Highlights from the PhUSE EU Connect

Creating a Common Language: Forging Statistical and Clinical Collaborations

The Good Data Submission Doctor: 5 Top ADaM Frequently Asked Questions

Can Statisticians Contribute to Enhance the Position of Patients in Clinical Trials?

Webinar: Basket Trial Design and Implementation Considerations

Data Management Fundamentals for Your Next Clinical Trial

New publication addresses critical issues in ultra-orphan indications

The Good Data Submission Doctor: 5 Top SDTM Frequently Asked Questions

Incorporating patient preferences and values into risk-benefit calculations opens new horizons

Career Perspectives: Interview with Munshi Imran Hossain, Senior Data Scientist

Selection Bias for Treatments with Positive Phase 2 Results with Simon Kirby

Highlights from the SCDM 2018 Conference

When Knowledge Drives Results: The Impact of a Winning Data Strategy

Interview with Stephen Senn: 70 Years and Still Here: The Randomized Clinical Trial and its Critics

The "Master Recipe": Quality and Attention to Details Matter When Submitting CDISC Packages to Authorities

Decision Making in Development Programs with Targeted Therapies: with Heiko Götte

Career Perspectives: Interview with Adam Hamm, Director of Biostatistics

Novel immunotherapies lean on old methods (or how to teach your dragon old tricks)

Could data science be about to revolutionize the regulatory approval of new drugs?

Opportunities of FDA’s Complex Innovative Trial Design Pilot Meeting Program

Podcast: Enhancing Patient Enrollment Forecasting with EnForeSys 2.0

Highlights from the JSM 2018 Conference

Career Perspectives: Interview with Meredith Alm, Manager, QA Compliance

How Does a CRO Programming Career Stack Up?

2018 East User Group Meeting Addresses Multiplicity Themes, with keynotes including Stephen Senn and Meinhard Keiser.

How can a strategic pharmacometrics consultant add value to your team?

Building interactive web applications using R Shiny

Infographic: 5 Key Interactions of Data Management and Statistics

Career Perspectives: Interview with Sam Hsiao, Associate Director, Strategic Consulting

Recent Publication: On shapes of ADR report accumulation data

Case Study:Creating an Effective Functional Services Partnership

Unveiling New East 6.5 Modules: Join Our Webinar

Highlights from the PSI 2018 Conference

Measuring lots of little details: Non-Compartmental Analysis and the Early Phase Regulatory Environment.

The Importance of Standardization in Clinical Outsourcing

What makes a good data manager?

Career Perspectives: Interview with Andrea Hita, Biomedical Data Scientist

5 Reasons to Integrate Model-Based Meta-Analyses (MBMA) Into Your Clinical Development Strategy

Addressing Critical Unmet Oncology Needs in the Era of Precision Medicine

Exploring Differences Between Pinnacle 21 Community and Enterprise versions for CDISC Compliance

Rewriting the oncology textbook with cell-based immunotherapies

Innovative Oncology Trial Designs in Practice

Breaking Boundaries in Drug Development at PSI

Career Perspectives: Interview with Omar Sefiani, Principal Statistical Programmer

Infographic: Overcoming Data Management Challenges in Immuno-Oncology Trials

Developing the Next Generation of Skills for Statistical Programmers

Interview with Ken Getz: Exploring Challenges of Clinical Trial Operations Part 2

Interview with Ken Getz: Exploring Challenges of Clinical Trial Operations Part 1

Maximizing Preclinical Knowledge for Optimal R&D

Clinical Biometrics Survey Reveals Industry Challenges and Trends

A Year in the Life of a Software Trainer

Case Study: CliPLab Develops and Implements a Clinical SAS Intensive Training

Career Perspectives: Interview with Benjamin Esterni, Principal Biostatistician

What makes a Successful FSP Partnership Tick?

