CluePoints Blog

Our Musings on Regulatory Updates, Industry Trends and More!

Subscribe to our Blog
September 22, 2020 in Blog, Uncategorized

Exploring the role of AI and Machine Learning in Clinical Trials

We live in a rapidly evolving digital era shaped by a continuous stream of pioneering technological advances. The world of clinical research is no exception,…
Read More
September 16, 2020 in Blog

Centralized Monitoring – How to Unlock the Treasure Chest of Analytical Insights

Chief Scientific Officer of CluePoints, Steve Young, discusses his thoughts on how Centralized monitoring has started to take off in the clinical trials industry even…
Read More
September 9, 2020 in Blog

Applying Risk-Based Quality Management to Investigator-Led Trials

Medical science is advancing at a never before seen rate, but costs are spiralling meaning clinical trials need to change if they are to ensure…
Read More
September 1, 2020 in Blog, News

CluePoints Joins Forces with Global Growth Investor Summit Partners to Expand Market Leadership Position in Risk-Based Quality Management

LOUVAIN-LA-NEUVE, BELGIUM; KING OF PRUSSIA, PA; and LONDON, UK (September 1, 2020) – CluePoints S.A., a provider of Risk-Based Study Execution (RBx) and Data Quality…
Read More
August 31, 2020 in Blog

From Risk-Based Monitoring to Risk-Based Quality Management

A review of FDA marketing submissions between 2000 and 2012 revealed roughly one- third (32%) of all first-cycle review failures (16% of submissions overall) were…
Read More
August 5, 2020 in Blog

Webinar: The Future of Clinical Trial Monitoring

In the wake of COVID-19, adoption of decentralized clinical research is taking off as sponsors explore ways to maintain continuity for existing studies while looking…
Read More
August 4, 2020 in Blog, News

Over 300 Clinical Studies Benefit from CluePoints’ COVID-19 Risk Management Support

Addressing COVID-19 Specific Regulatory Guidance and Ensuring Early Risk Detection   King of Prussia, PA  – August 4th, 2020: CluePoints, the premier provider of Risk-Based…
Read More
July 20, 2020 in Blog

New Paper: From RBM to RBQM – The Future of Risk-Based Trial Management

A review of FDA marketing submissions between 2000 and 2012 revealed roughly one-third (32%) of all first-cycle review failures (16% of submissions overall) were driven…
Read More
July 13, 2020 in Blog, News

CluePoints & DIA Webinar: How is the Industry Coping with the Move to Remote Monitoring?

On July 28, CluePoints is teaming up with DIA for a webinar to explore how the clinical research industry is coping with the move to…
Read More
July 1, 2020 in Blog

RBQM Doesn’t have to be Complicated, Risky or Expensive: Q&A

On Wednesday, June 24, 2020, CluePoints delivered a webinar to demonstrate how using a combination of powerful analytics and comprehensive data visualization can be employed…
Read More
June 25, 2020 in Blog, News

CluePoints Launches Powerful Business Intelligence Platform

Personalizing the Power of Statistical Analysis and Data Visualization King of Prussia, PA  – June 26, 2020: CluePoints, the premier provider of Risk-Based Study Execution…
Read More
June 2, 2020 in Blog

New Webinar: Risk-Based Quality Management Doesn’t have to be Complicated, Risky or Expensive!

Register Now for our June 24, 2020 Webinar:Risk Detection and Data Visualization Techniques that Actually Deliver on the Promise. Managing and mitigating risk, particularly in…
Read More
May 7, 2020 in Blog, COVID-19, News

CluePoints Covid-19 Support Benefits Over 200 Clinical Studies Directly Affected by the Pandemic

RISK MANAGEMENT SOLUTION ADDRESSES FDA, EMA, PMDA & MHRA CORONAVIRUS ADVICE King of Prussia, PA  – May 07, 2020: CluePoints, the premier provider of Risk-Based…
Read More
April 30, 2020 in Blog, COVID-19, COVID-19 Webinar

