There’s an estimated – and astounding – 200% overage problem that occurs annually in the global clinical trial industry.Read More
At Cenduit, we’re committed to making sure our customers get the most from their investment in IRT (IVRS/IWRS). Here, we’ve compiled a mix of resources, from Quickcasts to White Papers, covering numerous topics, from Drug Accountability to Patient Engagement. Still have questions? Contact us anytime for immediate answers.
Andrew Rohrbaugh, Cenduit’s Director of Client Delivery and Susan Mills, Associate Director of Research and Clinical Trials Operations at Washington University School of Medicine discuss patient-centric IRT delivery in a complex Alzheimer’s research study.Read More
For the last three years, Cenduit has successfully partnered with a large CRO and a major academic medical institute on an early onset Alzheimer’s Disease study. Deploying an IRT solution for a clinical trial conducted by an academic medical center comes with several unique challenges.Read More
Meeting the challenges of clinical supply management demands smart thinking and a clear understanding of the issues. I start with the premise that IRT should be free for most studies. Now, I’m not saying our customers should not pay, I’m just saying that it should save you enough money over the course of the study to pay for itself.
One trillion dollars. That's the revenue of pharma in 2015. Pharma is very R&D intensive, so on average about 15% of revenue is invested in R&D. That means 150 billion invested in R&D alone. And almost two thirds of that goes into clinical trials, or 90 billion dollars! About one third of that goes into clinical supply spending – 30 billion dollars are invested every year!Read More
Today most Interactive Response Technology (IRT) vendors have developed modern, configurable systems and much has been written about Agile development and delivery methodology as well as faster builds that improve system quality, reduce risk and simplify validation requirements. These system developments over the past several years have certainly brought many benefits to Randomization and Trial Supply Management (RTSM) delivered on IRT. Interestingly, though, while some eClinical technologies, such as Electronic Data Capture (EDC), are readily brought in house by biopharma companies and Contract Research Organizations (CROs), IRT is rarely “tech transferred” by comparison. Instead pharma companies generally seek IRT vendor relationships to ensure high quality builds that meet their needs and avoid the potential pitfalls associated with RTSM. Download our paper to learn about the many areas where an IRT specialist can add great value to a study.Read More
IRT is changing rapidly. Your needs and the solutions you employ to keep your studies on track need to do more than just keep up–they need to keep you out in front. Cenduit is committed to cutting edge IRT solutions, helping you meet all your timelines with fully integrated systems to monitor your study and retain patients throughout the life of the study. Download our paper to learn what questions you should be asking to get the best integration capabilities for your study.Read More
An engaged patient is one that's less likely to become lost to follow up. And the more patients that stay in your study, the lower your overall costs, the better your data integrity, and the better the experience is for patients, sites, and your clinical team. Download our paper to learn more reasons your next study should integrate patient engagement into your IRT.Read More
It is time for our industry to move forward to bring drug accountability into the 21st century. The proven benefits include improved patient safety, enhanced RBM and quality, reduced site burden, reduced risk of inspection and audit findings as well as the ability to close out studies more quickly, thereby cutting costs. Additionally, since DARM functionality is already fully integrated into solutions that sites and sponsors are already using via the IRT system, the deployment and set-up efforts are minimal. Is your organization ready to benefit from electronic drug accountability?Read More
IRT is changing rapidly. Your needs and the solutions you employ to keep your studies on track need to do more than just keep up - they need to keep you out in front. Areas such as drug accountability & returns, forecasting, patient retention, integration and automated monitoring. All keys to the success of your trials . Learn more about each in this helpful tool.Read More
