Investigator Site Panel on Clinical Supplies

The investigator Site Panel on Clinical Supplies panel was formed in 2011 and comprised of global investigator site representitives, clinical supply professionals and industry researchers involved in the implementation of clinical trials in the United States, Europe and South America.

The panel operates on a singular mission: Identify, raise awareness and drive actionable change to the clinical supply issues impacting investigator sites worldwide in order to support improvements in the execution of clinical research and the patient experience.

Panel Members

Patricia Larrabee

CEO and Founder, Rochester Clinical Research

Pat is the CEO and founder of Rochester Clinical Research (RCR). The dedicated clinical trials site, founded in 1994, works with most major pharmaceutical firms to conduct phase I, II and III clinical research trials. Pat is an Adult Nurse Practitioner and received her Masters Degree from the University of Rochester, School of Nursing. She is a Certified Clinical Research Coordinator with over 25-years experience in academic and private sector employment. Her chief responsibilities now cover all technical, operational and managerial aspects of clinical site management. Pat is member of The Association of Clinical Research Professionals. She is currently the President of the Alliance for Multi-Specialty Research, a national network of independent sites that share best industry practices. Ms. Larrabee is on the advisory council of Rochester Institute of Technology Masters in Clinical Research program and a member of the University of Rochester School of Nursing National Council. Rochester Clinical Research has been ranked by the local business community among Rochester’s “Top 100” companies for 4 years.

Patricia Larrabee

CEO and Founder
Rochester Clinical Research

Lorna Briddick

Managing Partner, Brizzey LLC

Lorna joined the Pharmaceutical Industry as a consultant to P zer, where she was involved in a corporate wide initiative to globalize, and optimize 2000+ clinical supply chain procedures across 6 countries to 200+ global procedures. Lorna was then retained by Schering Plough to lead the optimization of the clinical supply chain, supporting 3 large workstreams that integrated processes across multiple business units. Following that assignment, she was hired by Schering Plough as the Global Clinical Supply Regional Lead for Latin America, serving as the key interface between the clinical supply team and the clinical operations team in Latin America. In this role, she continued her leadership of process integration and optimization in support of the mergers with Organon and Merck. She is now a Managing Partner at Brizzey, a small rm dedicated to helping companies navigate the complexities of bringing new medicines to the market through the reliable, optimized and cost effective delivery of clinical supplies.

Lorna Briddick

Managing Partner, Brizzey LLC

Samantha Carmichael

Lead Pharmacist Clinical Trials / R&D, NHS Greater Glasgow & Clyde

Samantha Carmichael has over 20 years experience as a pharmacist, having spent time in many different areas of pharmacy, including hospital pharmacy and within the private sector working for a large international pharmaceutical company. She is currently the Lead Pharmacist for Clinical Trials and Research & Development within NHS Greater Glasgow & Clyde where she is also one of the Lead Sponsor Representatives when they act as a non-commercial sponsor of studies . NHS Greater Glasgow & Clyde is the largest healthboard in the UK, providing healthcare services to a population of 1.2 million in the West of Scotland. She manages a team of pharmacists and pharmacy technicians who deliver on studies sponsored by NHS GGC or co-sponsored with the University of Glasgow, as well as hosting around 400 CTIMPs across all phases and therapeutic areas. She has practised as a clinical pharmacist in the areas of oncology, critical care and anaesthetics. As well as her Pharmacy degree from the University of Strathclyde, she received an MSc in Clinical Pharmacology from the University of Glasgow and a PhD in Population Pharmacokinetics, from the University of Edinburgh.

Samantha Carmichael

Lead Pharmacist Clinical Trials / R&D, NHS Greater Glasgow & Clyde

Jim Denmark

Founder and CEO, MyClin Clinical Research

James is the founder and CEO of myClin. Prior to myClin, he spent 20 years in the technology and clinical services industry working in the global central lab, CRO, IVRS and centralized ECG elds as a technologist, operational head and general manager. Born and educated in England, Jim has lived and worked in Central Europe, North America, and India. He has held positions with Shell Oil, Meyer International, Scicor, Covance, Nexigent and Reliance Industries and is currently based in Philadelphia. When he isn’t disrupting the clinical trial process, Jim likes to brew English ales at the Redcoat Brewery and has recently learned to sail.

Jim Denmark

Found and CEO
MyClin Clinical Research

Amy Musolino

New Service Development Program Director,
Fisher Clinical Services

Amy Musolino has over 14 years experience in the Pharmaceutical Industry. Her Pharma career began at Mallinckrodt Baker in 2000 where she served as product manager for high performance bulk and laboratory salt and excipient products used in biopharmaceutical manufacturing and research. Amy then spent years several years at Covance serving as the Phase II/III and IRT brand manager.

In 2010, Amy joined Fisher Clinical Services as Program Director of New Service Development, where she has worked to enhance and expand the Fisher Clinical Services service portfolio in order to deliver services that meet the evolving needs of the pharmaceutical industry. She has helped develop meaningful discussion topics for industry events and has served on the board of the Global Clinical Supplies Group.

