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The
Clinical Technology Transfer Group, P.L.L.C. (CTTG),
is a law firm providing legal and regulatory advice on the conduct
of clinical trials. CTTG provides sponsors, CROs, and clinical
sites access to expert advice and training of the negotiation
on clinical trial related contracts and regulatory issues affecting
the conduct of clinical trials. |
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Almac
Clinical Services is ideally placed for clinical supply
management of Academically based clinical trials. It is our unique
blend of Pharmacy practice and clinical trial experience that
enables us to offer this- from Protocol input to kit design and
supply chain management . Our core services include comparator
sourcing; over-encapsulation; clinical supply packaging; distribution(+2-8C/frozen/controlled)
via our global depot network; QP Release and analytical services.
We have recently launched a new Shipping Temperature Electronic
Monitoring System Stems and Label Approval System- LAS. Headquartered
in Craigavon, Northern Ireland - US operations are based in PA
and NC with a new NAHQ completing 2010/2011. |
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Alpha
Independent Review Board is a central IRB that provides
complete IRB review services nationwide. We strive to provide
exceptional customer service and are dedicated to protecting the
rights and welfare of every study subject.
For
more information, please visit www.alphairb.com. |
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Aspire
Independent Review Board provides customized IRB services
to meet the unique needs of our clients in all phases of clinical
research. We are committed to the highest level of human research
protection with an emphasis on flexibility, efficiency and a commitment
to customer service.
Aspire IRB is fully accredited by AAHRPP. |
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Akaza
Research is the provider of OpenClinica,
the world’s most widely used open source software for Electronic
Data Capture (EDC) and clinical data management. In use at hundreds
of leading industry, academic, and government research organizations
worldwide, OpenClinica presents a compelling alternative to closed,
proprietary systems. For more information see www.openclinica.com.
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Bio-Optronics
develops, deploys, and operates software products and custom information
technology solutions to help healthcare professionals manage and
optimize workflow, thus enhancing quality, productivity, and patient
and staff satisfaction.
For 25 years, Bio-Optronics has demonstrated leadership in innovation,
expertise in workflow and integration, and a singular approach
to unparalleled customer service.
The Clinical Conductor™ product family, used in over 600
sites around the world, provides comprehensive workflow solutions
for clinical trials, including investigative site and academic
medical center clinical trial management systems.
Hospital bioPoint™ and Momentum™ workflow solutions,
used in over 50 Veterans’ Administration and other hospitals
around the country, include comprehensive scheduling, day-of-care
patient tracking, patient wristband and visitor ID, and point-of-care
medications administration.
A new suite of bioPoint™ and Momentum™ solutions addresses
workflow challenges faced by specialty physician practices and
imaging centers.
For
more information, please visit www.bio-optronics.com. |
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Founded
in 2003 by Ken Getz, the Center for Information &
Study on Clinical Research Participation (CISCRP) is
a first-of-its-kind nonprofit dedicated to educating and informing
the public, patients, medical/research communities, the media,
and policymakers about clinical research participation and the
role that it plays in public health. |
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Budget,
code, and bill trials correctly, consistently. Improve cash flow
through timely sponsor billing and collections. Negotiate better
contracts. Increase operational efficiency. Reduce compliance
risk. Accelerate and improve all your clinical research management
processes with a single, integrated, browser-based software solution:
Click Commerce eResearch Portal |
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Clinical
Financial Services, LLC (“CFS”)is the only
company focused on the financial management of clinical trials.
Our skilled professionals & proprietary systems for Investigator
Contracts and Grant Payments enable clients to improve site relationships,
focus on core competencies, reduce cycle times & cost, and
obtain unparalleled visibility & compliance reporting capabilities.