Creating an R-Package Template: A Guide

Best Sample Size Calculators for iPhone

Interview: Insight into the Coordination of Rare Diseases at Sanford (CoRDS) registry 

Cytel Congratulates Lipopharma and CLINGLIO Consortium on Recent Grant Award

Developing efficient tools for ADaM dataset creation

Recent Publication: A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group Sequential Design with Multiple Interim Looks

Career Perspectives: Interview with Ursula Garczarek, Associate Director - Strategic Consulting

Life in Programming: Interview With Ajay Sathe

6 Innovative Trial Design Videos

Interview: Promoting precision medicine using data science 

Addressing the Problem of Feature Selection Using Genetic Algorithms

Career Perspectives: Interview with Lisa Goldberg, Associate Director of Statistical Programming

How Can We Tackle Heterogeneity in Meta-Analysis?

Round-Up:The 6 Hottest Blog Topics from 2017

Providing Evidence that Pollution Accelerates Skin Aging in Fast Moving Consumer Goods Trial

Signal Management Using R

Slides: East User Group Meeting and Trial Design Symposium

Interview: Clinical Trial Optimization with R

Career Perspectives: Interview with Makarand Deshmukh, Senior Clinical Data Analyst

Highlights from PhUSE 2017

Creating Efficiencies in the Vendor Qualification Process: A Proposal

The Cytel Story: In the Co-Founders' Own Words

Asking the Right Questions of Your Data: Experiences in Model Informed Drug Development

Innovative posters unveiled at ACoP8

Webinar Replay: Dual Target Methods for Go/No-Go Decision Making

Design Concept for Confirmatory Basket Trial Interview with Bob Beckman: Part 2

2017 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop

Webinar Replay: Phase 2 Trial Designs using Program-level Simulations

Highlights from the 2017 SCDM Program

Career Perspectives: Interview with Namrata Deshpande, Senior Team Lead

Case Study: Accurate Event Prediction in a Cardiovascular Outcomes Research Trial

How to handle conservativeness of Exact p-value?

How can Novel Statistical Methods Tackle Antibiotic Resistance? Interview with Scott Evans

Design Concept for Basket Trials: Interview with Bob Beckman

Removing 'Noise' from Biomedical Signals

Highlights from the 2017 JSM Program

4 Questions to Explore in Model-Informed Drug Development (Infographic)

Case Study: Cross-study Efficiencies in Biometrics Outsourcing

Are Adaptive Designs the Answer to Oncology Development Success?

Don’t miss these 5 session picks at JSM

Case Study: Seamless Independent Data Monitoring Committee Support

Creating Data Visualizations with R and Shiny

Collaboration Brings Success for the UK Adaptive Designs Working Group.

When Biostatisticians Disagree About Ethics

Under wraps: the importance of patient privacy

Join us for the East Symposium and User Group Meeting

Cytel ASCO 2017 Report

Poster: Model Based Predictions of Pharmacodynamic Responses in Ulcerative Colitis Patients

Measuring Intergroup Agreement and Disagreement

Highlights from the PSI 2017 Conference

Interview: How can a Bayesian framework support benefit risk assessment?

Cytel statistical programmer gains recognition at PharmaSUG 2017

Jim Bolognese named 2017 American Statistical Association Fellow

Case Study: From Trial Design to CDISC Submission

The Insider View: PSI 2017 Conference Preview

In the Midst of this: The Data Management Perspective on the Interim Analysis

Case Study: Redesigning a Pragmatic Trial in Oncology

Critical Operational Considerations for Interim Analyses

Trends in Model-Informed Drug Development: Our ASCPT Takeaways

FDA 22 Case Studies and Mitigating Phase 3 Risks

Better Management and Outputs in Statistical Programming

New Publication: Design and Monitoring of Multi-Arm Multi-Stage Clinical Trials

Case Study: Improving Go/No-go Decision-Making with Custom Software

Setting the Right Foundations: The Role of the Independent Randomization Center

The Data Management Plan Takes Center Stage- why is it so important?

Flexible approaches to Biosimilars Development

Case Study: Bayesian Decision-Making in a Phase 3 Oncology Design

Estimands 101: Interview with Mouna Akacha

Syntax and Variables in R: A Primer

Outsourcing success for emerging biopharma

Inside an Oncology Statistician's Toolkit

The Making of a CDISC Trainer

Accelerating development with combined SAD/MAD approach

How to get the regulatory green light for your adaptive design?

Data Structures in R: A Primer

Adaptive Design Approaches from Cardiovascular Clinical Trialists Forum

SAS and NONMEM - a marriage made in heaven?

