Monthly Archives

October 2018

Register to Participate in the CluePoints Data Quality Challenge

Are you struggling with how to assess the true value of improving data quality and integrity through Risk-Based Monitoring (RBM)?

Register to participate in the CluePoints Data Quality Challenge to find out first-hand how the ICH E6(R2) has given the industry, not only the a chance to become much more resource efficient while increasing data quality, but to realise huge cost avoidance benefits too.

In letting CluePoints conduct this Data Quality challenge(at no expense to you) to prove that it will find critical risk signals and identify them early enough for you to take appropriate action, we will give you:

  • The ultimate insurance policy for your clinical study. Periodic Data Surveillance using CluePoints gives you the peace of mind that the software will leave no stone unturned in interrogating ALL of your clinical and operational data to isolate areas of risk.
  • The answer you have been looking for to ensure compliance with the new ICH E6 R2 guidance from a technology perspective and, via our Implementation Experts, the support you need to get the People and Process elements aligned too.
  • An assessment of the resulting Cost Avoidance opportunity that allows you to prove to Executive Management both the power and the cost benefit of employing a risk-based approach to study execution in the future. We will work with you to identify how this approach would have saved time and money and the magnitude of those efficiencies.

You can access more information, along with the Data Quality Challenge terms & conditions here.

Ready to find the critical risk signals in your clinical data? Click the registration button below and we’ll get in touch with you ASAP.

Register for the Challenge

Announcing the CluePoints Data Quality Challenge

Are you struggling with how to assess the true value of improving data quality and integrity through Risk-Based Monitoring (RBM)?

Now is your chance to find out first-hand how ICH E6 R2 has given the industry, not only the chance to become much more resource efficient while increasing data quality, but to realise huge cost avoidance benefits too.

If your organization has a completed study that was associated with significant findings related to misconduct and/or data quality, then we want to hear from you.

Provide us the final dataset for the study at database lock (with the issues residing somewhere within the data provided) and CluePoints will do two things (at no expense to you):

  1. The statistical engine that lies at the heart of CluePoints will interrogate that entire dataset and identify the risk signals that uncover the critical issue(s) that you eventually found.
  2. We will then create interim snapshots of the data at 10% accrual, 20% accrual, 30% and so on in order to demonstrate exactly when we would have identified the underlying risk. This means that you will see when you would have been able to take corrective action to mitigate the issue(s).

In letting CluePoints conduct this Data Quality challenge(at no expense to you) to prove that it will find critical risk signals and identify them early enough for you to take appropriate action, we will give you:

  • The ultimate insurance policy for your clinical study. Periodic Data Surveillance using CluePoints gives you the peace of mind that the software will leave no stone unturned in interrogating ALL your clinical and operational data to isolate areas of risk.
  • The answer you have been looking for to ensure compliance with the new ICH E6 R2 guidance from a technology perspective and, via our Implementation Experts, the support you need to get the People and Process elements aligned too.
  • An assessment of the resulting Cost Avoidance opportunity that allows you to prove to Executive Management both the power and the cost benefit of employing a risk-based approach to study execution in the future. We will work with you to identify how this approach would have saved time and money and the magnitude of those efficiencies.
  • This challenge will give us the use cases we need to prove the value seen by our customers to date. We would insist on the ability to anonymise your details entirely (if necessary) in order to produce a case study that will be used to promote how CluePoints will drive these tangible benefits.
  • An opportunity to collaborate with you in this kind of ‘proof of concept’ arrangement so that we can establish a lasting partnership between our organizations.

If you are interested in taking us up on this Data Quality Challenge, then please click the button below to submit your details and we will get back to you right away.

We won’t be able to analyse every study that is offered up so please make sure you get your study ideas to us as soon as possible.

Please submit all candidate studies by Friday November 30thand we will decide by end of the following week. We look forward to hearing from you. Good luck!

Register for the Challenge

The CluePoints & HighPoint Solutions Risk-Based Monitoring Roadshow Recap

The other week, CluePoints in conjunction with HighPoint Solutions delivered 3 European Roadshows in Basel, Copenhagen and Cambridge, focusing on practical, case-based methods for addressing the challenges of Risk-based Monitoring (RBM). As well as hearing from key opinion leaders in the industry, each event was an ideal forum for attendees to share thoughts and experiences. The events were attended by over 90 Bio-Pharmaceutical Sponsors and Contract Research Organisations that provided a diverse and stimulating dynamic, especially given the ICH E6 (R2) content that targets CRO oversight by sponsors.

A number of themes were recurring across the events and made for lively discussion. The first was a simple but important concept in that the audiences didn’t feel that all industry stakeholders properly understood why they were needing to implement Risk-Based Monitoring within their own businesses. There was a feeling that beliefs existed within the industry, that this was a ‘mandated’ activity driven by a change in regulatory thinking rather than a desire to maximise the quality of clinical data. A quick poll of the audience showed that in some organisations, the RBM activities were attached firmly to the concept of quality, while in others it was regulatory change and, in some cases, even being driven by the need to try to lower costs. It’s also worth noting that in terms of attendees, about a quarter had active RBM initiatives within their own businesses. There was then a discussion on assessing organisational readiness to implement RBM and where it was important to focus.

