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Latest Industry Updates

From company milestones to industry breakthroughs, uncover the stories making waves and shaping the narrative in real time.

Potential Pitfalls Without RBQM Adoption
In part 4 of this video interview series, Ken Getz, executive director and research professor, Tufts...
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Increasing Comfortability With Adopting Risk-Based Approaches
In part 3 of this video interview series, Ken Getz, executive director and research professor, Tufts...
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Ken Getz of Tufts CSDD and Steve Young of CluePoints Discuss Stand Out Results from Recent RBQM Study
In part 2 of this video interview series, Ken Getz, executive director and research professor, Tufts...
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Ken Getz of Tufts CSDD Discusses RBQM Study Conducted with CluePoints and PwC
In part 1 of this video interview series with Ken Getz, executive director and research professor, Tufts...
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Clinical Research 2.0 Must Embrace Change
We are at a tipping point in the adoption of Clinical Research 2.0. The evolution of risk-based quality...
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Women in Science: Dr Laura Trotta - 'I joined CluePoints because of the research but also the mindset'
Dr Laura Trotta joined CluePoints in 2015 and moved into her current role as vice president of research...
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RBQM Elements Have Seen Limited Adoption in Trials, New Global Survey Finds

Despite the push for greater use of risk-based quality management (RBQM) in clinical research, adoption of...

Source: CenterWatch

Industry Trends: Cycle Time to Resolve Risk Signals

Central monitoring aims to detect emerging quality-related risks proactively during a clinical trial, resulting in study...

Source: Applied Clinical Trials

CluePoints, Ken Getz & Tufts CSDD and PwC Unveil New RBQM Insights Report at DIA Global Annual Meeting 2023

King of Prussia, PA – June 20, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

Paving the path for risk-based quality management and sharing insight at DIA Global

CluePoints is continuing to invest in artificial intelligence (AI) and machine learning (ML) they say they...

Source: Outsourcing Pharma

Interview: How CluePoints is making clinical trials ‘safer, streamlined and more efficient’

With the clinical trial landscape continuing to evolve and adapt, OSP took the opportunity to speak...

Source: Outsourcing Pharma

CluePoints Supports Launch of RBQM Live 2023 as Premier Event Sponsor

King of Prussia, PA – May 3, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

CluePoints Announces Amit Patel as New CFO

King of Prussia, PA: RBQM leader, CluePoints, has today announced that Amit Patel will join as...

The Role of KRIs in Process-Driven RBQM Success

Using key risk indicators (KRIs) can improve clinical trial data quality in 80% of the sites...

Source: Applied Clinical Trials

Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters

Since the release of ICH E6(R2), multiple efforts have been made to interpret the requirements and...

Source: Springer Link

Citeline Finalist CluePoints Show Advanced AI Capabilities

King of Prussia, PA – March 23rd, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

Quality Tolerance Limits: A Review of Industry Trends

An expectation for the use of quality tolerance limits (QTLs) was formally established in the International...

Source: Applied Clinical Trials

The Role of Transferable Skills and Data Science in the Move to Digitally-Enabled Clinical Research

Clinical research is evolving rapidly, with the digitalization of trials creating a new modus operandi and...

Source: Applied Clinical Trials

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...

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....

Announcing The CluePoints Data Quality Challenge

Are you struggling with how to assess the true value of improving data quality and integrity...

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...

CluePoints Strengthens Senior Team With Two Key Appointments

Wayne, PA – October 02, 2018: CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data...

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...

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...

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...

CluePoints Announces Four Year Partnership With ONO Pharmaceutical And Strengthens Risk-Based Monitoring Position In Japan

Successful pilot project prompts strategic partnership that strengthens risk-based monitoring in Japan and places both companies...

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

Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions...

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

Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions...

CluePoints Responds To Sponsor And CRO Demand With Two New Appointments

Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions...

Managing Clinical Trials Amid the Coronavirus Pandemic

Amid the ongoing Coronavirus pandemic, clinical trial sites are increasingly inaccessible for patients and site staff,...

Source: Tufts Center for the Study of Drug Development

Effective Risk Management When Using eCOA and ePRO

The use of direct source data capture in clinical research is on the rise, both during...

Source: Clinical Research News

Leveraging Audit Trails to Monitor Clinical Study Risk

The clinical research industry has gone through an important transformation over the past 15 to 20...

Source: ACRP

Using Statistics to Improve Data Quality and Maximize Trial Success

Poor quality data has the potential to destroy the validity of a clinical trial, wasting precious...

Source: Tufts Center for the Study of Drug Development

How ICH E6 (R2) Provides a Win/Win/Win through Risk-Based Study Execution

Participant safety is the clinical trial sector’s top priority – and striving to achieve this laudable...

Source: Applied Clinical Trials

From RBM to RBx: The Keys to Successful Adoption and Implementation

The latest version of the Good Clinical Practice (GCP) quality standard insists that sponsors implement a...

Source: Global Forum

Detection of Atypical Data in Multicenter Clinical Trials Using Unsupervised Statistical Monitoring

A risk-based approach to clinical research may include a central statistical assessment of data quality.

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Source: Sage Journals

Leveraging Intelligent Analytics to Realize the Full Value of RBx and Compliance with ICH E6 (R2)

Not only is there a significant good clinical practice (GCP) expectation, Risk-Based Monitoring (RBM) presents a...

Source: Contract Pharma

FDA Offers Further RBM Guidance Stressing Data Quality Oversight

Since finalizing its risk-based monitoring guidance in 2013, the FDA is providing additional information in a...

Source: Outsourcing Pharma

How SMEs Can Achieve Regulatory Compliance Through a Risk-Based Approach

Since the introduction of the ICH E6 (R2) addendum, the industry has seen a rise in...

Source: Pharma Focus Asia

Update on ICH E6 (R2) Guideline for GCP

The ICH E6 R2 Addendum is starting to have a significant, positive impact on clinical trial...

Source: Contract Pharma

A Revolutionary Cure for RBM and Centralized Monitoring

In the clinical trials industry there is a tendency to watch and wait, which has been...

Source: PharmaIQ