Accurate forecasting of clinical supplies has become increasingly important in the past several years as planning the amount of study drug and other materials required to complete a trial has grown in complexity. Key drivers adding to this complexity include increased numbers of trials, reduced start-up timelines, patient recruitment challenges, globalization leading to more distant clinical sites and a variety of regulatory requirements, and escalating costs for investigational drugs and comparators.Read More
Maintaining the study blind is a critical part of maintaining the integrity and validity of any clinical trial. Experienced IRT providers have a variety of SOPs, system controls and well-trained members of staff to ensure that all blinded reports, data transfers and study documentation and communications are sanitized and free of any sorting or data that could even partially reveal the study medications in inventory or those assigned to patients.Read More
The key goals of effective trial supply management are to ensure that every patient gets their medication on time while minimizing any waste, which requires balancing a large number of factors. Robust trial supply management can greatly cut costs by reducing waste, minimizing the number of shipments, making efficient use of older supplies before they expire and by automating the entire resupply process, thereby eliminating costly human errors. Learn how a solid IRT system can model and automate all relevant factors right out of the box in this comprehensive white paper.Read More
Cardio devices. Spine breakthroughs. Knee advancements. Each medical device is highly unique and the same is true of every device trial. Our insight into different regulatory implications, combined with our IRT expertise and innovation, can take your trial to the next level. Our IRT specialists can decipher, anticipate, and translate the many nuances of medical device trials.Read More
Drug accountability is crucial for monitoring patient compliance and ensuring clinical trial data integrity. Cenduit uses the power of Web-based, real-time technology to improve, streamline, and ease the drug accountability process. We have extensive experience implementing drug return, reconciliation, and accountability into the IRT system’s functionality. IRT (IVRS/ IWRS) is the ideal tool for this purpose as it already tracks each medication dispensing unit by warehouse, depot, and site location, as well as by batch, bulk lot, packaging step, label group, and patient allocation.
An intuitive, proactive patient engagement strategy can improve your trial’s patient sustainability, and reduce the costs associated with having to re-recruit new patients into the study. Download this guide to discover a new approach to patient retention and compliance that will maintain the statistical integrity of your clinical trial data and reduce burden on investigator sites.Read More
IRT (IWR/IVR) integrations have gone from a nice-to-have to a must have. From simple IRT data transfers to EDC, to complex deep integrations with sponsor supply chain management systems, Cenduit IntegralSM has technology and experts to simplify the entire user experience. Download this guide to learn more about you can achieve seamless eClinical integration.Read More
Randomized, double-blind clinical trials are the gold standard for adequate and well-controlled studies in modern times. In this white paper, you'll learn how important randomization is, and how an effective randomization plan built into an IRT system forms the basis of a bias-free, well-controlled trial.Read More
A leading biotechnology firm with a reputation for delivering quality solutions was tasked with conducting a groundbreaking oncology trial. Due to the critical nature of the trial, they had high expectations and demanded exceptional results. After originally working with another IRT (IVRS/IWRS) vendor who failed to meet their needs, they came to Cenduit to bring their trial back on track. This case study discusses how Cenduit came to the rescue and went above and beyond expectations by creating a completely seamless IRT vendor transition.Read More
Stefan Duerr, Cenduit’s Associate Director, Project Management, discusses what needs to be considered when defining your clinical trial’s drug supply strategy in an IRT system.Read More
The increase in federal audits and the growing federal regulations has made drug accountability management a major challenge. A failed federal audit leads to costly trial delays, and possibly non-approval or criminal liability. Electronic drug accountability managed through an IRT system can ensure compliance, reduce inefficiencies, preserve data integrity and increase patient safety.