Beyond COVID-19: The New Normal in Risk-Based Monitoring (RBM) and Quality Management (RBQM)

Join our next webinar to learn first-hand how the CluePoints and Parexel partnership is driving best-in-class Risk-Based Quality Management Strategies to support clinical development. This…
Read More
April 14, 2020 in Blog, News

EPS Corporation Signs Groundbreaking Agreement To Drive Increased Quality And Safety Using CluePoints RBQM Solution

King of Prussia, PA  – April 14, 2020: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials,…
Read More
April 7, 2020 in Blog, COVID-19, Uncategorized

Early Risk Detection During the COVID-19 Crisis – Your Questions Answered

On Tuesday, March 31, 2020, CluePoints delivered a webinar centred around the critical importance of early risk detection. Our presenter also shared insights on how…
Read More
April 6, 2020 in Blog, COVID-19, News

CluePoints Launches Complimentary COVID-19 Risk Management Package for Clinical Studies

Risk Planning Guidance Addresses FDA, EMA, PMDA and MHRA Coronavirus Advice King of Prussia, PA  – April 06, 2020: CluePoints, the premier provider of Risk-Based…
Read More
April 1, 2020 in Blog, COVID-19, COVID-19 Webinar, News

Webinar Recording: The Critical Importance of Early Risk Detection with a Special Feature Addressing COVID-19

We're delighted to announce that the recording for our COVID-19 webinar has been posted! The clinical research industry is in the midst of adopting Risk-Based…
Read More
March 30, 2020 in Blog, COVID-19

Complimentary COVID-19 Risk Assessment Package Available To All at No Cost

As advised in the coronavirus guidances recently issued by FDA, EMA, and MHRA, it is important to perform a fresh risk assessment for each study…
Read More
March 18, 2020 in Blog, News

CluePoints’ Central Statistical Monitoring Supports Business Continuity as Coronavirus Impacts Clinical Trial Operations

MITIGATING THE IMPACT ON SITE MONITORING EFFORTS DUE TO COVID-19 King of Prussia, PA  – March 18, 2020: CluePoints, the premier provider of Risk-Based Trial…
Read More
March 17, 2020 in Blog

Registration Open for our Risk-Based Quality Management Insights Webinar

Please join us for our March 31, 2020 webinar: RBQM Insights - Understanding the Critical Importance of Early Risk Detection (With a Special Feature Addressing…
Read More
February 25, 2020 in Blog

Risk-Based Quality Management – It’s now a Question of “how” Rather than “if”

Risk-based quality management (RBQM) solutions offer sponsors and CROs a better way of detecting and managing risks that may impact the outcome of clinical trials.…
Read More
December 10, 2019 in Blog

Implementing a Risk-Based Quality Management Strategy – The Ultimate Guide

Every organization faces unique challenges when it comes to implementing a Risk-Based Quality Management strategy. There’s no ‘one-size-fits-all’ approach that will ensure success, as each organization…
Read More
December 5, 2019 in Awards, Blog, News

CluePoints’ Risk-Based Quality Management (RBQM) Software Wins at Scrip Awards 2019

King of Prussia, PA – December 5, 2019: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software for clinical trials, today…
Read More
October 22, 2019 in Awards, Blog, News

As Demand for RBx Soars CluePoints Continues Global Expansion Alongside Further Award Wins

KING OF PRUSSIA, PA – October 22, 2019: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials,…
Read More
September 10, 2019 in Blog, News

FDA Extends CRADA with CluePoints to Further Explore a Data-Driven Approach to Quality Oversight in Clinical Trials

KING OF PRUSSIA, PA, 10 September 2019– FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection…
Read More
August 22, 2019 in Blog, News

ICH E6 (R2) Compliance Webinar Series Available to Watch Now!