This business formula allows CFS to deliver high-quality, efficient
and cost-effective service solutions to address many of the financial
and administrative issues that affect the clinical trial process
today. |
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Compass
IRB is a Central IRB located in Arizona. Compass is dedicated
to outstanding customer service and protecting human subjects
through strict adherence to federal regulations. Compass IRB utilizes
a customized online system THE ANCHOR™
for online submissions and distribution of all
IRB documents. THE ANCHOR™ offers - Online
Submissions + Real Time Study Tracking + 24/7 Access
to All IRB Documents + Approval Letters Online and
more! Stop by our Booth and see a demo yourself! Or visit us online
at www.compassirb.com |
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eStudyBinder
LLC., is a provider of electronic online & off-line
self-auditing clinical trial regulatory management systems, and
custom tailored quality & regulatory compliance program development
services. eStudyBinder allows sponsors, monitors, CRO's, IRB's,
DSMB's, regulatory authorities, compliance officers, PM's, DM's,
Investigators and study coordinators to collaboratively communicate,
and perform all aspects of clinical trial regulatory management,
safety & compliance monitoring, auditing, and reporting on
a single efficient platform.
eStudyBinder
is configured to completely support and exceed industry standards
of clinical trial regulatory management procecesses, procedures,
workflow, and documentation beyond existing EDC, CTMS, eCTD, eTMF
and document mangement systems.
eStudyBinder . Toronto Canada . Washington DC. |
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Hall Render provides health care organizations
with full service legal representation. Focused on health law
for over 40 years, Hall Render is recognized as one of the nation’s
preeminent health law firms. With 130+ attorneys serving more
than 500 health care providers, Hall Render is the second largest
health law firm in the nation. For more information go to: www.hallrender.com |
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Huron is dedicated to helping healthcare providers,
regulated organizations, and research programs, improve their
regulatory compliance, gain efficiencies in their clinical research
enterprises, as well as achieve their financial, operational,
and other compliance objectives. We specialize in clinical research
operational assessments, redesign and implementation, including
clinical research billing and human research protections compliance,
conflicts of interest, and other responsible conduct of research
services. |
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Since 1996 professionals at McAllister
Consulting have been guiding organizations conducting
clinical trials through a myriad of complex regulatory compliance
requirements. With our requisite industry experience and technical
expertise in applying federal regulations promulgated by DHHS,
NIH, FDA, OHRP and IRS, to name a few, we are able to address
regulatory compliance concerns throughout the clinical trials
life-cycle. The “life-cycle” approach to compliance
is yet another key difference which distinguishes McAllister Consulting
from other firms. |
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Meade
& Roach, LLP distinguishes itself as a law firm focused
on delivering practical solutions for healthcare regulatory compliance
needs. Each of our partners has more than a decade of focused,
industry-leading experience in this area. The results we have
achieved for clients speak for themselves. We not only understand
the law, we understand our clients—who range from the country’s
largest academic medical centers and hospital systems to stand-alone
specialty facilities and physician practice groups. |
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Medidata
Solutions (www.mdsol.com)
is committed to providing life science organizations the most
advanced tools for planning and managing clinical trials, putting
innovative technology and insightful data into researchers’
hands to help streamline the clinical trial process while helping
accelerate the process of bringing life-enhancing treatments to
market. |
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Neal,
Gerber & Eisenberg LLP is a Chicago-based law firm
providing legal services to a diverse group of clients in a wide
array of domestic and global business transactions and litigation
matters. Our clients include privately and publicly held companies,
financial institutions, not-for-profit organizations and high
net worth individuals. Our client base reflects virtually every
business industry, including a number of Fortune 100 companies.
The firm is comprised of over 200 attorneys spanning 23 practice
groups (including Life Sciences) who share common values of integrity,
a dedication to high quality legal services and a commitment to
diversity. Website: www.ngelaw.com.
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New
England IRB (NEIRB) is an independent IRB providing ethical
review of research projects involving human subjects, including
phase I – IV single and multi-site studies including registry
studies.
