To receive details of the
meetings packages and sponsorship options still available, please
contact:
Steve Hambrook, Conference Director steve@globalengage.co.uk
+44 (0) 1865 811189
Silver Sponsor
George Clinical is the contract research arm of The George Institute,
an independent, global scientific research institute with headquarters
in Australia and offices in China, India and UK.
George Clinical conducts global, multi-centre clinical trials in its
areas of expertise, including cardiovascular disease & diabetes,
neurology, renal disease, musculoskeletal conditions and critical care
medicine.
With investigator contacts in 40 countries and over 300 sites under
management, George Clinical couples large scale global patient
recruitment with scientific credibility.
George Clinical offers full service clinical trial management,
including protocol development, clinical monitoring, project
management, data management, statistical services and endpoint
management, delivering the essential elements of high quality clinical
research.
With a fully integrated
GxP-compliant transport, storage and distribution system in place and
over 140 wholly-owned ISO 9001-certified offices in 50 countries, WORLD
COURIER is the world’s largest and most experienced specialty courier
company. It is uniquely positioned to meet the most demanding
pharmaceutical industry requirements for managing time- and
temperature-sensitive clinical trial materials used in global studies.
For over 40 years, World Courier has set the industry standard for
delivering customized global transport services to clinical trial
professionals − providing temperature-controlled transport, storage and
distribution services for investigational drugs and clinical trial
materials used in global clinical trials.
World Courier is the only specialist courier company dedicated to
treating every shipment on an individual priority basis, delivering
customized solutions and value-added services to the pharmaceutical and
biomedical industries.
A Fully GxP-Compliant
Pharmaceutical Supply Chain
Following an extensive review of international Good Practice (GxP) and
Quality Management standards and the successful implementation of
company-wide compliance processes in 2009, World Courier meets all
necessary standards for GxP-compliant status as it applies to the
courier/transport industry. Each World Courier office is ISO
9001-certified and has locally-based IATA-certified Dangerous Goods
personnel. World Courier also operates state-of-the-art GMP-compliant
investigational drug storage depots in 11 strategic and developing
markets, ensuring that the pharmaceutical supply chain is fully secured
from origin to destination. World Courier’s fully integrated
GxP-compliant service system encompasses:
Clinical Trial Transport
Clinical trial transport services include:
• development of transport schedules to/from
investigator sites
• site assistance including review of protocols,
documentation, permits, paperwork, packaging, etc.
• cold chain services including
temperature-controlled packaging, supplies and expertise
• in-transit dry ice/gel-pack replenishment and
temperature monitoring
• strict adherence to global SOPs for all
biopharm-related shipments
• individual shipment monitoring from pick-up to
delivery including real-time online tracking with protocol and
site-specific details
• customs clearance and delivery in over 220
territories and nations
• pre-customs clearance whenever possible for
shortest transit times
• around-the-clock availability, including weekends
and holidays
Investigational Drug Storage
Depots
World Courier’s currently operates ISO 9001-certified and GMP-compliant
investigational drug storage units in Argentina, Australia, Brazil,
Chile, China, Colombia, India, México, Perú, Russia and
South Africa, with new facilities in Singapore and Japan currently
under construction. Leading pharmaceutical companies worldwide rely on
these facilities to dramatically improve clinical trial logistics in
challenging and strategic regulatory environments. World Courier’s
state-of-the-art facilities offer:
• Validated 15°C to 25°C, 2°C to 8°C,
-20°C, and -70°C storage areas for
investigational drugs and other
temperature-sensitive materials, secured in closed
lockers for maximum confidentiality
• Storage for ancillary supplies and returned drugs in
non-temperature
controlled areas
• Comprehensive site management SOPs
• Full-time on-site pharmacists
• Remote Internet-based client access
• Same- or next-day distribution to in-country locations
Global Research Services (GRS)
is an international CRO with a focus on cardiovascular, renal and
metabolic research. GRS partners with sponsors to provide fully
integrated clinical trial services, high performance teams, geographic
reach and innovative strategies for accelerated subject enrollment,
rapid study start up and streamlined services for Phase I-IV compound
and device development. Headquartered in Rockville, Maryland, GRS
reaches clients around the globe with offices in North and South
America, Europe and Asia.
GRS’ Clinical Services in China
GRS has been operating its wholly owned subsidiary in China, Global
Medical Consulting Services (Shanghai) Co. Ltd., (GMCS) since 1998 and
a biometrics center established in 2002 using state-of-the-art Oracle
Clinical 24 CFR part 11 compliant data management systems. GRS’
Shanghai biometrics center has provided superior data management with
high volume data entry capacity and quick turnaround in support of
clinical drug development programs. We have an uncompromising
commitment to provide superior clinical trial management services by
providing highly qualified staff that operate under ICH, GCP and FDA
guidelines. GRS’s biometrics division has been audited by a number of
international pharmaceutical clients and the SFDA and commended on the
quality of operations. The company has increased its services to offer
full management to both Western and Asian pharmaceutical, biotech and
medical device companies intending to conduct clinical trials in China.
Services include:
• Protocol and case report form development
• Site selection
• Site monitoring
• Safety monitoring
• Project management
• Data management and biostatistics.