Amy Musolino

New Service Development Program Director
Fisher Clinical Services

Mary Jo Lamberti

Senior Research Fellow, Tufts CSDD

Mary Jo Lamberti manages multi-sponsored and grant funded research projects at Tufts CSDD. She has extensive experience conducting research on biopharmaceutical industry practices and trends affecting contract research organizations and investigative sites. She has been a speaker at industry conferences and has published articles in trade and peer-reviewed journals. Prior to joining Tufts CSDD, Dr. Lamberti was director of market research at Thomson CenterWatch. She has also worked on federally funded research studies in science education reform and has taught undergraduate courses in psychology at Boston University. Dr. Lamberti holds a B.A. from Wellesley College and a Ph.D. in psychology from Boston University.

Mary Jo Lamberti

Senior Research Fellow, Tufts CSDD

Ana Sanseau

Principal Investigator en Estudios Multicentricos

Dr Sanseau has published 7 scienti c papers on her specialty in Argentina and abroad. In 1998, she was granted the award for Best Scienti c Video by the Argentine Ophthalmological Society (Sociedad Argentina de Oftalmología) for one of her works. In 2006, she received the Poster Award in Canada – Course on Glaucoma Surgery. She submitted 9 scienti c posters and several papers on different subjects of her own choice, as well as 4 scienti c videos and 5 scienti c photographs both in Argentina and abroad. She was co-author of the book Phacoemulsi cation in Dif cult and Challenging Cases with Dr Lu and H. Fine in 1998, as well as of a number of modules for the Ophthalmology Masters Program of the Argentine Ophthalmology Council (Consejo Argentino de Oftalmología) and Salta’s Catholic University (Universidad Católica de Salta). In 1998, she served as co-writer of the chapter on Cataract and Glaucoma of S.A.O.’s Annual Report. She is actively involved in National Campaigns for Glaucoma Detection and Blindness Prevention. She conducts training courses for pharmaceutical companies’ sale forces and works as Principal Investigator in multicenter studies.

Ana Sanseau

Principal Investigator en
Estudios Multicentricos

Kathy Stoddard

Vice President, Benchmark Research

Kathy has worked more than 17 years in an executive position within the research industry. She began her career with an organization that successfully develop and operate ve separate locations. Kathy joined Benchmark Research one year ago and her current position as Vice President involves responsibility for contracts and budgets, business development and investigator growth for the organization. Kathy was born and currently lives in Wichita, KS. She began her nursing career as a surgical nurse and private orthopedic scrub for over 21 years. She has been married for over 38 years and has one son. Personal interests include travel, both domestic and international as well as scuba diving. Kathy is a member of ACRP and NAON.

Kathy Stoddard

Vice President, Benchmark Research
Nicki M. Norris

Nicki M. Norris

CEO, Symphony Clinical Research®

Nicki Norris is the Chief Executive Officer of Symphony Clinical Research® (www.symphonyclinicalresearch.com), a leading provider of specialized in-home and alternate-site clinical services to patients in clinical trials.  Symphony's services significantly accelerate the pace of clinical trials by leveraging its extensive network of clinical service agencies to increase convenience for patients participating in clinical research studies. By taking some clinical study visits to patients in their homes rather than insisting they travel to the investigator site for every visit, Symphony allows more patients to participate and remain in clinical research studies, without unduly burdening the patients or their families and caregivers.  Symphony helps clinical trial sponsors dramatically improve patient recruitment, compliance and retention as well as increase patient and investigator satisfaction.

Nicki Norris brings more than 30 years of experience as a healthcare executive, having successfully led three diverse healthcare services organizations. Spending 20 years at Baxter Healthcare Corporation helped her build a deep and broad knowledge of healthcare, health services, clinical research and medical devices.  At Symphony, she leads a global management team that leverages backgrounds in clinical research, nursing, laboratory, homecare and project management. Educationally, Nicki earned a BS in Finance and an MBA at the University of Illinois at Urbana-Champaign. She has passed the CPA exam.

Nicki M. Norris

CEO, Symphony Clinical Research®

Inside an Investigator Site

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White Paper

REAL-WORLD INSIGHTS FROM THE TRENCHES:
Results of a 2013 Worldwide Survey about the Impact of Clinical Supplies on Investigator Sites

In the high-stakes world of clinical development, sponsors develop protocols with a focus on testing clinical endpoints and, often, with somewhat less appreciation for the practical implications of the designs on investigator sites and patients. At a time when the number and complexity of trials are escalating.

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PUTTING VOLUNTEERS FIRST:
What Every Clinical Team Should Consider Before Developing the Next Protocol

Some call it a buzz phrase, others a movement. Regardless of what it is, momentum continues to build around “patient centricity,” a concept that is captivating the biopharmaceutical industry and spawning everything from articles and conferences to surveys, webinars and lively LinkedIn exchanges.

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