Our readers' choice : Top Blog posts from 2016

CDISC submissions- are you up to speed?

How do CDASH standards build data quality?

Adaptive Design CONSORT Extension Project: The Inside Scoop

Harnessing the power of R API to extend software applications

Ensuring quality data no matter the phase: data management considerations

Innovative Phase 3 Adaptive Enrichment Design in Oncology

Infographic: 10 steps to consider before choosing an adaptive design

Case Study: Dose-response modeling informs Phase 2 ulcerative colitis study design

Infographic: 9 Do's and Don'ts to Ensure Independence of QC in Statistical Programming

How to ensure independence of QC in statistical programming 

New East Insights Video:Creating an SSR Design

Pharmacometrics tools of the trade: 4 factors to consider

R Beyond Statistics

Cytel Infographic: 6 Hot Topics from PhUSE 2016

The evolving role of the modern statistical programmer

Simulations to optimize clinical trial programs

Adaptive Designs: A Data Management Perspective

Challenges in Neuroscience Clinical Trials

Case studies:Learning from less-well understood adaptive designs

Practical Challenges of the LUNG-MAP study

An efficient tool for model based meta-analysis

Case Study:Exposure Response Modeling in Hematology

Case Study:Seamless Phase 2/3 Design in Rare Disease

Overcoming challenges of 'Less Well Understood' Adaptive Designs

Case Study: BLRM for Phase 1/2a Oncology Study

An Introduction to BLRM

Unblinded Sample Size Re-Estimation in Bioequivalence Trials with Small Samples

How does the T-Statistic stack up for finding MTD?

Adaptive Designs: In Conversation with the NEJM

Operational and regulatory considerations in a promising zone trial

The CRO role in Data Standards Governance

6 steps to timely database lock

5 trends a statistical programmer needs to follow

Webinar Replay: Single and Double Agent Dose Escalation Designs

5 session picks for the JSM

Adaptive Design in the limelight with NEJM article

Key considerations in selecting an EDC system

Wild Horses: How StatXact is helping conservation project in Mongolia

PROC MCPMod in Bronchodilator Case Study

The Rise of R-should SAS programmers get up to speed?

Getting the best out of your biometrics RFP

Sharpening your Advanced SAS Skills: Interview with Sunil Gupta

Determining the future course of your trial

Managing DMC analysis- an innovative programming solution

How can the CMO/Biostatistician connection improve clinical development?

EAST 6.4 Release: Interview with Yannis Jemiai

Highlights from the PSI Conference

Pattern Recognition and 'Big Data'

Scrambled Data – A Population PK/PD Programming Solution

Lost in Traceability- From SDTM to ADaM

Subgroup Analyses in Early Phase Clinical Trials

5 Hot Topics from the CDISC EU Interchange

Adaptive Designs in Practice

Overcoming Data Management Challenges in Oncology Studies

Dual Agent Dose Escalation Designs

Handling CDM data integrations

5 Key Interactions of Clinical DM and Statistics

HTAs: Adjusting Overall Survival for Treatment Switch

Blinded SSR in early phase biosimilar studies

What's the price of pharma innovation?

Decision Making in Early Clinical Development

What's the Value of P?

EAST takes on Multi-Arm Multi-Stage Designs

Mind the Gap! How to prepare for SDTM migrations.

Adaptive SSR: Debunking the inefficiency myth

Getting Technical: The evolving role of the Data Manager

EnForeSys® enrollment forecasting showcases at SCOPE

"Data Standards and My Experience" - Reflections from Sangeetha Gandepalli

How to Make the Most of Data Management Capabilities for Improved Risk Based Monitoring

A Competitive Alternative to Model-Based Dose-finding

Takeda Pharmaceuticals' Ling Wang Talks Model-based Dose-finding Designs

2 Talks on Early Phase Go/No-GO Decision Making

Bayesian Dose Escalation Designs for Late Onset Toxicity

The 24 Hour Work Day

Quantitative Pharmacology & Pharmacometrics for Biomarker Driven Clinical Strategy

How to Reduce Bias in the Estimates of Count Data Regression

P-Values & Pharma Development: We Want to Hear from You

Cytel Case Study Series III: Dose Finding & Dose Response Modeling in Pediatric Asthma

3 Statistical Challenges for Pooling Phase 1 Data

MCPMod: An Introduction

Statistical Primer for Cardiovascular Research

Being a Statistician: An Art, a Science or Just Job?