GRS’ Differentiators – an
Experienced Global CRO
GRS differentiates itself from our competitors by providing focused
therapeutic expertise in cardiovascular, renal and metabolic studies
with over 20 years of experience, presence on 5 continents and
innovative strategies for successful study completion, site selection,
study start up and subject enrollment. GRS is an experienced
cardiovascular CRO with a proven track record of meeting or exceeding
enrollment targets as well as being a "Rescue Specialist" with access
to patient populations in established and emerging markets. GRS
utilizes high-end technology for the conduct of our sponsors’ clinical
trials which enables us to track and monitor the quality of our
services in real time. Our experienced operations team members have
established processes, procedures and start up tools that allow GRS to
get sites up and running in rapid succession. We excel in coordinating
start up of global trials with detailed knowledge of international
regulatory submission processes for reduced delays in study approval.
GRS has streamlined study design, project and site management, time
efficient data management, targeted clinical monitoring, global
pharmacovigilance, integrated regulatory support and, innovative
communication tools. GRS pays full attention to making each project
seamless from start to finish.
We generate value for you by delivering quality & timely result.
PHARMACONS is an established Contract Research Organization comprising
a group of experienced and enthusiastic professionals at all levels
from global pharmaceutical, biotechnology and CRO companies. We operate
in Australia, Belgium and China with associates in America, Japan and
other Asia countries. This is one CRO company which truly understands
the needs and processes of pharmaceutical and biotechnology companies.
PHARMACONS provides contract clinical research and development
services, workable solutions and client satisfaction to your R&D
needs. We offer viable strategies, plans, solutions, quality and timely
results which allow you to achieve shorter time to market and speed to
value.
Pharmacons has the systems and processes supported with our long-term
experience and the skills of our people in the region.
PHARMACONS is determined to become a top quality CRO in Asia-Pacific
region. Contacts:
KOMTUR PHARMACEUTICALS is one of the world‘s leading
providers of integrated procurement services for pharmaceuticals.
Benefitting from almost half a century of experience in the field, we
offer our customers a unique blend of services, an independent global
infrastructure of 7 offices and a consistent focus on our core fields
of expertise:
CLINCIAL TRIAL SOURCING. CLINICAL
DISTRIBUTION. SPECIAL DISTRIBUTION. INTERNATIONAL PRE-MARKETING
CAMPAIGNS.
Komtur’s focus lies on comparator drugs and any supportive, rescue or
other additional medications used in the clinical trials of our clients
from Phase I to Phase IV.
Our regional office in Shanghai, co-ordinates all activities of Komtur
in the Asia-Pacific markets, delivering world class service at all
service and project levels in Japanese, Mandarin, Korean, English and
German language – tailor made to your clinical trial project needs.
We cover the whole region with unparalleled networks of licensed
suppliers and depot partners. Depending on the design and requirements
of your or your customer’s clinical trial project, Komtur
Pharmaceuticals offers the full range of preliminary research, full
sourcing and supply chain management as well as clinical distribution.
As an alternative you are free to choose any of our service modules as
a stand-alone solution.
Regardless which service you finally choose, you may rest assured that
when collaborating with Komtur Pharmaceuticals in Asia you will
automatically profit from the experience and worldwide resources of our
whole group.
Quest Diagnostics Clinical Trials provides laboratory solutions by
harnessing the power of the entire Quest Diagnostics organization,
including unsurpassed global central laboratory and biomarker services,
diagnostics & esoteric testing, and research & development
innovation, combined with one of the world’s largest clinical
laboratory, a single global database, and unparalleled scientific and
logistics expertise.
What sets us apart from the competition is our:
Scientific Expertise - With approximately 900 in-house scientists and
pathologists across the organization, Quest Diagnostics has the
unsurpassed scientific expertise and broad therapeutic experience to
provide you with superior leadership and consultative services
Laboratory Excellence -As part of the world's largest clinical
laboratory, we put unsurpassed resources, knowledge and experience in
laboratory management to work for you on each clinical trial study
Global Reach - Quest Diagnostics provides you with the worldwide
laboratories you need to support your global trials. With Quest
Diagnostics central lab facilities in North America, Europe, and
affiliate laboratories in China, Singapore, Australia, and South
America, we support investigative sites in over 4,000 cities across 60
countries"
Tech Observer is a global clinical research organization
providing a comprehensive range of clinical services in Phase I-IV
clinical trials to the pharmaceutical, biotechnology and life sciences
industries. We at Tech Observer have built a multi-disciplinary team
with the optimum combination of education, skills and experience that
ensures QUALITY services for the clients. Our flexible service model is
setup to provide end-to-end study support or customized support as on
needed basis. Our goal is to provide exceptional services for our
clients' clinical trials. These services include clinical research/
operations, data management, biostatistics, Pharmacovigilance, medical
writing and consulting services.
Headquartered in New Jersey, USA; and other office locations in London,
UK, Tokyo, Japan and New Delhi, India; we offer our services across the
globe and help Pharmaceutical, Biotech, and Healthcare companies at any
corner of the world to benefit from our cost-effective quality
solutions right on time every time, thus enabling our clients to
maximize their market share.
Our commitment to our clients is to provide quality data to agreed
timelines with expertise, flexibility and to the total satisfaction of
our clients. We welcome the opportunity to connect with you to discuss
our company’s high standards and unique qualifications in more detail.
RPS, The Next Generation CRO, provides comprehensive global Phase I-IV
clinical development solutions to the pharmaceutical, biotechnology and
medical device industries. By combining an experienced clinical
research operations infrastructure with the industry’s largest
resourcing engines, RPS is uniquely positioned to offer our Clients a
broad spectrum of outsourcing solutions. These solutions range
from globally integrated functional and cross-functional programs to
enhanced global full service solutions, and are powered by highly
experienced and seasoned project teams providing innovative, seamless,
cost-effective and high quality services.
