Authors


Olive McCormick

Latest:

Why Data Integrity Should be an Integral Part of the Pharma Biotech Industry Culture

Data integrity is the essence of GMP, the cornerstone of how the industry operates, and it is vital that all organizations embrace it to survive the rapidly changing life sciences landscape.


Grace Maria Antony

Latest:

Categorical Data Analysis

A review of different statistical methods for data types and models used during research.


Norafizaa Yusop

Latest:

Evolution of Clinical Trial Agreement Review in Malaysia Through Clinical Research Malaysia

A reduction of Clinical Trial Agreement Review times has caused rapid development in Malaysian clinical trials.


Nurul Atiqah Abd Rahman

Latest:

Evolution of Clinical Trial Agreement Review in Malaysia Through Clinical Research Malaysia

A reduction of Clinical Trial Agreement Review times has caused rapid development in Malaysian clinical trials.


YPrime

Latest:

Advancing Oncology Drug Development with ePRO Solutions

For drug developers, oncology therapeutics arguably represent both the greatest opportunity and challenge for putting patients at the center. This ebook covers series strategies for Advancing Oncology Drug Development with ePRO Solutions.


Jessica Rine

Latest:

How Data and Analytics Can Improve Clinical Trial Feasibility

These seven key building blocks for success are outlined to help companies develop and implement a data-and-analytics-driven approach to clinical trial feasibility.


Sharma Ramanathan Deva Devesa

Latest:

4 Key Actions ClinOps Can Take Now to Avoid Disruptions

Biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.


Indu Menon

Latest:

Medical Coding Procedures in Clinical Research: An Amarex Safety and Pharmacovigilance Perspective

This article will detail how the Amarex Safety & Pharmacovigilance team performs medical coding using an internally developed safety platform.


Nkem Olanrewaju

Latest:

Medical Coding Procedures in Clinical Research: An Amarex Safety and Pharmacovigilance Perspective

This article will detail how the Amarex Safety & Pharmacovigilance team performs medical coding using an internally developed safety platform.


Kunal Naik

Latest:

Medical Coding Procedures in Clinical Research: An Amarex Safety and Pharmacovigilance Perspective

This article will detail how the Amarex Safety & Pharmacovigilance team performs medical coding using an internally developed safety platform.


Shide Badri

Latest:

Medical Coding Procedures in Clinical Research: An Amarex Safety and Pharmacovigilance Perspective

This article will detail how the Amarex Safety & Pharmacovigilance team performs medical coding using an internally developed safety platform.


Ugo Benson-Nwoji

Latest:

Medical Coding Procedures in Clinical Research: An Amarex Safety and Pharmacovigilance Perspective

This article will detail how the Amarex Safety & Pharmacovigilance team performs medical coding using an internally developed safety platform.


Penelope Manasco M.D.

Latest:

Comparing Risk Based Monitoring and Remote Trial Management vs. SDV

A new RBM method used in PaxVax trial proves successful vs. onsite source data verification for trial oversight.


Michelle Pallas

Latest:

Comparing Risk Based Monitoring and Remote Trial Management vs. SDV

A new RBM method used in PaxVax trial proves successful vs. onsite source data verification for trial oversight.


Lisa Danzig M.D.

Latest:

Comparing Risk Based Monitoring and Remote Trial Management vs. SDV

A new RBM method used in PaxVax trial proves successful vs. onsite source data verification for trial oversight.


Charlene Kimmel

Latest:

Risk-Based Monitoring Versus Source Data Verification

Pilot study compares a risk-based monitoring and remote trial management method with traditional on-site source data verification for trial oversight.


Sean Bennett M.D., Ph.D.

Latest:

Comparing Risk Based Monitoring and Remote Trial Management vs. SDV

A new RBM method used in PaxVax trial proves successful vs. onsite source data verification for trial oversight.


Garrett Manasco

Latest:

Comparing Risk Based Monitoring and Remote Trial Management vs. SDV

A new RBM method used in PaxVax trial proves successful vs. onsite source data verification for trial oversight.


Deborah Thompson MPH

Latest:

Comparing Risk Based Monitoring and Remote Trial Management vs. SDV

A new RBM method used in PaxVax trial proves successful vs. onsite source data verification for trial oversight.


Lisa Bedell MA

Latest:

Comparing Risk Based Monitoring and Remote Trial Management vs. SDV

A new RBM method used in PaxVax trial proves successful vs. onsite source data verification for trial oversight.


Everett Lambeth

Latest:

Risk-Based Monitoring Versus Source Data Verification

Pilot study compares a risk-based monitoring and remote trial management method with traditional on-site source data verification for trial oversight.


Kevin Fielman Ph.D.

Latest:

Comparing Risk Based Monitoring and Remote Trial Management vs. SDV

A new RBM method used in PaxVax trial proves successful vs. onsite source data verification for trial oversight.


ICON

Latest:

The Evolving Relationship Between Sponsors and Contract Research Organizations

If the last few years have taught us anything, it’s that so much more can be achieved when all players in the life sciences and pharmaceutical industries work together in a truly collaborative way. The opportunity for the clinical development industry is to take what we have learned about how we can work together and use this to continue to drive progress. To strategically support clients, at ICON, this means partnering with sponsors in a way that goes beyond a traditional CRO. It means being a trusted partner.


Betsy Fields Smith

Latest:

Human Centered Design—A Pathway to Patient Centricity

uMotif worked with IDEO to shape a patient-centric approach by focusing on human-centered design.


Bruce Hellman

Latest:

Patient Centricity: The Journey Matters

Five proactive steps industry can take to optimize a patient's clinical trial experience.


Sebastian Turek

Latest:

Alzheimer’s Clinical Trials: Obstacles and Opportunities

For sponsors who are pursuing the goal of treating Alzheimer’s disease, understanding the obstacles inherent in Alzheimer’s clinical trials can help in planning for, and overcoming, these challenges.


Jason Birri

Latest:

A Roadmap to Phase I Challenges for Cell and Gene Therapy Products

Cell and gene therapies are the latest wave of advanced technologies that will shape the face of the modern-day biopharma arena, enabling a path to pinpoint a faulty gene or cellular mechanism at the root of a specific disease.


Nicole Gallo

Latest:

A Roadmap to Phase I Challenges for Cell and Gene Therapy Products

Cell and gene therapies are the latest wave of advanced technologies that will shape the face of the modern-day biopharma arena, enabling a path to pinpoint a faulty gene or cellular mechanism at the root of a specific disease.


Chris Kelly

Latest:

A Roadmap to Phase I Challenges for Cell and Gene Therapy Products

Cell and gene therapies are the latest wave of advanced technologies that will shape the face of the modern-day biopharma arena, enabling a path to pinpoint a faulty gene or cellular mechanism at the root of a specific disease.


Julie Kristen Hagan

Latest:

A Roadmap to Phase I Challenges for Cell and Gene Therapy Products

Cell and gene therapies are the latest wave of advanced technologies that will shape the face of the modern-day biopharma arena, enabling a path to pinpoint a faulty gene or cellular mechanism at the root of a specific disease.

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