acceptance Testing.
Training and 24/7 support
Your IRT partner should provide training and support, at the beginning and all through the process, guiding you every step of the way. Even if your chosen partner has a system that is easy to use, some questions will arise, and changes will be needed. As the study progresses, the IRT system and team should be able to make data and configuration changes quickly and effectively to keep your clinical trial on track.
Types of Changes:
- Data – Some data changes can be made by the sites, like adjusting the date of Screen failure or Discontinuation, or modifying demographics that don’t impact strata or randomization. Other data changes must have signed approval before the helpdesk can make a change, i.e. changing the status of a kit from temperature deviation to available.
- Configuration – adding system privileges to a system user or changing the number of days before an activity is out of the target window.
- Code – Adding or removing functionality to the system based on a new protocol amendment will typically involve a pass-through cost to the customer and will require a signed Change Order.
And since clinical trials are often run in multiple time zones or even around the clock, help should be available 24/7, via both email and phone.
IRT solutions can make many aspects of the clinical trial process faster and more efficient. Choose wisely, as the partner with the team and tools that best fit your needs will make a positive impact on the time and expense associated with running your clinical trials.