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Volume 16 Issue 3
 
 
Fostering Communications in the Drug Development Process
Volume 10 Issue 1

Fostering Communications in the Drug Development Process

In this article, Deborah A. Komlos at Clarivate Analytics describes the high importance of the communications between sponsors and the US Food and Drug Administration...
8 February 2018 Volume 10 Issue 1
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Is AI the Key to Unlocking Regulatory Complexity in Life Sciences?
Volume 10 Issue 1

Is AI the Key to Unlocking Regulatory Complexity in Life Sciences?

Navigating the ever-growing regulatory and compliance complexity in life sciences is a challenge that most in the industry struggle with at times. Yet there are ways ...
8 February 2018 Volume 10 Issue 1
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How Real World Evidence Can Ease Payers’ Anxieties About Orphan Drugs
Volume 10 Issue 1

How Real World Evidence Can Ease Payers’ Anxieties About Orphan Drugs

In recent years, health insurers have argued that the high price tags on drugs for rare diseases are unsustainable. For America’s Health Insurance Plans (AHIP), an in...
8 February 2018 Volume 10 Issue 1
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Strengthening the Links Across the Clinical Trial Supply Chain: A Collaborative Meeting
Volume 10 Issue 1

Strengthening the Links Across the Clinical Trial Supply Chain: A Collaborative Meeting

Successful delivery of clinical trials depends on many factors, not the least of which is having an effective clinical trial supply chain for investigational products...
8 February 2018 Volume 10 Issue 1
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Powering Clinical Trials: Achieving Relevance
Volume 10 Issue 1

Powering Clinical Trials: Achieving Relevance

Enrolling insufficient numbers of subjects to power a clinical study is often cited as a major reason for failure to achieve statistically significant endpoint or hig...
8 February 2018 Volume 10 Issue 1
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Life Sciences Industry Moves to Unify Clinical Operations
Volume 10 Issue 1

Life Sciences Industry Moves to Unify Clinical Operations

With the growing number of clinical trials and increased complexity across the clinical lifecycle, life sciences organisations are under more pressure than ever to im...
8 February 2018 Volume 10 Issue 1
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The Changing Face of Pharmacovigilance
Volume 10 Issue 1

The Changing Face of Pharmacovigilance

From heightened demands by regulatory authorities for contextual demonstration of the benefits and risks of a drug, to the need for pharmacovigilance to play a more s...
8 February 2018 Volume 10 Issue 1
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The Bigger Picture of ICH E6 R2: Looking Beyond Compliance
Volume 10 Issue 1

The Bigger Picture of ICH E6 R2: Looking Beyond Compliance

The introduction of ICH E6 (R2) this past year has rendered the implementation of risk-based monitoring principles a matter of GCP compliance. While clinical research...
8 February 2018 Volume 10 Issue 1
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Insurance Best Practices for Human Clinical Trials
Volume 10 Issue 1

Insurance Best Practices for Human Clinical Trials

Sandrine Bresard and Frederic Nouaille at i4CT analyse how important insurance is in clinical trials and how local requirements are very different, depending on the c...
8 February 2018 Volume 10 Issue 1
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Gene Therapy Products for Life-Threatening Diseases are getting the Green Light
Volume 10 Issue 1

Gene Therapy Products for Life-Threatening Diseases are getting the Green Light

Through this article, Jaime Polychrones at Clarivate Analytics draws attention to the memorable 2017, when the US Food and Drug Administration (FDA), for the first ti...
8 February 2018 Volume 10 Issue 1
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