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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.

CluePoints Launches Medical & Safety Review (MSR) Software to Revolutionize Clinical Data Review
CluePoints furthers its commitment to delivering innovative solutions that enhance clinical trial efficiency...
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The Negative Impact of Failing to Implement Risk-Based Quality Management
As an industry, we regularly discuss the benefits of adopting risk-based quality management (RBQM). The...
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There’s No Such Thing as Too Much Data
François Torche dispels the myth that, at least in RBQM, there is such a thing as too much data, and...
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Using RBQM and New Technologies to Enhance Data Analysis and Enable Faster Review and Decision Making
An increase in clinical trial data is driving demand for enhanced clinical trial processes. Sponsors...
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Vox Pop Pharma – where will AI take the industry in the next five years?
Artificial intelligence (AI) is a hot topic in pharma with myriad uses such as supporting clinical research...
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Advancing Technology in Clinical Trials
With increasing pressure to overcome drug development challenges and advance drugs to market faster and...
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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...

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...

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...

CluePoints V1.12.0 Is Live!

Today, we’re excited to announce that we’ve added an abundance of new features to the CluePoints...

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...

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...

CluePoints Opens U.S. Office

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

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,...

CluePoints Launches Patient Profiles As Latest Addition To Its Risk-Based Monitoring And Data Quality Oversight Solution

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

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...

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...

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: CluePoints,...

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! About the...

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

Remote monitoring is mitigating the impact of SARS-CoV-2 on clinical trials, marking an acceleration in the...

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

King of Prussia, PA: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality...

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

KING OF PRUSSIA, PA: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality...

FDA Extends CRADA With CluePoints To Further Explore A Data-Driven Approach To Quality Oversight In Clinical Trials

KING OF PRUSSIA, PA– FDA and its stakeholders have an interest in assuring the integrity of...

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...

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...

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...

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

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

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

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

The Eradication of False Signals in Monitoring

Risk-based approaches to monitoring clinical trials were brought to the forefront with an FDA guidance published...

Source: Applied Clinical Trials

Identifying Important Risk Indicators in Clinical Development

Key risk indicators (KRIs) are metrics designed to identify risks of specific interest to study teams...

Source: Applied Clinical Trials

RBQM: A Natural Evolution to Achieve Gold Standard Clinical Trial Management (Pages 38-39)

The success of clinical development programmes, drug approval and marketing depends ultimately on the readability and...

Source: International Clinical Trials

Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes

Central monitoring, which typically includes the use of key risk indicators (KRIs), aims at improving the...

Source: Springer Link