As a complex, inherited disease, cystic fibrosis impacts the respiratory, gastrointestinal and reproductive systems. Many clinical trials are examining therapies that target this rare disease from different therapeutic angles, such as restoring function to a faulty protein, reducing inflammation, clearing mucus buildup, addressing gastrointestinal manifestations or fighting cystic fibrosis-related infections.Continue reading
Clinical research associates (CRAs) need immediate access to relevant and accurate site performance metrics, but information is often isolated within multiple databases and spread across different tracking systems. To deliver key site performance data to CRAs via mobile and web applications – quickly and conveniently – Covance has created a specialized clinical analytics suite of products, Covance Xcellerate® Informatics. This powerful solution integrates data from all sources and allows a CRA to gain a clear and concise view of all clinical trial data, in one place, for all the sites that a CRA is monitoring.
Most sponsors are well aware of the recent revision (R2) of ICH GCP E6, which outlines recommendations to unify standards across the EU, Japan and the U.S. with defined requirements for sponsors regarding the role of monitoring and risk management, there are many factors to consider for a successful implementation.
This article discusses a variety of challenges sponsors may face when preparing to address these recommendations and also examines opportunities to drive greater efficiencies in today’s complex trial ecosystem.
Addressing varying levels of adoption
According to the latest revision, sponsors are tasked with a requirement to employ an adaptable quality management system and are expected to maintain oversight of CROs. But with various tracking systems, vendor logs, CTMS and monitoring platforms, seeing the complete picture can be an overwhelming, error-prone effort. Continue reading
Despite expert design and thoughtful planning, all studies will encounter risks and issues. How well these risks and issues are managed directly correlates to how well a study is run. But tracking issues and their mitigating actions can be a cumbersome and inefficient process.
To gather insights about how to solve this ongoing problem, we met with study teams, representatives from multiple functional areas, oversight teams and clients. See how these critical insights were used to design a flexible system centered on operational and quality excellence. Continue reading
What issues do patients cite as barriers to clinical study participation? How far are they willing to travel to participate in a study and how much more willing are they to participate knowing that their physician is aware of the study?
We asked these questions – and more – to group of 135,000 people who opted in to the LabCorp database to receive more information about Covance clinical studies. More than 2,500 responded to our survey, providing our team with unique insights to better understand the patient mindset and design more effective recruitment strategies.
Next, to see if our colleagues in the drug development industry could surmise our participants’ aggregate answers from this survey, we delivered a short pop quiz. Any attendees who stopped by our booth at the 2017 Drug Information Association annual meeting (DIA), had a chance to take the quiz and see how they fared. Continue reading
Today’s clinical trials have become more complex and expensive, pressuring pharmaceutical companies to further improve their clinical trial operations. Clinical trial data management is one area where both sponsors and contract research organizations (CROs) can uncover new efficiencies, increase cost-saving measures and better meet diverse operational reporting needs across the clinical development cycle.
In this blog we begin to examine the current issues with traditional electronic data capture systems and other current “big data” approaches that attempt to address complex operational reporting needs in this historically stagnant and underserved area. We also discuss the use of two distinct data repositories – an operational data warehouse and a clinical data warehouse – the Xcellerate® Clinical Data Hub as part of a new data model through the Xcellerate Informatics Suite to provide a significant technological advance in clinical trial operations. Continue reading
Covance is excited to announce that Xcellerate® Medical Review has been named a finalist in the Clinical & Research Excellence (CARE) Awards. As a finalist in the Best Sponsor-Focused Technological Development category, Xcellerate Medical Review is being recognized for its modern approach to improving the clinical trial process. The CARE Awards recognize excellence across the global clinical research enterprise.
The Xcellerate Medical Review informatics product provides a critical function to study sponsors to safeguard subject safety, increase the robustness and quality of clinical trial execution, improve the reliability of investigational data and ensure adherence to ethical standards. Xcellerate Medical Review is a part of the larger award-winning Xcellerate Clinical Trial Optimization® suite, a comprehensive informatics solution that can meaningfully reduce the cost, time, complexity and risk of drug development. Continue reading
Covance is proud to announce that Xcellerate® Trial Design has been selected as the winner of the Fierce Innovation Awards: Life Sciences Edition in the Data Analytics/Business Intelligence category. The Fierce Innovation Awards: Life Sciences Edition recognizes outstanding innovations that are driving improvements and transforming the life sciences industry. Xcellerate Trial Design was recognized for its innovative approach to improving site selection, forecasting resource demand and optimizing of clinical trial design. Continue reading
Over the last 10 years, clinical trials have changed substantially in response to increasing globalization and study complexity, along with new technological capabilities and industry guidelines,7. With these noticeable transformations, sponsors are increasingly revisiting their monitoring methods to uncover new efficiencies and develop more robust risk management processes that can enhance ongoing patient safety and data quality.
At the forefront of this movement is risk-based monitoring (RBM) – a broad term for a variety of clinical monitoring methods that combine people, process and technology, enabling project teams and Clinical Research Associates (CRAs) to focus on the most important risks in clinical trials.
As any drug developer knows, clinical trials generate a lot of raw and electronic data from multiple sources. Yet tracking progress and reviewing results from each separate database can be cumbersome in traditional environments. This “rear-view” mirror approach to monitoring doesn’t support preventative planning to mitigate future risks and can account for 20-30% of a trial’s costs.
Recognizing the opportunity increase efficiency and deliver information faster, Covance created Xcellerate® Monitoring, a platform that integrates clinical trial data to help sponsors proactively decrease the inherent risks associated with clinical trials.
At a recent clinical seminar in China, Dimitris Agrafiotis, PhD, Vice President, Chief Data Officer discussed how Xcellerate Monitoring tracks quality, patient safety and protocol compliance in clinical trials. Continue reading