"I KNOW ICH E6 (R2) COMPLIANCE  INSISTS ON A RISK-BASED APPROACH TO RUNNING MY TRIALS, BUT HOW AM I GOING TO IMPLEMENT THIS AND REALIZE…
Read More
June 18, 2019 in Blog, News

Parexel Strengthens Risk-Based Monitoring Offering with CluePoints’ New Advanced Statistical Capabilities

Strategic collaboration leverages CluePoints’ Central Statistical Monitoring (CSM) technology to enhance data quality and reduce operational costs. WAYNE, PA, June 18, 2019– Parexel, a leading…
Read More
April 9, 2019 in Blog, News

CluePoints Experiences Continued Rapid Growth as Demand for RBx Rises

WAYNE, PA – April 09, 2019: CluePoints, a leading provider of Risk-Based Study Execution(RBx) and Data Quality Oversight solutions for clinical trials, has announced a…
Read More
March 18, 2019 in Blog

Transitioning from a Risk-Based Monitoring Approach to Risk-based Quality Management

This content was originally posted on Applied Clinical Trials on March 18, 2019 One of the most significant positive changes we have seen recently is the endorsement…
Read More
February 27, 2019 in Blog

Risk-Based Study Execution (RBx) – It’s Time to Close the Loop!

When the journey started it was all about monitoring. It was about addressing the inefficiencies, rationalizing resources to reduce costs and tackle potential quality issues…
Read More
December 13, 2018 in Blog, News

New! Registration Open for CluePoints’ RBM Roadshows – Pick from San Francisco or La Jolla!

We’re delighted to announce that registration for CluePoints’ US Risk-Based Quality Management Roadshow is now open. Taking place in January 2019, these roadshows will provide you the opportunity to…
Read More
October 22, 2018 in Blog, News

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…
Read More
October 19, 2018 in Blog, News

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…
Read More
October 15, 2018 in Blog, News

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…
Read More
October 1, 2018 in Blog, News

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…
Read More
September 25, 2018 in Blog, News

Quanticate partners with CluePoints to offer Data Quality Oversight capabilities

Quanticate, a data-focused clinical research organisation (CRO), has announced that it has partnered with CluePoints to utilize their software to drive the statistical analysis to perform…
Read More
August 13, 2018 in Blog, News

The CluePoints & HighPoint Solutions RBM Roadshow is Coming to a City Near You!

Since the initial publication of the ICH GCP guidelines, the way clinical trials operate has changed significantly. The ICH E6 (R2) addendum, which came into effect in June…
Read More
July 19, 2018 in Blog, News

CluePoints Awarded Most Reputable Clinical Trial Risk-Based Monitoring Software 2018

It appears that 2018 is the year CluePoints really established itself as a leader in the industry! Having recently being honoured in the Biotechnology Awards…
Read More
July 9, 2018 in Blog, News

CluePoints Announces Four Year Partnership with ONO Pharmaceutical and Strengthens Risk-Based Monitoring Position in Japan

July 9, 2018 Wayne, PA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has entered into…
Read More
June 11, 2018 in Blog

ICH E6 R2 – The Clinical R&D Industry’s Response

For decades now the complexity, cost, and duration of clinical development have been steadily increasing while profit margins for the industry have been dwindling. This…
Read More
February 8, 2018 in Blog

New Webinar Announced: Risk-Based Monitoring for All

Please join us for our upcoming webinar: Risk-Based Monitoring for All - How the ICH E6 (R2) has given clinical development organizations the perfect opportunity to…
Read More
January 31, 2018 in Blog, News

CluePoints Wins Best Risk-Based Monitoring Solution in 2018 Biotechnology Awards

January 31, 2018 Wayne, PA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has been honoured…
Read More
January 22, 2018 in Blog, News

CluePoints Launches Risk-Based Monitoring Starter Pack to Drive Regulatory Compliance

22 January 2018 Wayne, PA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has launched the…
Read More
December 5, 2017 in Blog, News

CluePoints Responds to Sponsor and CRO Demand with Two New Appointments

5 December 2017 Wayne, PA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has announced two new…
Read More
November 8, 2017 in Blog

Beyond Risk-Based Monitoring: How Intelligent Analytics are Being Used to Drive Value and Support ICH Compliance

