Category: White Papers

Rescue-Cover-Update

Rescue Is Not A Dirty Word: 3 Measures to Overcome Operational Failures

‘Rescue’ Is Not A Dirty Word: Embracing Early Intervention in Faltering Clinical Trials Every year, tens of thousands of clinical trials are initiated. Every year, thousands of those trials falter, and, if corrective action isn’t taken, some may fail to produce usable data. In an analysis conducted by the Biorasi …

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How Virtual Trials Support Patient-Centricity

Revolutionizing Clinical Research: How Virtual Trials Support Patient-Centricity In this digital age, virtual trials may very well become the norm at some point in the future, but there are many questions to answer before this can become a reality. Download White Paper

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Advanced Analytics for the Monitoring of Clinical Trials

Advanced Analytics for the Monitoring of Clinical Trials What if there was a way to harness all this data we’re collecting and turn it into a strategic advantage for our clinical trials? Indeed, Biorasi’s data sciences team has found a way. Methods beyond risk-based monitoring are required for a more …

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Quintessential Guide to Planning a Clinical Trial

The Quintessential Guide to Planning a Clinical Trial Clinical trials are complex undertakings, with complex planning required. Success or failure is often determined long before the trial even gets underway. Biorasi’s quintessential guide to clinical trial planning helps program managers and operations directors identify and resolve the sticking points that …

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Putting CDISC Standards to Work

White Paper – Putting CDISC Standards to Work

Putting CDISC Standards to Work The CDISC set of standards revolutionized data management in clinical trials by introducing a standardized model for data interoperability. The standard has been shown to decrease study data resource requirements by 60% overall, and 70-90% in start-up stages when implemented early. This results in dramatic …

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Operating a Pharmacovigilance Group in a Multicultural Global Environment

White Paper – Operating a Pharmacovigilance Group in a Multicultural Global Environment

Operating a Pharmacovigilance Group in a Multicultural Global Environment The way an individual interprets language is influenced by many factors, including culture, background, education, training, and personal biases. Download White Paper

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White Paper – Optimizing Ophthalmic CE ANDA Trials

Optimizing Ophthalmic CE ANDA Trials Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper

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Navigating through the Clinical Trial Authorization Process in Russia

White Paper – Navigating through the Clinical Trial Authorization Process in Russia

Navigating through the Clinical Trial Authorization Process in Russia Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper

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Patient Numbers Required In Clinical Endpoint ANDA Trials

White Paper – Patient Numbers Required In Clinical Endpoint ANDA Trials

Patient Numbers Required In Clinical Endpoint ANDA Trials Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper

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Optimizing the Amount of Investigational Materials PART TWO

White Paper – Optimizing the Amount of Investigational Materials in ANDA Studies – Part Two

Optimizing the Amount of Investigational Materials in ANDA Studies – Part Two For Dermal Semisolid Clinical Studies White Paper Series Download White Paper

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Optimizing the Amount of Investigational Materials PART ONE

White Paper – Optimizing the Amount of Investigational Materials in ANDA Studies – Part One

Optimizing the Amount of Investigational Materials in ANDA Studies – Part One Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper

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Clinical Endpoint ANDA Program Optimization

White Paper – Clinical Endpoint ANDA Program Optimization Introduction

Clinical Endpoint ANDA Program Optimization This introduction marks the launch of a series of White Papers dealing with the optimization of Clinical Endpoint ANDA Programs for the generics and specialty pharmaceutical industry. We will be publishing these reports addressing and analyzing different aspects of optimization several times a year and …

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