Used in more than 2,000 clinical trials and at over 130,000 sites around the world
Over the past several years, clinical trials have become increasingly intricate. Study sponsors now aim to satisfy multiple objectives within a single, more complex protocol. As the level of complexity grows, it’s imperative that the technology employed to capture this critical data keeps up. We have earned a reputation for providing a level of flexibility that is unmatched in the industry.
Available in multiple modalities, our market-leading solution for patient randomisation and trial supply management is the most configurable and customisable response technology available. From Phase I through to IV, simple designs to complex adaptive trials, IXRS® easily accommodate any permutation of study objectives.
IXRS® – Intuitive, sophisticated and reliable
IXRS® offers an intuitive and logical way to manage the key components of clinical trials including: screening, randomisation, dosing, drug supply/inventory management, patient tracking, clinical outcomes assessments and more – providing access to pertinent data points and actionable insight across studies and programs.
Our sophisticated supply management capabilities, allow our Project Managers to collaborate with sponsor teams to find the optimal balance of inventory to minimise supply costs and maximise successful patient resupply throughout your study.
Conducting many of the industry’s most complex studies
We are pioneers in adaptive and other dynamic randomisation techniques. To assist you in the design and implementation of dynamic randomisation and dose titration schemes, our in-house statisticians offer upfront consultancy during the planning phase. Their expertise will also be applied throughout your study’s life cycle to ensure its successful execution.
Numerous randomisation methodologies via IXRS®:
- Permuted block list approaches (central, simple through to complex stratification)
- Covariate adaptive (dynamic) randomisation methodologies, including:
- Pocock and Simon minimisation with biased-coin assignment
- Dynamic hierarchical methodologies
- Custom methodologies
- Adaptive trial designs
Adaptive trial designs
Well-designed adaptive trials result in lower drug development costs, reduced timings, faster decisions and improved patient safety. IXRS® and eCOA tools capture safety and efficacy data and make it viewable in real-time – providing sponsors with the information they need, when they need it quickly.
We have implemented more than 100 adaptive studies and established a reputation as a market leader in adaptive trial designs including:
- Fixed interim designs
- Bayesian response adaptive algorithms
All of your data, where you need it to be
Today’s trial managers need instant access to accurate data in order to make informed decisions that can impact timelines and costs. Empowering users with real-time reporting means sponsors and sites can quickly address compliance issues, adverse events, and supply and patient needs.
Interactive Reporting™ (AIR)
AIR is a powerful, user-friendly reporting system which helps clinicians and supply management professionals maximise the value of their clinical data. With its standard and custom dashboards, AIR can create client view alerts, trial metrics, key performance indicators (KPIs) and other clinical trial-related information available at a glance. Generating key study data from the IXRS® database, AIR provides faster access for up-to-date clinical trial information.
With AIR you also have the ability to view your data in real- time and drill down, sort, filter, analyse and share information quickly with other team members. You can easily create graphs, charts and tables to display information, as well as, custom reports that can be saved in The Cloud for future use.
AIR’s online help tool features
- An easy-to-use menu view of all reports contained in AIR
- A quick index (content) search by keywords contained in the report
- A keyword search for all reports containing the query
AIR reports can be accessed through multiple operating systems, including Apple Safari, Blackberry, Google Chrome, Internet Explorer and Firefox. Reports can also be exported to a variety of formats.
Cost-effective and highly efficient strategies
Our Data Services team is dedicated to creating strategies that can accommodate your needs quickly and methodically. They have extensive experience working with all formats necessary for data transfer and integrating with central laboratory systems, Clinical Trial Management Systems (CTMS), Drug Supply Management Systems (DSMS), leading electronic data capture (EDC) software and other data analysis and management systems.
Through consultancy, our team works to identify relevant interactive web / voice response data to integrate with any target system. We support numerous file formats, transmission methods, and frequency needs. Custom decodes of data are also supported, to allow for reduced coding and the easier processing of data.
As partners, we take pride in finding solutions for the various challenges you may face. With our vast experience, we can also advise you on implementation practices common to your industry peers and help you implement common software technologies – improving your overall operational readiness and ease of adoption.
We are proud members of CDISC, which establishes standards for the integration of clinical trial data from all sources.