The complexity and size of clinical trials has increased dramatically – in parallel with growing costs and mounting regulatory pressures. The introduction of the finalized International…
Read More
November 5, 2017 in Blog

The Bigger Picture of ICH E6 R2: Looking Beyond Compliance

Journal for Clinical Studies Steve Young, Chief Operations Officer, CluePoints The introduction of ICH E6 (R2) this past year has rendered the implementation of risk-based…
Read More
November 3, 2017 in Blog, News

CluePoints Builds on Late Phase work in Japan and Launches Risk-Based Monitoring Roadshow in Tokyo

Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has further expanded its Late Phase…
Read More
October 30, 2017 in Blog, News

25% Discount Code for Partnerships in Clinical Trials 2017

We’re delighted to announce that we’ll be at Partnerships in Clinical Trials next month! You can find us at booth 120, where we’ll be showcasing…
Read More
October 23, 2017 in Blog

ICH E6 R2: Talking Big Pharma’s Response To The Addendum

This article was originally produced for Clinical Informatics News The introduction and implementation of ICH E6 R2 has raised many questions surrounding operational risk-based approaches to…
Read More
September 25, 2017 in Blog, News

CluePoints V1.12.0 is Live!

Today, we’re excited to announce that we’ve added an abundance of new features to the CluePoints Central Monitoring platform. From out-of-the-box integration for data sources…
Read More
September 6, 2017 in Blog, News

Eight Reasons Why You Need to Attend CBI’s Global Risk-Based Monitoring Event

This month, experts from across the globe will gather for CBI’s Global Risk-Based Monitoring event, taking place on September 14-15.  If you haven’t decided if you’re attending…
Read More
August 28, 2017 in Blog, News

Explore the ICH E6 Rev2 at Outsourcing in Clinical Trials New England

Arena International’s flagship event, Outsourcing in Clinical Trials New England, is almost upon us. This year’s edition, taking place on September 6-7, 2017, at The…
Read More
August 8, 2017 in Blog

ICH E6 R2 Roundtable Review – What Does This Mean for the Industry?

The release of the ICH E6 R2 guidance, which outlines a new approach to clinical trials operations, will have a major impact on the industry.…
Read More
June 23, 2017 in Blog

ICH E6 R2: Waiting and Watching no Longer an Option When it Comes to Risk-Based Monitoring

As is typical of our industry, despite ringing endorsements of Risk-Based Monitoring (RBM) from both the FDA and EMA back in 2013, researchers have been…
Read More
May 2, 2017 in Blog, News

CluePoints Opens U.S. Office

2 May 2017 Wayne, PA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, today announced that…
Read More
April 18, 2017 in Blog, News

CluePoints’ Founder to Present on Risk-Based Monitoring at FDA/AdvaMed Conference

The 10th Annual FDA/ADVAMED Medical Devices and Diagnostics Statistical Issues Conference, taking place on April 26, 2017 to April 27, 2017, brings together leading authorities…
Read More
April 5, 2017 in Blog

ICH E6 (R2) – Miracle Pill for the Clinical R&D Industry

ACRP Clinical Researcher ICH E6 R2 – Miracle Pill for the Clinical R&D Industry Steve Young, Chief Operations Officer, CluePoints Publication of the long-awaited ICH…
Read More
March 23, 2017 in Blog

ICH E6 Rev 2 – Ask the Experts

Last week, we hosted our second webinar of 2017, Implementing Risk-Based Monitoring – What Does the ICH E6 Rev 2 Mean for My Company? There…
Read More
March 16, 2017 in Blog

Webinar Recording: What Does ICH E6 R2 Mean for Me and My Company?

