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At Premier Research, we focus on doing what we do best: on helping highly innovative biopharmaceutical and medical device companies bring their life-changing developments from initial strategy through clinical development to market. To do that, we have developed a surprising concentration of experience for a mid-sized CRO…Learn More

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A regulatory overview of rare diseases and orphan drug status as well as practical considerations for varying stages of the development process. Learn about conducting successful Natural History studies and how to avoid common challenges through lessons learned.

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Rare Disease Trials: Beginning, Middle, and End

Webinar: Available for Download

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What if your product has the ability to achieve multiple indications in multiple therapeutic areas? How do you decide the best way to proceed in order to invest in the top opportunities with the highest return on investment?

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Strategies: Med Device + Diagnostic Organizations

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From the imperative to detect cognitive and functional changes as early as possible in the course of Alzheimer’s disease, through the importance of measuring cognitive and attentional effects of investigational drugs in clinical trials.

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Measuring Subjects in Neuropsychiatric Trials

Webinar: Available for Download

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Aspects of Clinical Development Related to ICH E11 Categories of Children. This webinar discusses the importance of considering differing ages/stages of children when designing/conducting trials (presented March 24, 2014)…Download Today!

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Aspects of Clinical Development Related to ICH E11

Webinar: Available for Download

Orphan Drug Congress Nov 2013: Part 5

Top Takeaway ​Tips From the Experts

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​This webinar reviews criteria for studies that are both scientifically rigorous while meeting the high ethical standards required of clinical trials in the vulnerable pediatric population (presented Nov 11, 2013)…Download Today!

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Pediatric Studies: Study Design and Considerations

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​Plain and simple, it takes experience. Hands-on experience with both the therapeutic area and the highly idiosyncratic world of orphan drug development. The kind of specialized experience you’ll find across the board at Premier Research. Because it’s what we do. Best.

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RareDiseases

Our Experience: Rare Disease

Meeting an Enormous Unmet Medical Need…

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​​If you’re looking for a career and not just a paycheck, you’ve come to the right place. Ready to be challenged?

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Career Opportunities

If you're looking for a career…

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Pediatric studies are substantively different from adult trials in terms of recruitment challenges, operational feasibilities and ethical considerations. Fundamentally, clinical trials in children should be designed for pediatric populations that, in contrast to adult patients…

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Pediatrics

Our Experience: Pediatrics

Extraordinary experience, insight and capability…

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​Tap into the knowledge of two seasoned drug developers from Premier Research for a webinar packed with practical, experience-based guidance. Learn about the hurdles to overcome when studying rare diseases (presented July 16, 2013)…Download Today! 

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Rare Disease and Orphan Drug Development in US

Webinar: Available for Download

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A biopharmaceutical company focused on the discovery and development of novel products to address unmet medical needs contracted with us to manage their 30-site, 212-patient doubleblind placebo controlled trial in patients with Eosinophilic Esophagitis (EE), an often undiagnosed illness.

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Case Study: Pediatrics

Managing trial in an orphan indication…

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​Learn about the hurdles to overcome when studying rare diseases and find out how to skillfully navigate the clinical and regulatory challenges on the path to successful orphan drug development in Europe (presented May 14, 2013)…Download Today!

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Rare Disease and Orphan Drug Development in Europe

Webinar: Available for Download

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Study Volunteers

Sign up Today!

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White Paper

Pediatric Studies Part 1

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Superior Management for Multinational Rare Disease

Premier Research is currently managing a multicenter, multinational, pediatric and adult rare disease program for an orphan drug used in the treatment of Alkaline Phosphatase Deficiency.

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Case Study: Rare Disease

Management for Multinational Rare Disease…

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Program Expansion through Successful Collaboration​

A small, US-based biotech company specializing in rare diseases contracted Premier Research to manage their global pediatric and adult Lipid Storage Disease program.

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Case Study: Rare Disease

Program Expansion through Successful Collaboration...

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White Paper

Pediatric Studies Part 2

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Our People

Ludo Reynders

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​This webinar explains the similarities and differences that exist for device and drug studies in the US and EU and nuances of study conduct (presented July 30, 2013)…Download Today!

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Med Device/Drug Research: Similarities/Differences

Webinar: Available for Download

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​Our approach is working proactively in cooperation with you in order to maximize your study goals. We can bring global services that combine the talent of a large group of research professionals in Clinical Trial Management, Biometrics and Regulatory to address your needs…

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MedicalDevice

Our Experience: Medical Device & Diagnostics

Helping customers bring medical devices to market...

​​One thousand people anticipating the unexpected. Global clinical research. It's what we do. Best.

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To meet our customers’ evolving needs, we are expanding our services and “dedicated to devices” staff, and we are moving forward under a new name: Premier Research Medical Device and Diagnostic Business Unit.

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Device and Diagnostic Development

The Next Step Forward

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Investigator Registration

Register for our database…

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One of the most difficult factors in recruiting patients is identifying and setting up sites for studies.

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Opinion Poll

New Rare Disease Survey…

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​Regulations require a continuous assessment of risk throughout the product’s life cycle, but you have to choose among the different kinds of studies, evaluate cost-benefit ratios and execute the studies as efficiently as possible (presented October 15th, 2013)…Download Today!

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Assessment of Medical Devices in Post-Market Phase

Webinar: Available for Download

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​A clinical trial is a research study in human volunteers to determine if new drugs or treatments are safe.

