Monthly Archives

August 2016

CluePoints Announces Free Risk-Based Monitoring Strategy Review

We’re thrilled to announce that CluePoints is now offering a complimentary Risk-Based Monitoring strategy Check-up and Risk Management review, aimed at helping sponsors and CROs accelerate their path to successful Risk-Based Monitoring adoption.

Steve Young, Senior Vice President of US Operations for CluePoints, will leverage his twenty plus years of industry experience to help companies identify how they can best implement a Risk-Based Monitoring strategy that meets ICH E6 Rev 2, FDA and EMA recommendations.

The resulting feedback will include a gap analysis that reinforces what is working well and recommendations on opportunities for further optimization. ICH E6 Rev 2 – which is due to come into effect before the end of this year, insists that sponsors have a documented plan to identify and mitigate operational risks – Steve will address this critical item as a part of the overall Risk-Based Monitoring review.

Steve’s credentials in the area of Risk-Based Monitoring are unrivaled, with experience both sponsor and vendor side in leading initiatives with Johnson & Johnson, Medidata, and TransCelerate defining successful Risk-Based Monitoring strategies.

This complimentary review is simple and pain-free and is an ideal opportunity to discuss your strategy, plans and current situation with a thought leader who has been responsible for advising sponsors on what’s required to deliver Risk-Based Monitoring and Risk Management success for organizations.

Send an email to to schedule your complimentary review!

Risk-Based Monitoring Insights from the Industry: Angie Maurer

Part Seven

In the latest of our eight-part ‘Insights from the Industry’ series, we caught up with Angie Maurer, Co-Founder & CEO at Zynapsys. Here’s what she had to share with us.

When it comes to the practical implementation of Risk-Based Monitoring, where do you observe differences in current best Risk-Based Monitoring practices between companies and CROs of different size?

There is currently no standard way of implementing RBM across the industry. In my opinion, the first thing that any company seeking to implement this new approach should do is undertake an organizational assessment. They should consider available resources and budget, as well as examine what the company needs are, including its vision and goals etc, and importantly, its expectations of the RBM program.

With any RBM implementation, it is important that organizations are realistic about what is achievable and feasible, and take that into consideration during the program design phase. So are you implementing a simple RBM function, or are you developing a more holistic program which takes into consideration other departments and functional areas that will be impacted by RBM.

Looking at where the industry is now, I think a lot of companies are ‘dipping their toes in the water.’ We have seen much more prevalent implementation of RBM in the large pharma space, particularly by the top two, mainly because there is an availability of funding. We are also seeing some sponsors considering how they can embed RBM within their organizations as a standard capability, rather than as an isolated practice in one off trials, which is promising.

We have spent a lot of time with the smaller pharma and biotech companies where the focus tends to be on how they can actually go about this within an organization of their size. As small pharma companies typically outsource much of their clinical trial management to CROs, there is a question over how they should manage the adoption of RBM. Should they just outsource it? Or should they take certain components on? For example, the central monitoring. In my opinion, much of it comes down to whether they are going to get anything out of it from an efficiency or value perspective. Or are they so small that it’s not worth the transition because of the cost implications of transitioning? Are they going to get an outcome from it over the next couple of years to make it worth it? This is an important consideration for small companies that simply don’t have the same financial support as the larger pharma organizations.

What is apparent to organizations of all sizes is that this is a big change, both in terms of culture and systems, as well as technology. In order to drive RBM adoption efficiently, accurately and compliantly, organizations must make sure the changes are communicated to all the relevant people in the business process, including any third party partners. From a technology view point, it’s about systems being able to meet the needs of all users; giving them access to the information they need, when and how they need it, so they have the knowledge to act accordingly.

How are the regulatory authorities likely to respond to the widespread adoption of Risk-Based Monitoring – are they ready for it and why?