This week, CluePoints hosted a webinar with Paragon Solutions, which was geared towards preparing attendees on how to take advantage of the ICH E6 revisions…
Read More
March 13, 2017 in Blog, News

CluePoints Launches Patient Profiles as Latest Addition to its Risk-Based Monitoring and Data Quality Oversight Solution

13 March 2017 Cambridge, MA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has introduced Patient…
Read More
March 9, 2017 in Blog, News

CluePoints COO, Steve Young, to Present on Statistical Probability Analysis at MCC’s Central Monitoring Workgroup

The Central Monitoring Workgroup will feature speakers from several solution providers who will each present and discuss the types of analytic methods that are relevant…
Read More
February 28, 2017 in Blog, News

Patient Profiles unveiled as latest addition to CluePoints’ Risk-Based Monitoring and Data Quality Oversight solution

We’re thrilled to announce that version 1.11.0 of CluePoints’ Central Monitoring platform, the enabling SaaS platform for Risk-Based Monitoring,  will be available to users in…
Read More
February 21, 2017 in Blog

6th Annual CROWN Congress: Sessions you Can’t Afford to Miss + 15% Discount Code

It’s really no secret that the evolving regulatory landscape for clinical trials is a hot topic amongst the community. Just take a look at the agenda…
Read More
February 13, 2017 in Blog

Six Ways to Get the Most out of Outsourcing in Clinical Trials West Coast ‘17

There’s only a couple of weeks to go until Arena’s flagship event, Outsourcing in Clinical Trials West Coast returns to Burlingame. The must-attend event brings…
Read More
February 6, 2017 in Blog, News

CluePoints’ Risk-Based Monitoring Solution Receives Clinical Informatics News Best Practices Award

Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring solutions for clinical trials, today announced that it has won a Clinical Informatics News Best…
Read More
January 31, 2017 in Blog

The FDA is Knocking at your Door – Are you Ready for an FDA Site Inspection?

Are you ready for an FDA site inspection? You may have heard that CluePoints signed an agreement with the FDA. This Cooperative Research and Development…
Read More
January 27, 2017 in Blog

Webinar: Risk-Based Monitoring Implementation – What does ICH E6 Rev2 Mean for My Company?

With the official publication of the long awaited revision of the ICH E6 Guidelines, now is the time to take advantage of the new information to…
Read More
January 17, 2017 in Blog, News

CluePoints – Finalists in The Clinical Informatics News 2017 Best Practices Awards at SCOPE, Jan 24th – 26th in Miami

We’re thrilled to announce that CluePoints has been named as finalists for the Clinical Informatics News 2017 Best Practices Awards, for our award-winning Risk-Based Monitoring…
Read More
January 12, 2017 in Blog, News

CluePoints CEO, Francois Torche, to Present at SCOPE Summit for Clinical Ops Executives

The 8th Annual SCOPE Summit for Clinical Ops Executives, taking place on January 24-26, 2017 in Miami, FL, will offer three stimulating days of in-depth…
Read More
November 8, 2016 in Blog, News

CluePoints Partners with Metrics Champion Consortium to Define Metrics and Standards for Centralized Monitoring

8 November 2016 Cambridge, MA - CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) and Risk-Based Monitoring(RBM) solutions for clinical trials, announces its partnership with…
Read More
October 31, 2016 in Blog, News

CluePoints Introduces Data Quality Oversight Service for Site Inspection Readiness

31 October 2016 Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Centralized Statistical Monitoring (CSM) solutions for clinical trials, today announced…
Read More
October 12, 2016 in Blog, News

FDA Signs Agreement with CluePoints to Explore a Data-Driven Approach to Quality Oversight in Clinical Trials

12 October 2016 Cambridge, MA -  FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of…
Read More
October 5, 2016 in Blog, News

CluePoints Teams up with Paragon Solutions to Share the Secrets of Successful Risk-Based Monitoring Implementation

We’re delighted to announce that are our next Risk-Based Monitoring implementation webinar is open for registration! Register now – this is THE Risk-Based Monitoring webinar…
Read More
September 24, 2016 in Blog, News

CluePoints Announces Locations for Risk-Based Monitoring Implementation Roadshows

The CluePoints and OmniComm Risk-Based Monitoring Implementation Roadshow is Coming to a City Near You! In response to the rising complexity and cost of clinical…
Read More
September 23, 2016 in Blog

CluePoints Answers your Risk-Based Monitoring Implementation Questions

Q1) Are the indicators percentages? E.g., % AEs for the site v study or just number (which could indicate that there are many AEs as…
Read More
August 24, 2016 in Blog, News

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…
Read More
August 18, 2016 in Blog

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…
Read More
August 16, 2016 in Blog, News

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…
Read More
August 1, 2016 in News

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…
Read More
July 28, 2016 in Blog, News

CluePoints Risk-Based Monitoring Platform (Version 1.9.0) is Live!

