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Volume 16 Issue 3
 
 
Central Risk-based Monitoring Supports Reduced Cost and Higher Levels of Data Quality
Volume 12 Issue 2

Central Risk-based Monitoring Supports Reduced Cost and Higher Levels of Data Quality

Good Clinical Practice (GCP) focuses on data quality and integrity. Clinical trial sponsors must demonstrate strict oversight of studies to ensure proper conduct, sa...
17 April 2020 Volume 12 Issue 2
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Industry Drive to Improve Information Exchange and Speed Study Start-up
Volume 12 Issue 2

Industry Drive to Improve Information Exchange and Speed Study Start-up

As life sciences companies take action to speed up study execution, there is a significant opportunity to make clinical research processes more efficient. Rik van Mo...
17 April 2020 Volume 12 Issue 2
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Building Bridges Towards Patient Clinical Studies: Critical Considerations in the Drug Development Process
Volume 12 Issue 2

Building Bridges Towards Patient Clinical Studies: Critical Considerations in the Drug Development Process

Early-phase clinical trials, known as human pharmacology studies, start principally with the aim of collecting information on the safety and tolerability of the drug...
17 April 2020 Volume 12 Issue 2
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Getting Your Bad News Early Will Ensure You Don’t Fail Tomorrow
Volume 12 Issue 2

Getting Your Bad News Early Will Ensure You Don’t Fail Tomorrow

It is extremely rare for CROs to move seamlessly through an entire clinical trial without encountering some problems or hurdles. But what you don’t want is a situati...
17 April 2020 Volume 12 Issue 2
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Regulatory Watch: Rare Disease Day
Volume 12 Issue 2

Regulatory Watch: Rare Disease Day

In February 2020, the thirteenth international Rare Disease Day was held, where hundreds of patient organisations from countries and regions all over the world organ...
17 April 2020 Volume 12 Issue 2
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FDA Focuses Efforts on Making Patient Perspectives Count
Volume 12 Issue 2

FDA Focuses Efforts on Making Patient Perspectives Count

During the last eight years, the US Food and Drug Administration (FDA) has been increasingly focused on realising a vision—to incorporate patient input in drug devel...
17 April 2020 Volume 12 Issue 2
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The Rise of Patient-centric Clinical Trials in Today’s Environment
Volume 12 Issue 2

The Rise of Patient-centric Clinical Trials in Today’s Environment

There is a growing movement within the industry to focus on patientcentricity in clinical trials. The FDA and EMA have introduced requirements to include patient inp...
17 April 2020 Volume 12 Issue 2
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Review Phase Assessment for ANDA Submission in US: A Regulatory Review
Volume 12 Issue 2

Review Phase Assessment for ANDA Submission in US: A Regulatory Review

Today, the vast majority of drugs available for patients in the United States are generics that have gone through a rigorous system of evaluation supervised by the U...
17 April 2020 Volume 12 Issue 2
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Establishing Clear Procedures and Improving Start-up Timeline in Malaysia’s Clinical Research Ecosystem
Volume 12 Issue 2

Establishing Clear Procedures and Improving Start-up Timeline in Malaysia’s Clinical Research Ecosystem

As delays in getting clinical trials up and running have financial implications, pharmaceutical companies and contract research organisations (CROs) are looking at w...
17 April 2020 Volume 12 Issue 2
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Patient-centricity on Trial
Volume 12 Issue 2

Patient-centricity on Trial

The pharmaceutical industry has a problem; clinical trials are failing to recruit and retain the required number of patients at an alarming rate. The statistics are ...
17 April 2020 Volume 12 Issue 2
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Journal For Clinical Studies has a distinguished editorial advisory board providing the best guidelines for global clinical trials. Your resource for Multisite Studies and emerging markets.

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