2 Methods for Evaluating Biomarker Subpopulations in (Adaptive Enrichment) Time to Event Trials

It’s Time to Bridge the Gap Between Pharmacometrics and Biostats

5 Skills Needed by All Highly Effective Statisticians

Virtual Teams and Clinical Data Management

Inference on Confidence Intervals for Adaptive Designs: The Latest Breed of Adaptive Clinical Trials

Cytel Case Study Series II: Adaptive Bayesian Design with Informative Prior

Cytel Case Studies Series #1: Using Simulation for Accelerated Early Phase Drug Development

Modern Early Phase Clinical Trial Design Primer

Do you really need a full service CRO? An exploration of strategic options

Mitigate Phase 3 Clinical Trial Risk by Optimizing Phase 2 Data

Evidence Based Medicine: 25 Years Later

MCP-Mod for the Modern Dose-Ranging Clinical Trial

Why and When to Use Profile Likelihood Based Confidence Intervals

Special Update: US House of Representatives Passes 21st Century Cures Act

3 Questions to Ask About Your Trial's Enrollment

Why You Should Not Power for Superiority Upfront: Promising Zone Clinical Trials with "Adaptive Switch"

3 Strategies to Combat Inferential Conservatism in Small Sample Sizes

A Cautionary Tale about Composite Endpoint Construction: The ARISE Trial

Aligning Clinical Development & Regulatory Objectives for Cardiovascular Outcome Trials

Building Teams to Handle Unexpected Regulatory Agency Requests

Patient Recruitment Feasibility: Would you bet $12 million dollars on it?

How to Use Outsourcing to Reduce Clinical Development Risk

Seamless Adaptive Clinical Trials: Now that we get the statistics, what’s really at stake?

Regulation and Reproducibility: Can You Reproduce Your Clinical Trial Results?

‘A blend of courage and foolhardiness’: Marvin Zelen's 8 Predictions for the Future of Biostatistical Sciences

New Articles on Adaptive Clinical Trials & Adaptive Financing

Dose-finding with Sequential Parallel Comparison Designs

Adaptive SSR for Small Sample Sizes?

Phase 2 Designs for Clinical Utility Limiting Therapies

New Cytel Whitepaper: Monte Carlo Simulations for Patient Recruitment

Relative Clinical Efficiency and Phase 2 Biomarker Studies

Monte Carlo Simulations II: Reassessing Strategic Options During an Interim Look

Leveraging the Flexibility of an Adaptive Clinical Trials: A Case Study

Statistical and Operational Challenges of the VALOR Trial: Mehta on the Promising Zone

How Bayesian Strategies Can Expedite a Pediatric Clincial Trial Time by 20 - 40%

How to Plan Interim Looks in Adaptive Clinical Trials: 3 Strategies

Monte Carlo Simulations for Patient Enrollment: A Presentation by the Director of Pfizer's Feasibility Center for Excellence

Embracing the Adaptive Mindset

Adaptive vs. Group Sequential Designs in Survival Analysis

Successful Adaptive Confirmatory Dose-Response Pediatric Study

How Proposed Regulatory Reforms Will Affect Your Clinical Trial

Data-Driven Trial Planning: An Interview with Pfizer's Chris Conklin

How to Shorten a Cardiovascular Outcome Trial By Two Years

3 Key Trends in Clinical Trial Enrollment Forecasting

Clinical Development & Statistical Methodology for Cardiovascular Risk Assessment

Adaptive Design and Bayesian Statistics: 5 Years Later (Podcast)

