Month: July 2017

Psoriasis_120928069

A Modern Approach to Patient education Increases Enrollment

A Modern Approach to Patient Education Increases Enrollment Interactive Solution Increases Enrollment And Compliance With Injectables Download Case Study The Challenge:Running a trial for dermatology injectables when topical alternatives exist presents unique challenges. Patients are reluctant to stick themselves regularly for what they perceive as marginal improvements over an alternative …

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Traial Planning Save ALBP Trial some Pain

Biorasi Rescue Effort Doubles CNS Trial Enrollment Rate Leveraging experience to predict problems before they affect clinical trial deliverables Download Case Study The Challenge:Not every study presents a completely new and unique set of challenges. That’s not to say that the trial is generic, or not complex, but rather that …

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Bipolar_84309564

Biorasi’s TALOS™ Platform and Unique Sites Win Unusual ANDA Trial

Biorasi’s TALOS™ Platform and Unique Site Win Unusual ANDA Trial Flexibility and Strong Process-driven Planning Overcomes Regulatory Speedbumps Download Case Study The Background:ANDA approval for therapies going off-patent are typically a staid affair. Timelines are established years in advance, procedures are standardized and well-tested, sites and patients are largely uniform …

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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 Covers6

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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blog-post-5-signs-rescue

Five Signs Your Clinical Trial Needs a Rescue

By some estimates, more than 90% of drug candidates never make it into consumer hands. That number shouldn’t come as a surprise to anyone who has spent time in pharma R&D, but thankfully most of those failed compounds fail early and relatively cheaply. What’s more surprising, though, is that a …

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