This white paper examines how electronic drug accountability managed through an IRT system:
- Improves protocol compliance
- Reduces clinical trial inefficiences
- Preserves study data integrity
- Increases patient safety
The average cost of a patient lost to follow-up is $5,000. Download this paper to learn how to incorporate patient reminders into your protocol to reduce cost and resource wastage associated with patient noncompliance and early withdrawal.Read More
Patient recruitment is the #1 cost to any clinical trial, with patient retention following at a close #2. This infographic visually depicts how you can prevent the unnecessary costs of patient dropout and noncompliance with a patient reminders program.Read More
As the only IRT specialist in the world, we're in a unique position to better understand the IRT needs of sponsors during the RFP process. The following checklist will be helpful in pricing an IRT solution specific to the needs of your clinical trial.Read More
We want your drug to succeed as much as you do, and we will go above and beyond to help you bring innovative therapies to market. This checklist is specifically designed to help small- and mid-size pharmaceutical and biotech companies feel completely confident with the selection of their IRT (IVRS/IWRS) partner.Read More
The objective of this guide is to help you navigate the relationship with your current IRT (IVR/IWR) vendor and determine whether or not transitioning to a new vendor will help you manage your clinical trial more efficiently. The guide concludes with a step-by-step process that will help you transition from one vendor to another smoothly and confidently.Read More
A panel of experts behind the design of Cenduit's new IRT user interface (UI) talk about the important role user experience played in designing the interface. The panel includes Chris Dailey, Cenduit's Global Head of Technology, as well as two special guests from the design and development firm that helped us bring the new UI to life: Dante Passera, Director of User Experience and Lucas Brauer, UX Project Lead at Smashing Boxes.Read More
Jesse Jones and Nicole McPherson in Quality Assurance and Sales talk about their experience at the Drug Information Association (DIA) 2014 meeting in San Diego. From shoe fashion advice to tips on how to win contests at neighboring booths, this quickcast is packed full of fun trade show tidbits.Read More
Jim Graffam, Cenduit’s VP of Quality Assurance, provides insights into the world of auditing and how to use technology to streamline the auditing process and improve the auditor experience.Read More
Selecting an IRT vendor is an important investment for your clinical trial. Download this free guide to take control of your trial and inform your decision throughout the vendor selection process.
You will learn how to:
- Reduce workload at the investigator site
- Increase protocol compliance
- Increase patient engagement & retention
Andrew Rohrbaugh, Associate Director of Project Management, describes three "worst case" scenarios he has encountered during his 6 years as an IRT specialist and how we were able to help sponsors avoid potential clinical trial disasters through a proactive approach to IRT project management.Read More
From finding the right balance between drug overage and outage, to ensuring every patient receives the right medication when they need it, managing clinical trial supply is no easy task. This 2-page brochure explains how we address the unique challenges of the clinical trial supply manager.Read More
From the continued acceleration of patient engagement to the growth of tools for evidence-based medicine, the clinical trials industry has changed significantly over the past 12 months. As 2015 draws to a close, we’re reflecting on the top 10 trends across interactive response technologies (IRT) and clinical trials from the year:Read More
What is the difference between a medical device trial and a drug trial?
On a very basic level, there are some obvious differences between drug trials and medical device trials. The terminology is different (IDE vs. INC), the protocol varies, and there are different regulatory implications to consider. An understanding of these differences is crucial, but insight and innovation to address them can take your trial to the next level.Read More
What is drug accountability?
In a clinical trial, drug accountability is essentially tracking the whereabouts of the drug. This includes storage, shipping to sites and depots, dispensing and administering to patients, as well as returns and destruction. The accountability process is a requirement, and investigator sites that do not manage this process or manage it poorly are considered noncompliant and subject to fail FDA inspections. In addition, poor drug accountability can have an impact on patient safety, as insufficient records may cause site staff to dispense the wrong dose or the wrong drug to the patient.Read More
Our research suggests many patients simply do not follow the correct dosing regimen in a clinical trial. This article explores the medication adherence and compliance challenges study teams encounter when conducting a clinical trial.Read More
On September 11, 2014, Cenduit announced the launch of a new user interface for its flagship IRT system and I wanted to take the opportunity to reflect on why a redesign was necessary and how we determined what should go into the new design. Change, while inevitable, isn’t always welcome, but we hope you’ll agree that we’ve struck a good balance between what is possible and what is acceptable.
To some degree, the ‘why’ of the redesign is driven by a number of related trends.Read More
Choosing an IRT (also known as Interactive Voice and Web Response) system is often one of the last decisions made by the trial team. Understandable. They’re so busy with getting the trial up and running on time, that discussing IRT functionality and implementation is the last thing on their minds.
But your IRT is a vital part of your trial and should be considered more closely.Read More