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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, a Leading Provider of AI-Driven Software Solutions for Clinical Data Review, Receives Significant Investment for Continued Growth from EQT
CluePoints is a cloud-based software platform for Risk-Based Quality Management (“RBQM”) and data quality...
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CluePoints Brand Evolution Confirms Commitment to 'Turning Artificial Intelligence into Human Intelligence'
KING OF PRUSSIA, Pa., — CluePoints, provider of leading statistical and AI-driven software solutions,...
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Quality Tolerance Limits: An Updated View of Industry Trends
We presented an initial review of quality tolerance limit (QTL) adoption trends in the March 2023 issue...
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FDA And CluePoints Sign New 3 Year Cooperative Research And Development Agreement To Assess Data Quality Using Statistical Modelling And Machine Learning
King of Prussia, PA: CluePoints, providers of leading statistical and AI-driven software solutions and...
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FDA and CluePoints Extend Existing Collaboration to Include AI/ML for Quality Assessment
Under the new extension, FDA and CluePoints will enhance CluePoints’ SMART software to address a broader...
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The Risk-Based Data Management (RBDM) Revolution
The clinical trials landscape is evolving with more data, increased investment in personalized medicines...
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RBQMLive, Sponsored by CluePoints, Wins Prestigious Sales and Marketing Award

King of Prussia, PA – August 9, 2023: CluePoints, the premier provider of Risk-Based Study Execution...

ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?

The ICH E6(R3) draft guideline document, currently open to public consultation, places the industry firmly in...

Source: Applied Clinical Trials

Expert Speaker Lineup Revealed for Award Winning RBQM Event

King of Prussia, PA – August 1, 2023: CluePoints, the premier provider of Risk-Based Quality Management...

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...

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

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...

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

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