IRT Clinical Trial Companies
IRT Clinical Trial Companies
Interactive Response Technology (IRT) companies play a key part in keeping track of the various elements involved in clinical trials.
IRT systems help to manage and monitor participant enrollment, randomization, and the drug supply chain. The technology that IRT uses works in different ways, according to the specific solutions offered by IRT providers. Randomization Trial Supply and Management (RTSM) experts can help with understanding how best to implement study design using IRT.
In this article, we discuss how to choose an IRT clinical trial company. How important are functionality, flexibility, and adaptability? Here we break down key qualities to look for.
What to look for in an IRT clinical trial company
Finding the right IRT partner presents clinical trials with a number of benefits. A good IRT can support the effective running of a trial: It can improve efficiency, reduce data errors and reconciliation effort, can provide data insights and upfront alerting, in addition to the core of ensuring randomization and treatment as per the protocol. An effective IRT can also help manage trial supplies; it can reduce wastage and effort required, avoid delays, and mitigate the risk of stockouts.
When searching for suitable IRT clinical trial companies, consider these factors:
Functionality
Does the system offered by an IRT company give you the functionality you need to effectively manage your clinical trial? This is one of the most important questions to ask when considering prospective IRT providers.
IRT systems provide functionality for randomization, participant management, drug supply tracking, data tracking, and real-time reporting. Most systems offer configuration, where existing pre-programmed options can be chosen, with some offering customization, where the design can be tailored to specific needs. With your trial’s specific requirements in mind, you can ensure that an IRT system aligns with your study protocol and offers the depth of functionality you require.
Timelines
Timeline considerations are also vitally important. The best IRT companies will be able to demonstrate quick implementation processes; with minimal downtime during system setups, and the ability to meet tight study timelines.
Vendor support & Integrations
The level of vendor support received can be fundamental to the success of clinical trials. A company that offers comprehensive support throughout your study lifecycle should be seen as advantageous.
Look for the assurance of user acceptance testing (UAT) support and detailed written test scripts for trial validation. Vendors who are able to assist with electronic data capture (EDC) and clinical trial management system (CTMS) integrations are also valued by many trial investigators.
Support
Strong support systems are vital to navigating the complexities of clinical trials; minimizing potential disruptions, keeping studies on track, and ultimately leading to better patient outcomes.
An IRT partner that provides a helpdesk team operating 24/7, 365 days a year, can be instrumental in resolving issues and concerns as they arise. Having an in-house helpdesk team who can access local language specialists ensures that sites are supported and their issues quickly addressed.
In-house specialists can also be valuable, offering insights from industry professionals with a wealth of knowledge in trial randomization and supply management. Look for an IRT partner which can provide technical experts with diverse experience – from eligibility and dosing calculations to medication management.
References
Requesting and checking references from IRT companies can offer valuable insights into the vendor’s performance, reliability, and customer support. This information, which should typically be provided by references such as previous clients, can be an important factor in compiling an initial shortlist, and your final choice.
Pay close attention to reports of overall system reliability, responsiveness to technical issues, and performance in handling study designs similar to your own.
Industry contacts
Have you leveraged your professional network to gain further insights about the IRT companies you are considering? Make use of industry contacts for an unfiltered perspective on IRT companies and their systems.
Information gathered from colleagues and peers – over the phone, by email, or at conferences and forums – can help to narrow down your options, and understand which vendors are currently preferred by trial investigators. You may learn about positive and negative experiences that can impact your decision.
User-friendly configurability
Is the IRT system user-friendly and intuitive with the ability to make routine protocol changes independent of the vendor?
It’s important that a system gives trial investigators and sponsors the flexibility and configurability to change study requirements, quickly adapting to evolving demands.
Expertise in master protocol designs
A comprehensive understanding of the entire clinical trial process should be seen as a prerequisite. Today, this demands expertise in complex master protocol designs which include several sub-studies and sub-groups
A vendor with this expertise can offer their input to the trial from setup through to implementation and management, providing an IRT system that is best suited to support study requirements and objectives.
Flexible cohort management
Having an IRT system that enables flexible cohort management will be important to maintaining study agility.
Flexibility can reduce complications associated with the management of participant cohorts, treatment arms, and study timelines. A system that offers robust cohort management capabilities enables sponsors to make informed decisions and adjustments, ultimately improving study outcomes.
Check for features such as real-time cohort tracking, dynamic allocation capabilities, and clear management of complex study arms.
As we’ve discussed, selecting the right IRT partner demands a thorough approach that involves a close examination of the vendor and its experience, system features and functionality, customer feedback, and suitability for your particular study. Taking the time to perform this due diligence can have a profound impact on the success of your clinical trial.
Sustainability
When considering your Request for Information for potential IRT partners, it’s important to gather details on sustainability. Can an IRT company demonstrate supply chain sustainability? And are their credentials rated or verified by an independent organization?
There has never been more of an onus on pharmaceutical companies to manage sustainability risks. The individual (such as a Sustainable Procurement manager) who, or team which, covers this side of your business should look closely at an IRT’s track record in sustainability, putting the spotlight on potential issues such as customized medicines and shorter product cycles.
In order to mitigate prevalent risks in today’s competitive landscape and meet the expectations of all stakeholders, the sustainability credentials of a potential partner must be scrutinized.
People
It’s not just the tech – synergy with the team who represent an IRT clinical trial company is an important consideration. Are you able to strike up a convivial and productive relationship with the individuals who make up the team? And are the people who will be working with you on a day-to-day basis equipped to offer the right guidance at the right time?
Price
Ultimately, the cheapest option may not be the most cost-effective. It’s important to thoroughly evaluate the pricing structure offered by an IRT vendor. You should factor in all associated costs, including implementation, ongoing support, and potential charges for protocol amendments, including the ability to build-in flexibility up-front to future-proof design.