I think by releasing the guidance they have to be, but I think there will be a transition period in which the authorities allow the industry to get up to standard. How long that period is, I’m not sure. I think it will be a case of waiting and seeing how this pans out as more and more organizations adopt this approach.

The changes soon to come into force via the ICH (E6) Addendum very much focus on improving quality, but in my view, there will need to be some flexibility on timings for smaller companies that don’t necessarily have the budget or resources to implement RBM as easily or quickly as the larger pharmaceutical organizations.

How do you think that the multitude of electronic systems are going to co-exist as Risk-Based Monitoring takes off? Will other systems become obsolete or will they need to evolve too?

I think we are likely to see the evolution and integration of current systems to incorporate RBM capabilities, as well as the introduction of new technologies.
In my view, our industry has many companies that have spent years developing deep understanding of their markets and customers, and creating innovative, targeted, solutions. For that reason, I don’t think one single company will be able to provide the best quality solution in all the areas needed within one product, and as such, there is a real opportunity for collaboration. By working together in partnership, companies specializing in different areas, for example EDC and monitoring, can create powerful new solutions for the industry.

Much of the early work in Risk-Based Monitoring has a focus on relatively simple KRIs and traffic-light dashboards which are easy to understand. There is a growing need to complement this approach with a more sophisticated and comprehensive analysis known as Central Statistical Monitoring (CSM).

How are companies likely going to adopt these complementary approaches to ensure data accuracy and integrity?

I think companies will be open to CSM because without the support of technology, we can only do so much in terms of the review and analysis of data. These systems deliver not only more transparent and efficient data but the sophisticated technology ensures data is also much more robust, so I think we will definitely see an increase in adoption.

That said, I think budget will be an influence here. I would like to see technology providers develop a flexible platform that will allow even small start-up companies to afford and implement these powerful tools.

Discuss the complexity of defining subjective thresholds using Key Risk Indicators KRIs rather than (or in addition to) the objectivity of comparing one site against the others

I think this comes down to the individual needs of an organization. I personally don’t think you can do one without the other, and that study teams should combine both approaches. What’s important when reviewing risk for a study program is being able to find a way to take subjective information and make it measurable, and easy for study teams to understand.

What are your thoughts on the ICH (E6) Addendum, how to implement the parts outlined in the guidelines practically for the respective area (EDC, Risk-Based Monitoring, etc.) and how the changes could impact current practices?

In terms of practical implementation, the first thing companies would need to utilize is a quality by design/RACT type of tool. Designing the study protocol is critical and implementing this type of tool will ensure the bare minimum of the guidelines are met. Second is the implementation of CSM, and third is the use of a risk tracking system. A risk tracking tool is a way to monitor, manage and rank all of the risks for a study, so by supporting risk control and mitigation, these tools help study teams directly address a large part of section 5.0 of the ICH (E6) Addendum.

A quality management plan, which details how the study team is going to ensure quality throughout the program and summarizes all the key information, is the next step. Organizations can then provide this document as evidence to the regulators during the inspection. Finally, it is crucial for teams to continue with the traditional, ongoing risk review activities, typical of most current trials. By holding regular team meetings, where any issues are discussed and minuted, study teams can ensure risks are highlighted and managed on a regular basis.
In my experience, our industry is very reactive. Everyone is so busy with day-to-day activity, that there is little time or head space take a step back and plan ahead, meaning we are often not as proactive as we could be. With this in mind, I think the ICH (E6) Addendum will really make companies stop and think, and force them to be more proactive in the management of their programs. This will come into play from the very beginning of trials, as companies start to assess risks when they are drafting their protocols, meaning the number of iterations to the program should decrease because of the pro-activeness of planning ahead.

CluePoints Appoints Steve Young as Senior Vice President of US Operations

16 August, 2016
Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has appointed Steve Young as Senior Vice President of its US Operations. The appointment marks a key strategic move for the company in optimizing its operational performance, customer support and service delivery across North America.
Young will oversee all US sponsor deliverables including software implementation, professional services, and RBM process consultancy. He will also take responsibility for customer success planning and execution, including working closely with clients to further enhance the use of CluePoints’ Central Statistical Monitoring platform within their organizations.