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What is a Study?

Benefit yourself and others…

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​With approximately 70 rare disease studies conducted in the past five years, across more than 30 indications and in multiple countries and languages, Premier Research has become the CRO of choice for sponsors.

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Orphan Drugs and Rare Diseases

Learn More About Orphan Drugs and Rare Diseases

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​Premier Research recently managed two Phase 2/3 Chronic Myeloid Leukemia trials for which we were recognized as the “Clinical Research Team of the Year” at the 2008 GCPj Awards.

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Case Study: Oncology

Managing high performance global project teams…

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Our People

Mark Sneff

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Areas where customers find our experience valuable:

Executing effective patient recruitment strategies

Optimizing the effectiveness of ePRO

Dealing with the complications of Class 2 drugs

Speeding up proof of concept studies

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Analgesia

Our Experience: Analgesia

Becoming the best at every aspect of analgesia…

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​For more than 30 years, Premier Research has been conducting clinical research studies to evaluate investigational medication in a variety of medical conditions. We have treated more than 90,000 study volunteers…

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Why Volunteer for Premier Research?

Commitment to provide excellent care to volunteers...

​​We worked on 600+ trials for virtually every major class of analgesic, enrolling 90,000+ patients. Learn More

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​We added four clinicians to key leadership roles in our pediatric and rare disease research disciplines.

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Staff Appointments

New People, Key Roles…

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​A large pharmaceutical company conducting a 260-patient study re-engineered their clinical development process to require a database lock within five days of the last patient visit, using only paper CRFs.

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Case Study: Biometrics

Beating the clock to database lock…

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​With a successful track record covering a wide spectrum of cancer-related therapeutic indications, we provide high quality full clinical research services from small dose finding and proof-of-concept studies to large, multi-national trials involving hundreds of patients in this area of research…

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Oncology

Our Experience: Hematology/Oncology

High quality full clinical research services…

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​As a preferred provider for a large pharmaceutical company, we provide a wide range of data management services including discrepancy management, EDC support, database programming, and randomization services, using the sponsor's data management system and processes.

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Case Study: Functional Sourcing

Dedicated resource outsourcing…

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​​Premier Research supported a device manufacturer from concept to market clearance in Europe for their novel device. This program began with our strategic consulting team, in collaboration with the client, developing the regulatory strategy during the early stages of product development.

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Case Study: Cardiovascular

Providing support from concept to market…

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​Premier Research has a long tradition in cardiovascular research for drugs and devices. The company was involved in the evolution of collection and monitoring of cardiotoxicity data for new molecular entities. Recently, we have supported the approval of many new devices…

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Cardiovascular

Our Experience: Cardiovascular

Experience and training in cardiovascular disease...

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Our People

Ajay Sadhwani

​Be part of the latest advances in healthcare. Join our clinical investigator database. Learn More

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​Neuroscience is one of the key therapeutic areas with continuing medical need and one with many compounds in the research pipeline. Our expertise is focused on bringing these compounds through the clinical development process as quickly and efficiently as possible…

Neuroscience

Our Experience: Neuroscience

Experience only a focused CRO can offer…

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​Providing additional experience in the following areas: 

1. Dermatology

2. Infectious Disease

3. Respiratory

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AdditionalAreas

Our Experience: Additional Areas

Extensive clinical experience in additional areas…

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Our Services

Biostatistics

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White Paper

Center of Excellence

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​We will conduct a phone screen in which we will ask you questions about your health and medical history. You can decline to answer or stop the interview process at any time…

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Study Volunteers: What Can I Expect?

To volunteer for a study, simply give us a call…

​Physicians—find out how to make clinical research part of your practice. Learn More

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White Paper

Optimizing Oncology Trials

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​We are currently enrolling volunteers into various studies in our Austin and Phoenix locations. If you are interested and have been thinking about volunteering for a study please be sure to view our list of current studies.

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Current Studies

To be considered for a study please contact us…

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​Following the successful completion of an open-label and Analog Classroom setting Phase 3 pediatric ADHD studies, a global specialty biopharmaceutical company contracted us to conduct a third ADHD study utilizing the Analog Classroom setting for a Workplace Environment Study. 

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Case Study: Neuroscience

Thorough training and experienced team…

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White Paper

REMS and Opioid Analgesics

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White Paper

Developing Analgesia Studies

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The company identified a problem with one of their products and with the assistance of Premier Research reported it to the appropriate Competent Authority according to applicable MEDDEV regulation. 

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Case Study: Medical Device

Supported a company specializing in implants…

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​A small, specialty pharmaceutical company contracted Premier Research to prepare and submit an NDA for an opioid analgesic which included regulatory strategy and oversight, as well as a full spectrum of biometrics and medical writing activities.

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Case Study: Analgesia

Meeting timelines for new drug application…

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​We conduct research studies in many areas such as: Acute and Chronic Pain, Cardiovascular Disease, Oncology, Skin Conditions, etc., if you would like to be considered please contact us…

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Study Opportunities

We conduct clinical research studies in many areas...

​Being a clinical investigator will provide you with access to the latest advancements in medicine. Learn More

Clinical Research Expertise from Around the Globe
Our extensive network enables us to apply local knowledge and expertise to international projects. Our broad operational footprint allows many options for subject enrollment and enables access to diverse patient populations.  Learn More

From 2008 through 2013 Premier Research conducted 60% of their clinical trials in North America and 40% throughout Europe.

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