Author: Patrick Hughes, Co-Founder & Chief Commercial Officer, CluePoints
As CluePoints celebrates ten years as the leading provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management (RBQM) software for clinical trials, co-founder Patrick Hughes looks back on the changes the company has undergone in that time – as well as takes a broader look at the industry’s significant shifts since 2012.
1. Growing the team
CluePoints has been undergoing exciting international growth and expanded our teams in Belgium, the United States, and the United Kingdom in recent years. We have recruited 68 people in the past two years alone. What is particularly unusual is that because of the pandemic, we didn’t meet many of them in person until November 2021.
Part of this expansion has included several support staff to assist with data analysis and proposal development elements to finetune how we do business. At the same time, we have introduced new tools to help our people better understand the opportunities. For example, tools like Zymewire helps us better understand our customer base, where they are running trials, and who is involved.
2. Changing the way we hire people
Working remotely has called for alternate ways to assess the suitability of candidates and the areas to which they are best suited. Our commercial team has started implementing psychometric testing to evaluate the skills and abilities of job applicants to see how they best fit with the organization. This has been incredibly useful in a pandemic when we haven’t been able to meet face to face and, in some cases, has even highlighted how people can plug an unmet need with a particular aptitude they can bring.
3. Getting serious about the well-being of our people
Our understanding of people’s health and well-being and how to protect that has improved dramatically in the past few years. As a result, we have taken extra steps to ensure everyone in the CluePoints family is adequately looked after. For example, we sent care packages to people at home during the pandemic. Hence, they knew we were thinking about them, and we regularly host virtual bingo games and other group activities.
We also created a new position, VP of People. We hired Céline Daubresse to take on the responsibility for the overall experience of our people and ensure we attract, develop, and retain the very best talent.
We are now faced with the challenge of getting people to return to the office so that everyone feels comfortable and safe, creating a productive environment that people want to return to, and giving us all the opportunity to spark off one another again. We want to create a sense that we are all in it together – but at the same time, there is a much greater degree of flexibility and freedom in how we work these days. If somebody needs time away for any reason, we all understand that: as long as you are getting the job done, we don’t necessarily mind when that happens.
4. Prioritizing customer success
During the pandemic, we set up a customer success team to support our clients and help them to grow. The team worked to tackle the challenges our clients faced in operating remotely by considering how we could help them install solutions to get the results they wanted. Having a unit purely dedicated to helping meet our customers’ needs has consolidated our relationships and helped to set us apart.
5. Communicating differently
The way we communicate has changed almost beyond recognition in the past decade. Of course, the pandemic accelerated that pace. Still, there was already a significant shift towards platforms like Zoom and Teams for us as a company spread across three countries and two continents! We have embraced all these new means of communication here at CluePoints to enable remote working. Still, there is no replacement for face-to-face interaction with colleagues to generate new ideas and unexpected collaborations.
6. Getting creative about marketing
Traditionally, one of our primary channels of raising the profile of CluePoints has been at trade shows and events, but when they ceased in 2020, we had to think more creatively about how we reached our audience. One response has been our support of RBQM Live, which brings together industry experts to share insights and discuss the acceleration of RBQM. The 2021 event saw 1,500 registrations, highlighting the industry’s focus on these techniques and their importance to its progression. Remote events like this have allowed people to discuss the key issues the sector is facing while in-person events are still making a comeback.
7. Changing the trial model
The fact that study teams were unable to conduct site visits during the pandemic helped us demonstrate how CluePoints’ solutions offer the ability to mine data without being there to carry out monitoring in person. We have seen a number of pharma companies reduce data source verification by 60% and some by 100%. We have been able to offer a solution that supports the remote analysis and interrogation of the data, so researchers don’t have to perform tasks on site anymore. They can be conducted even more accurately and infinitely more quickly by doing it remotely – and you can trust that no stone has been left unturned in the clinical and operational data analysis. There was an initial perception that a remote, risk-based approach would be worse, but the reverse is true: you have a more efficient and less risky approach.
8. Moving to decentralized trials
The wider shift to a decentralized clinical trial model calls for even greater oversight as data is potentially being collected everywhere. With the greater reliance on electronic or patient-reported outcomes and trials taking place outside a clinical investigational site, CluePoints provides the ideal solution: provide us with the data so we can analyze it and concentrate efforts to ensure nothing is going awry.
9. Gaining backing from regulators
It has been extremely encouraging to see the regulatory authorities throw their sizeable weight behind the value of data quality and integrity to enhance safety and improve outcomes. Not only do our solutions align with the latest FDA guidelines, but the recent MHRA’s updated Good Clinical Practice guidance on Oversight and Monitoring Activities included a CluePoints case study to demonstrate the value of centralized statistical monitoring. Additionally, the R3 iteration of the ICH E6 Guidelines for Good Clinical Practice emphasized quality by design, underscoring the value of a risk-based approach.
10. Assisting in Covid drug development
Last but certainly not least, we have been able to support the development of the Covid vaccines which have helped the world return to the new normal following the pandemic. Several drugs were brought to market with record speed with our help, and we have already won two awards for our work in collaboration with BioNTech and Pfizer.
The Scrip Award recognized CluePoints’ support for BioNTech and Pfizer on their Phase I/II/III study of the SARS-COV-2 RNA vaccine BNT162b2 (Comirnaty). Data was analyzed daily rather than the typical monthly or quarterly review, which meant that data quality issues could be identified and rectified rapidly.
CluePoints were also awarded the Citeline Award for Excellence in Innovation in Response to COVID-19 for deploying its risk-based quality management (RBQM) software to support the pivotal trial of the Pfizer/BioNTech BNT162b2 COVID-19 vaccine. The implementation of CluePoints’ solutions enabled the Pfizer/BioNTech product to become the first COVID-19 vaccine to receive regulatory approval just 266 days after the pandemic declaration – and hundreds of millions of doses have since been administered around the globe.
Our solutions ensure the data quality and integrity are beyond reproach when you do things at breakneck speed. As a result, we helped to provide a global solution to the pandemic as drug companies were able to capitalize on our robust and scalable approach, and that is something which we are all very proud of.