One of the dangers that was discussed following from the above was without proper understanding of the reasons for RBM, coupled with looseness of implementation, could lead to reverting to old practices when issues were detected on a clinical trial. A number of attendees had seen a reversion to 100% SDV as a monitoring activity despite trials being initiated with a risk-based approach to quality management and monitoring. There was also feedback that trials had been initiated with the implementation of a RACT to begin with, but then operational practices had remained consistent with previous trials and ways of working.

A major discussion area was the evolution of roles and responsibilities to support RBM trials, especially the evolution of the ‘Data Scientist’ role that supplements the data surveillance activities of monitors and data managers. The discussion continued that this role typically evolves from staff who have historically been data managers, although there is still diversity within the industry. There was also comment that some organisations had restructured data management and monitoring into a single entity, reiterating the importance of these roles to the implementation of risk-based quality management in general.

Some attendees described their challenges in the development and application of Quality Tolerance Limits (QLTs). These pre-defined limits are intended to help identify systemic problems that may influence trial results or patient safety.  The few sponsors who have started the effort are encountering challenges in defining, tracking, and keeping these limits up to date.   CluePoints and HighPoint Solutions are rolling out software features and processes to address this evolving area of the risk-based approach.

The application of artificial intelligence and machine learning within the clinical trials process to guide disparate stakeholders through the planning and execution of clinical trials through targeted risk management is both a current capability and evolving trend for CluePoints. This helps support the industry as it moves to implement risk-based everything (RBX), a holistic risk-based approach to quality management within its operations.

All 3 events were excellent opportunities to learn and share experiences that elicited frank and open debate from all. Given the success of these last week, CluePoints is looking forward to facilitating further events in the future. If you’d be interested in attending one of our future events, please feel free to send an email to contact@cluepoints.com to register your interest and help us identify suitable locations for future events.

 

CluePoints Strengthens Senior Team with Two Key Appointments

Wayne, PA – October 02, 2018: CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has announced the appointment of two industry thought-leaders to its senior team, as it continues its impressive global growth throughout North America, Europe and Asia Pacific. Richard Davies joins as VP, Solutions Expert, and Suzanne Lukac as Senior Account Director.

Suzanne Lukac joins the company from Merck, where she was previously Director for Clinical Operations, Global RBM Implementation, with over 20 years’ proven practical experience in the pharmaceutical industry and brings unrivalled hands-on experience in the tactical implementation of RBM to her new role, along with a thorough understanding of the implementation process and beyond.

Based in the US, Suzanne will take on a global role with responsibility for managing both enterprise-level clients and individual study engagements, taking primary accountability for ensuring client success, and working with customers to lay the foundations for a successful RBM implementation. Suzanne will also lead the development and delivery of consultative services covering RBM methodology as well as working closely with the product team advising on enhancements to CluePoints’ RBM platform.

Previously at OmniComm Systems as Executive Director of Business Solutions, Richard brings a wealth of technical expertise to his new role, with over 20 years’ experience in the industry. Richard has worked with electronic data capture technology since its introduction and as such, has a real in-depth understanding of technology and how it can be utilised within clinical trials. Based in Europe but with a global role, Richard will be the go-to expert on CluePoints’ RBM technology. He will be responsible for supporting the product development and adoption processes for CluePoints’ solutions to worldwide pharmaceutical and biotechnology companies and CROs, and will act as a commercial product expert for all elements of the software product.

Commenting on these appointments, Francois Torche, CEO at CluePoints comments, “Richard and Suzanne are recognized industry experts. As we continue with our ambitious growth plans, their wealth of knowledge will be fundamental to our clients’ success and will drive thought-leadership on behalf of CluePoints. I am delighted that Suzanne and Richard are joining the team as subject matter experts in their respective functional areas.”

Having already established itself as the leading provider of RBM technology and are finalist’s in the 2018 Scrip Awards for the Best Technological Development in Clinical Trials – Tech Sponsor-Focused Category, this latest announcement cements CluePoints’ ambitious plans to continue its global expansion. For further information on CluePoints’ solutions, please visit www.cluepoints.com.

About CluePoints

CluePoints® is a Risk-Based Monitoring and Central Statistical Monitoring solution that has been designed and perfected over the last 15 years. It employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the ICH, FDA, and EMA, CluePoints® is deployed to support traditional on-site monitoring, medical review and to drive a Risk-Based Monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.

Media contact

Patrick Hughes – Chief Commercial Officer, CluePoints

Patrick.Hughes@CluePoints.com

+44 (0) 7703 532 749