We’re thrilled to announce that CluePoints’ latest version (1.9.0) of the Central Monitoring platform is live!  Version 1.9.0 adds an abundance of new features (as requested by…
Read More
July 18, 2016 in Blog, News

CluePoints Founder, Marc Buyse to Deliver Clinical Trial Data Quality Course at the ASA Biopharmaceutical Workshop

The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is fast approaching and we’re thrilled to announce that CluePoints Founder, Marc Buyse will deliver a course with…
Read More
July 14, 2016 in Blog

Risk-Based Monitoring Insights from the Industry: Jamie O’Keefe

Part Six In the latest of our eight-part Q&A series, we catch up with Jamie O’Keefe, Vice President, Life Sciences, and R&D Practice at Paragon Solutions to…
Read More
July 6, 2016 in Blog

Is Risk-Based Monitoring the Answer to Data Quality Issues?

It’s no secret that data quality is at the heart of every clinical trial. Data validation is one of the main objectives in the FDA’s…
Read More
June 16, 2016 in Blog

Risk-Based Monitoring Insights from the Industry: Steve Young

Part Five We’ve heard some great insights on the current hot topics in Risk-Based Monitoring (RBM) from a number of leading experts over recent weeks.…
Read More
June 9, 2016 in Blog

Defining Clinical Trial Thresholds: Objective Vs Subjective?

Over the past few weeks, we’ve been discussing the thoughts of some of the leading experts in Risk-Based Monitoring, and we’ve really appreciated those of…
Read More
June 1, 2016 in Blog

Central Statistical Monitoring Should Support Key Risk Indicators

As you may well know, much of the early work in Risk-Based Monitoring has focused on relatively simple Key Risk Indicators (KRIs) and traffic-light dashboards,…
Read More
May 30, 2016 in Blog

Are the Regulatory Authorities Ready for the Adoption of Risk-Based Monitoring?

Firstly, thanks to those of you who got involved with our recent discussion about current best practice in Risk-Based Monitoring, it was great to hear…
Read More
May 26, 2016 in Blog

Risk-Based Monitoring Insights from the Industry: Dr. Peter Schiemann

In the fourth installment of the CluePoints Risk-Based Monitoring Q&A series, we spoke to Dr. Peter Schiemann, Managing Partner and Co-Founder of Widler & Schiemann, who…
Read More
May 18, 2016 in Blog

How will Risk-Based Monitoring Coexist with other Clinical Trial Technology?

We’ve been really enjoying hearing your thoughts on the latest Risk-Based Monitoring hot topics over the last few weeks, so thank you to everyone who…
Read More
May 11, 2016 in Blog

Risk-Based Monitoring Insights from the Industry: Karen Fanouillere

Part Three In the third of an eight-part Q&A series which aims to explore some of the current hot topics in Risk-Based Monitoring (RBM), CluePoints…
Read More
April 29, 2016 in Blog, News

Unveiling CluePoints’ New and Improved Risk-Based Monitoring Software

Today, we’re thrilled to unveil CluePoints’ latest release of its award-winning Risk-Based Monitoring Software. For this release, we wanted to hone in on several customer…
Read More
April 27, 2016 in Blog

Risk-Based Monitoring Insights from the Industry: Adam Butler

Part Two Recently, CluePoints has been taking time out with some of our valued partners to discuss hot topics in Risk-Based Monitoring (RBM). Here, in…
Read More
April 25, 2016 in Blog

Is it too soon to Define Best Practice When it Comes to the Practical Implementation of Risk-Based Monitoring?

