Key Staff http://www.zachmayo.com/home/staff/905-frontpage-content Tue, 31 Oct 2017 22:28:04 -0500 Joomla! - Open Source Content Management en-gb smayo@emissary.com (Emissary.com) Accelerating Clinical Trials with Experience & Advanced eClinical Technology http://www.zachmayo.com/ http://www.zachmayo.com/ Emissary clinical research partners with pharmaceutical and medical device companies to develop new medical products

Emissary International

Contract Research Organization (CRO)

Emissary International has been navigating the clinical trials process for over a decade, earning itself a second-to-none reputation with clients in the medical device, pharmaceutical, biotechnology and contract research organization (CRO) industries. In the complicated waters of clinical research, successful companies are guided by the foresight and expertise of an experienced partner. Since 1995, Emissary has been leading rigorous, detail-focused clinical research studies across a broad range of therapeutic areas, helping clients bring dozens of new medical products to market quickly and efficiently.

In the complicated waters of clinical research, successful companies are guided by the foresight and expertise of an experienced partner like Emissary International.

By combining Emissary’s therapeutic experience and a suite of technology-enhanced clinical trial services with the project management capabilities of a traditional contract research organization, the company has been able to launch enduring partnerships with a broad array of sponsors — from pharmaceutical and biotechnology companies to medical device manufacturers — and even with other contract research organizations that rely upon Emissary’s experienced monitors and the company’s electronic data capture (EDC) technology to supplement their service offerings.

Time-to-market pressures play a defining role in new medical product development, perhaps now more than ever. In this environment, experience and knowledge become critical in expediting clinical research programs. This is the reason Emissary places high value on the experience of its team. Emissary is proud of its track record in the vigilant planning, managing and monitoring of clinical research studies. This means the soundness of a clinical trial is never in question, and investigational new product development goals are reached without delay. No two clinical trials are alike, which means every Emissary partnership is anchored by the individual needs of the clinical development project at hand.

Emissary supports clients with a broad range of
regulatory-compliant services including:

    • Clinical Protocol Development
    • Case Report Form Design
    • Electronic Data Capture (EDC) System
    • Investigator Identification & Qualification
    • Monitoring and Project Management
    • Clinical Site Management
    • Data Management & Statistical Analysis
    • Medical Writing & Regulatory Submissions
    • Auditing and Quality Assurance

Emissary’s in-depth clinical research experience also led to the development of TeamTrials© Web-based electronic data capture (EDC) platform for streamlining the clinical trials process. In building the TeamTrials platform, Emissary leveraged its expertise in how clinical trials are conducted to ensure that the system delivers efficiency throughout the entire process – from study setup to database lock. TeamTrials is incorporated into day-to-day operations, helping Emissary save time and cut costs for clients’ clinical development projects, and enabling the participants in the clinical trial to work together as a team.

TeamTrials enables easier collaboration among all members of a clinical research team. TeamTrials isn't just an electronic version of a paper-based trial, it is designed to make every step of the clinical trial more efficient, to make every team member's job a little easier. Naturally, TeamTrials supports open standards to enable smooth integration throughout the clinical development process.

Why Emissary?

Because, Emissary has the team, the experience, and the technology to accelerate your clinical trial and guide your project to success, even over the roughest seas!

 

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smayo@emissary.com (Steve Mayo (admin)) Frontpage Content Sun, 31 Mar 2013 18:32:52 -0500
Peter Shabe - Biostatistics http://www.zachmayo.com/home/staff/901-frontpage-content/emissary-staff/52-peter-shabe http://www.zachmayo.com/home/staff/901-frontpage-content/emissary-staff/52-peter-shabe Peter Shabe, MS, has over twenty years of experience with clinical trials. This experience spans such broad therapeutic areas as recombinant biologics used in cancer and infectious disease, analgesics, dematologics, birth control products, over-the-counter pain relievers, and particularly extensive work in the field of medical devices. His career roles have included managing large clinical data management and biostatistics operations for both pharmaceutical companies and contract research organisations.

Pete earned his undergraduate degree in computational science with a minor in psychology, followed by a masters in statistics from Marquette University in Milwaukee, Wisconsin. He joined the clinical research industry in 1985 as a bio-statistician for Syntax Laboratories. In the ensuing years, he has held positions of increasing responsibility with Cetus Corporation, Collagen Corporation, Parexel, and Resource Biometrics. In 1996, Pete founded his own company, Advance Research Associates where he manages a team of biostatisticians and data management professionals for Emissary's clients worldwide.

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Frontpage Content Sat, 22 Mar 2008 23:14:19 -0500
Sarah Lenington - Clinical Operations http://www.zachmayo.com/home/staff/901-frontpage-content/emissary-staff/51-sarah-lenington http://www.zachmayo.com/home/staff/901-frontpage-content/emissary-staff/51-sarah-lenington Sarah Lenington, Ph.D, earned her undergraduate in mathematics and philosophy with Magna cum Laude honors and then completed 3 years of medical school at the University of Minnesota. Deciding to pursue a career in academia instead, Sarah next obtained a doctorate in biology from the University of Chicago and a post-doctoral fellowship in cancer epidemiology at the University of Illinois. She then took a faculty position at Rutgers University, rising quickly to become an Associate Professior in the Institute of Animal Behavior.

In the 1990's, Sarah gained invaluable international experience, initially working in genetics research at The Hebrew University in Jerusalem before entering the medical device industry. Working as an applications specialist for a emerging company in the field of breast cancer detection, Sarah travelled extensively to China, Korea, North America, Latin America and across Europe liaising with world-renowned cancer researchers and breast cancer specialists. In this role, Sarah was integral in negotiating a deal with Siemens to co-market this technology, which then lead to a position directly with Siemens and has published extensively in the fields of cancer, genetics, biology, and animal science.

In 2002, Sarah moved back to the United States to serve as the worldwide director of clinical development for a medical device company. In this role, she designed study protocols, managed a staff of clinical research associates, and undertook the statistical analysis and medical writing task for a major PMA application. Sarah is named in the patent for this breast cancer detection technology and authored all the regulatory submissions.

After taking this company thru the PMA process, including making presentations to the FDA, Sarah joined the team at Emissary, which had been the CRO assisting her innovative company. In her role with Emissary, Sarah continues to manage clinical trials, direct clinical research associates, recruit clinical trial sites, and undertakes various medical writing and clinical data analysis tasks for Emissary clients internationally.

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Frontpage Content Sat, 22 Mar 2008 22:12:51 -0500
Steven Mayo - Emissary's CEO http://www.zachmayo.com/home/staff http://www.zachmayo.com/home/staff Steven W. Mayo, PD, CCRA, PMP is the founder and president of Emissary International, LLC, a contract research organization providing clinical trial management services in North America and Europe. Steve holds a Doctor of Pharmacy degree and subsequently trained as an MBA. He is a Certified Clinical Research Associate (CCRA) from the Association of Clinical Research Professionals and also is certified as a Project Management Professional (PMP) by the Project Management Institute.

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Frontpage Content Wed, 12 Mar 2008 13:54:09 -0500