- Full
AAHRPP Accreditation
- In
good standing with FDA
- National
in Scope
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- One-week
Protocol Review
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24-Hour Site Review
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Public
Responsibility in Medicine and Research (PRIM&R)
is an international nonprofit organization dedicated to advancing
the highest ethical standards in the conduct of research. Since
1974, PRIM&R has offered conferences and courses that provide
balanced information on ethical and regulatory issues affecting
research, in conjunction with unparalleled access to certification,
networking, and professional development. |
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Quorum
Review was founded in 1992 and earned AAHRPP accreditation
in 2006. In 2008, Quorum introduced the following new streamlining
processes:
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1 day turn-around for sites’ approvals
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North American Board to review Canadian Studies
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3 times weekly board meetings
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New Phase I group created for speed and flexibility
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Daily Board meetings for amendments
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1 time CV and audit submission
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Electronic Portal with all documents available
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Aggressive Phase IV Registry Pricing
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In-house “Fast-track” translations
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Review of Federally funded studies
For
more information on Quorum’s exciting array of expedited
services please contact:
Customer Relations at CustomerRelations@QuorumReview.com,
www.QuorumReview.com |
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For
25 years SciAn Services has provided contract
research services to support the clinical development programs
of the North American Biotech industry with: Strategic Consulting,
Data Management, including EDC, Biostatistics, Medical Writing
and Global Safety / SAE Management services.
SciAn’s extensive experience over 605 studies in a wide
range of therapeutic areas has resulted in SciAn being a leader
in data quality and trial efficiency, and a respected advisor
in all stages of clinical development. SciAn’s participation
in the International Consortium on Anti-Virals, international
and large multi-site regional clinical studies gives SciAn particular
insight into the operational challenges of these studies. |
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Smith
Moore Leatherwood's highly experienced health care attorneys
provide a wide range of services to clients engaging in medical
discovery. We provide legal services to sponsors of clinical research,
academic medical centers and other institutions where federally
funded and industry sponsored research is conducted, and to physician
groups and contracting organizations involved with the development,
performance, and oversight of clinical studies. Our medical research
practice team includes experienced attorneys who are also a registered
pharmacist, a registered nurse, United States Patent and Trademark
Office admittees, a former in-house counsel for a large medical
university, and a former hospital administrator, as well as members
with a Master in Public Health and a Master in Health Administration. |
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CLINICAL
TRIAL SERVICE INDUSTRY
Sullivan Insurance Group, is a leading nationwide insurance
and risk management provider for the clinical trial service industry.
We provide programs for:
- Contract
Research Organizations (CRO)
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Site Management Organization (SMO)
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Academic Medical Center (AMC)
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Trials Management Organization (TMO)
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Institutional Review Boards (IRB)
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Research Site (RS)
Our
involvement in the clinical trial service industry (CTSI) started
in 1995 with a single clinical research organization in search
of the correct professional liability insurance. Since providing
insurance for CRO’s was relatively unusual, existing insurance
programs left CRO’s with too many gaps in coverage. We successfully
worked with our insurers to develop programs that address the
unique issues and exposures for this dynamic growing industry,
including:
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Worldwide Professional Liability
- Premises
Exposures
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Worldwide Product Liability
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Business Interruption, On Site & Contingent
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Directors & Officers Liability
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International Exposures
Established
in 1957, Sullivan Insurance Group is one of New England’s
largest, privately held risk management and insurance brokerages.
Over the past five decades we have built excellent relationships
with world-class insurers like Chubb, ACE, CNA, Endurance, Darwin,
Travelers, One Beacon, Chartis, and Hartford, among many others.
Our commitment to honesty, integrity and service is exemplified
in our day to day dealings with all clients, ranging from individuals
to multinationals, from the start-up to Fortune 1000 companies.
Our organization blends the best traits of national and local
brokers: broad knowledge of the clinical trials services industry,
strong market relationships, national and international services
capabilities, and outstanding claims/loss control services, combined
with an exceptional commitment to personal service. |
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The
Patient Recruiting Agency’s™ data-driven
IN-HOUSE SOLUTIONS include: creative production,
patient/physician outreach, site selection, project management
plus website & telephone prescreening and now with RADIUS365™,
TPRA’s online platform for tracking and managing all response,
referral and retention activities in real-time, TPRA is The
Leader In Successful PATIENT RECRUITING & RETENTION. |
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TrainingCampus.com®
is the home of The International Electronic Education
Network®. It is both a production area and a market place
where members can get discounted products, services and specialties,
build educational material to be sold, exchanged or distributed
to any arena requiring training, assessments and surveys. We provide
the most efficient means of documenting competency for evidence
based education. |
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