Last week CluePoints launched its eight-part Q&A blog series which aims to explore the current talking points in Risk-Based Monitoring (RBM). We’ve been gathering insights…
Read More
April 13, 2016 in Blog

Risk-Based Monitoring Insights from the Industry: Craig Serra

Part One In the first of an eight-part Q&A series which aims to explore some of the current hot topics in Risk-Based Monitoring (RBM), CluePoints…
Read More
April 1, 2016 in Blog, News

CluePoints Announce 2nd Annual Risk-Based Monitoring Roadshows to take place in Basel, Switzerland & Cambridge, UK

Join CluePoints CEO Francois Torche and OmniComm Sr. Director Steve Young at this special thought leadership event where you will hear about the benefits derived from an integrated…
Read More
March 14, 2016 in News

CluePoints Named Clinical Research & Excellence Awards Finalist

Awards recognize CluePoints’ Risk-Based Monitoring solution in the ‘Best Sponsor-Focused Technological Development’ category Cambridge, MA - CluePoints, a leading software provider of Risk-Based Monitoring (RBM)…
Read More
January 27, 2016 in Blog

TransCelerate’s RACT: How to Deploy the Methodology Efficiently in Clinical Trials

TransCelerate has led the way in conducting research to help sponsors and CROs identify and facilitate the implementation of solutions to drive efficient delivery of…
Read More
January 9, 2016 in Blog

Transcelerate’s Latest Paper – “Detecting Data Quality Issues in Clinical Trials: Current Practices and Recommendations”

Pressure is growing for sponsors to implement robust controls to identify data quality issues that may impact trial outcomes, and this is understandable given the…
Read More
November 2, 2015 in News

CluePoints and Widler & Schiemann Collaborate on Complete Risk-Management Solution for Clinical Trials in Line with New Industry Guidance

Partnership will combine CluePoints' Risk-Based Monitoring Software with Widler & Schiemann's Consultancy Services 2 November 2015 Cambridge, MA - CluePoints, a leading software provider of…
Read More
October 20, 2015 in News

CluePoints Partners with OmniComm Systems® to Offer Collective Risk-Based Monitoring & Electronic Data Capture Solution

Strategic collaboration enables customers to harness the value of data capture coupled with data quality oversight 20 October 2015 Cambridge, MA - CluePoints, a leading…
Read More
October 6, 2015 in News

CluePoints Announces Partnership with Bracket for CNS Trials

Strategic partnership will bring together CluePoints' Risk-Based Monitoring Software with Bracket's Rater Training and Quality Assurance Services for CNS trials 6 October 2015 Cambridge, MA…
Read More
August 3, 2015 in News

CluePoints Chief Commercial Officer Named in PharmaVOICE 100

3 August 2015 Cambridge, MA - CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has today announced that its Chief…
Read More
July 23, 2015 in News

CluePoints Receives € 6million Growth Investment

  Funding will grow both operations and business development in the U.S 23 July 2015 Cambridge, MA - CluePoints, a leading software provider of risk-based…
Read More
June 15, 2015 in News

Risk-Based Monitoring Software for Operational Data Analysis

15 June 2015 Cambridge, MA - CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, today introduced software to enable analyses…
Read More
May 18, 2015 in News

CluePoints Announces U.S Patent Allowance for SMART™ Engine

18 May 2015 Cambridge, MA - CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, today announced that the United States…
Read More
April 22, 2015 in News

CluePoints’ CSM Solution with Oracle Health Sciences Cloud Can Enable Proactive RBM and Improve Data Quality

Combined solution can help identify trial risks in operational and clinical data before traditional methods 22 April 2015 Cambridge, MA - CluePoints, a leading provider…
Read More
March 26, 2015 in News

CluePoints and ACRES Partner to Improve Data Quality in Clinical Research

CluePoints and the Alliance for Clinical Research Excellence and Safety (ACRES) announce a strategic agreement to join forces in identifying potential risks to the quality…
Read More
January 12, 2015 in News