With a career in clinical research spanning more than 20 years, Young brings unrivaled specialist knowledge to CluePoints, having worked on the sponsor side for J&J, Centocor, Astra-Merck and most recently as Senior Director of Transformation Services for OmniComm Systems, where he was responsible for overseeing and delivering advanced RBM services for clients.
“We are delighted to welcome Steve Young to our team,” said CluePoints’ CEO, Franҫois Torche. “With more and more CROs and BioPharma sponsors embarking on a knowledge transfer process to enable them to be self-sufficient in using RBM software, we are continuously looking to bring the highest level of expertise to our team to ensure our clients have the support and guidance they need during this process.”

“Steve’s experience and reputation within the sector make him the ideal person for this newly established position within CluePoints, and having already worked closely with Steve for a number of years in his previous role, I am confident that he will achieve great success as part of the CluePoints team. Many sponsors look to CluePoints, not only to provide them with THE enabling technology for Risk-Based Monitoring, but also to advise how they should change their internal process to get the best out of their technology choice. We now have the perfect industry Thought Leader to enhance that consultative discussion.”
Commenting on his appointment, Steve Young said: “CluePoints has a fantastic reputation and is at the forefront of RBM, helping some of the most recognized names in the industry to integrate the approach seamlessly into their workflow. I’m very much looking forward to being part of the team and helping CluePoints continue its impressive journey.”
For further information on CluePoints’ solutions, please visit

About CluePoints

CluePoints® is a Central Statistical Monitoring solution that has been designed and perfected over the last 10 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 FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring 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.

CluePoints CEO, François Torche, Honored in PharmaVOICE 100

1 August 2016
Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) solutions for clinical trials, has today announced that its CEO, François Torche, has been selected by PharmaVOICE as one of the top 100 most influential people in the life-sciences industry. François was recognized for his pivotal role in developing and promoting Central Statistical Monitoring (CSM), a ground-breaking concept that is transforming the assessment of data quality in clinical trials.

François was also acknowledged for his personable, energetic and approachable management style, which has earned him deserved respect from the industry and his team at CluePoints, and sets him apart as a truly inspirational leader. Since its launch in 2005, the PharmaVOICE 100 has been celebrating those exceptional professionals in the life-sciences industry who provide inspiration to their peers, colleagues, and companies through their innovative and motivational approaches to addressing the industry’s myriad challenges.

Commenting on the award, François said: “I am immensely honored to have been recognized by PharmaVOICE. This achievement is really a testament to the dedication of the entire CluePoints team, who have shown unwavering commitment to continuously developing and building on the capabilities of our technology, and who share my passion and belief in the benefits CSM can bring to patients, sponsors, CROs, and sites.

“Over recent years, CluePoints has helped to shape the industry’s discussion on quality management and inspired many organizations to re-think their approach to centralized monitoring techniques as they seek to implement risk-based monitoring. This is something I’m extremely proud to have been part of.”
Under François’ leadership, CluePoints has been recognized for several prestigious industry awards, including its recent Clinical & Research Excellence Awards nomination.

For further information on CluePoints’ solutions, please visit

About CluePoints

CluePoints is the premier provider of Risk-Based Monitoring and Data Quality Oversight Software. Our products utilize statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and the new ICH (E6) addendum, CluePoints is deployed to support traditional monitoring and data management and can be implemented as the ultimate engine to drive Risk-Based Monitoring. The value of CluePoints lies in its powerful and timely ability to identify anomalous data and site errors allowing optimization of central and on-site monitoring and a significant reduction in overall regulatory submission risk.

Media contact

Patrick Hughes – Chief Commercial Officer, CluePoints
+44 (0) 7703 532 749