How to Take Control of Your Enrollment Woes

Adaptive Clinical Trial Strategies for the Limited Early Phase Budget

Why Drugs Fail in Phase 3: A Cytel Infographic

Old and New Drug Development Paradigms: Cytel Infographic

Simulation and Prediction for Adaptive Licensing Decision-Making

Our Readers Choice: Top 10 Posts from 2014

Clinical Drug Development: Predictions & Trends for 2015

Early Phase Development Strategy: Bayesian Methods for Go/No-Go Rules

Cultivating Versatility in Statistical Consultants

Adaptive Designs for Infectious Diseases Clinical Development Strategy

Drug Supply Planning for Dose-Ranging Adaptive Trials

Operationally Seamless & Inferentially Seamless Adaptive Designs

How to Incorporate New Technology into Your Clinical Development Strategy

A Bayesian Industry Approach to Phase I Combination Trials in Oncology

Remembering Marvin Zelen

Ranking Adaptive Dose-Finding Designs using Clinical Utility Functions

Translational Statistics: How to Move Beyond the Comfort Zone

New Exploratory Trial Method Translates into Better Financial Strategy

Michael Proschan on 'Blinded Adaptations, Permutations and t-tests' (Link to Slides)

Adaptive Dose Finding Using Toxicity Probability Intervals

Clinical Impact Beyond 'Time to First' Analyses

7 Reasons to Add a Statistical Consultant to Your Team

You Own This!

Bayesian-Bandit Adaptive Designs for Rare Disease Drug Development

Statisticians on Software Development Part II: The Philosophy Behind a Software Package

Adaptive Clinical Trials: Your Questions Answered

5 Scenarios When ‘Keep it Simple’ May Be Bad Advice for Clinical Trial Designers

FDA Industry Session Features Panel on "Seamless Adaptive Designs"

Empirical Study Confirms Positive Impact of Adaptive Designs

FDA-Industry Session on Cardiovascular Outcome Trials: Mehta on EXAMINE Trial’s Promising Zone Design

Adaptive Designs for Evidence Based Oncology: Insights from the Experts

Impact of Study Design and Development Strategy on Pharmaceutical Programs and Portfolios

Why adaptive sample size re-estimation designs preserve type 1 error

Statisticians on Software Development Part I: Statisticians from Cytel, SAS and Stata talk Software Development

Bayesian Trial Designs are Safe, Efficient & Flexible: A Review of Published Phase 1 Studies

New ISCB Course on Adaptive Design

Backward Image Confidence Intervals for Adaptive Group Sequential Designs (Full Article Attached)

What Horsepower Can Teach us about Well-Powered Trials

The Rev Bayes Parties with Cytel at JSM 2014

Reflections on Statistical Entrepreneurship: An Interview with Nitin Patel

Bayesian Approaches in Clinical Trials: Updates on Tools & Techniques

Why Using Adaptive Designs Can Attract Investors to Your Trial

Data Management and Biostatistics III: Statistical Innovation in Clinical Data Management

To Adapt or Not to Adapt? 10 Simple Steps to Deciding Whether Your Next Trial Should be Adaptive

Predicted Interval Plots: A General Overview

Cytel Animation: Modern Dose Escalation Phase 1 Trials

Congratulations Germany!

Mehta Publishes Article on Adaptive Designs for Biomarker Driven Population Enrichment in Oncology

5 Reasons to Invest in Adaptive Designs for Population Enrichment

'Multivariate Approaches for Risk-Based Monitoring' An Adaptive Design (Slides Attached)

Adaptive Designs for Precision Medicine: A Look at Pfizer's Xalkori Trial (Slides Attached)

Overcoming Prowell's Pitfalls: Cytel Weighs in on Strategies for Oncology Development

Powering Oncology Trials for Success: Adaptive Designs in East

Data Management & Biostatistics II: Operational Benefits of Bundling

2014 Zelen Award Honors Statistician and Educator

Cytel's CliPLab: Training the Next Generation of Clinical Programmers

Data Management & Biostatistics I: Improving Trial Quality

Frequentist? Time for an update!

Cytel Joins DIA Discussion on Predictive Enrichment Strategies

De-Risking Drug Development using Adaptive Design

5 Reasons to Invest in Bayesian Dose-Escalation Methods

The Perils of Poor Recruitment

StatXact 25th Anniversary: Reflections of a Pioneer

New JAMA Study Confirms Importance of Trial Design for FDA Approval

StatXact 25th Anniversary: A Horizon for the Stars

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