CluePoints SaaS Solution Demonstrates Improved Data Integrity & Quality by Putting Sponsors in Control of Risk-Based Monitoring

Central Statistical Monitoring solution tested by sponsors for ability to independently detect & interrogate anomalies in clinical trial data 12 January 2015 Cambridge, MA -…
Read More
December 4, 2014 in News

CluePoints Wins Award for Best Technological Development in Clinical Trials

Company wins prestigious accolade for its Risk-Based Monitoring Software at the 2014 Scrip Awards We are delighted to announce that CluePoints won the Scrip Award…
Read More
October 30, 2014 in News

CluePoints Wins ENTENTE Life Science Investment Forum Award

  Win marks second award for CluePoints this month 9 December 2014 Cambridge, MA - CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical…
Read More
September 16, 2014 in News

CluePoints Used to Checked Data Quality in Large Phase III Gastric Cancer Trial

  CluePoints selected by the Nagoya University School of Medicine to assess data quality and integrity 16 September 2014 Cambridge, MA - CluePoints, a leading…
Read More
September 11, 2014 in Blog

Want Full Control of Your Risk-Based Monitoring Analyses?

CluePoints introduces a web-based Central Statistical Monitoring (CSM) SaaS solution As you may have read on a few industry blogs, we recently launched a Software-as-a-Service…
Read More
February 25, 2014 in News

CluePoints Strengthens and Expands Global Team in Growing Risk-Based Monitoring Market

  Company announces new board and business development appointments 25th February 2014 Cambridge, MA - CluePoints, a leading provider of Risk-Based Monitoring (RBM) solutions for…
Read More
February 1, 2014 in News

EMA Guidance Points to Central Statistical Monitoring

While capable of conducting high-quality trials, the current oversight process can be expensive and inefficient. February 1, 2014 By Marc Buyse, ScD Read the article…
Read More
January 27, 2014 in Blog

The Evolution of CluePoints’ SMART Engine

Regarding CluePoints' statistical approach to risk-based monitoring in clinical trials, we are often asked questions about sample size, such as: "How many subjects are needed per site…
Read More
December 6, 2013 in Blog

CluePoints’ Commentary – EMA Reflection Paper on Risk Based Quality Management in Clinical Trials

The final version of the EMA Reflection Paper on Risk Based Quality Management in Clinical Trials is now available. This document, as well as the…
Read More
November 7, 2013 in Blog

A CluePoints Case Study: Confirmation of Fraud – Diaries Completed by Staff

In a phase III trial in vascular disease, over 4,500 patients were randomized across 160 sites. The CRF included 480 variables for 32 domains. The…
Read More
September 26, 2013 in Blog

Risk-Based Management and the Difference Between Key Risk Indicators and Central Statistical Monitoring

ClueBot here! Did you miss me? I’ve actually dropped by to share some exciting news.  A few months ago, my wonderful creator at CluePoints, Dr…
Read More
August 12, 2013 in News

CluePoints Cited in New FDA Guidance

  12 August 2013 Cambridge, MA - CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced that its CSM…
Read More
August 11, 2013 in Blog

New FDA Guidance Encourages Sponsors to Use Centralized Statistical Monitoring for Improved Data Quality

https://www.youtube.com/watch?v=1pxNwHQiFNY&feature=youtu.be Background The recent release of the final guidance document detailing the FDA’s stance on the “Oversight of Clinical Investigations” is welcome news for the…
Read More
July 12, 2013 in Blog

Introducing your host: ClueBot!

and I will be bringing to you new and exciting topics in the areas of Risk-Based Monitoring in clinical trials. Some of you may have…
Read More
April 22, 2013 in Blog

CluePoints Launches Powerful & Pragmatic Solution to Risk-Based Monitoring

As biopharmaceutical sponsors search for the optimal approach to targeted monitoring and reduced  Source Data Verification (SDV), CluePoints introduces an Intelligent Statistical approach like no…
Read More