Meet our sponsors and exhibitors
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PRA International
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 PRA's Early Development Services (EDS) group provides comprehensive services for Phase I and Phase IIa clinical research, bioanalytical research and data support. Our expertise is primarily with more complex types of studies in which safety and intelligent design are critical factors. PRA EDS conducts more than 100 complex Phase I and IIa studies and over 200 bioanalytical studies yearly for studies recruiting healthy volunteers or special patient populations.
Through harmonized clinical and laboratory facilities in The Netherlands, the United States, and Central and Eastern Europe, PRA EDS offers over 220 beds worldwide. Each Clinical Pharmacology Unit is equipped with the technologies and infrastructure needed for high quality, efficient studies on a wide range of drugs and indications. PRA EDS has developed extensive methodologies enabling us to conduct studies with delicate pharmacokinetic and/or pharmacodynamic objectives.
PRA International is one of the world's leading global clinical research organizations, conducting clinical trials in more than 60 countries across six continents. PRA provides outsourced clinical services across all phases of pharmaceutical and biotech drug development. Through its 30+ years of experience, PRA has developed the operational and therapeutic expertise to provide high quality, global service while maintaining our differentiating PERSONAL ELEMENT of commitment to excellence.
www.prainternational.com
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Kendle
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 Kendle is a leading global clinical research organization providing the full range of early- to late-stage clinical development services for the world's biopharmaceutical industry. Our focus is on innovative solutions that reduce cycle times for our customers and accelerate the delivery of life-enhancing drugs to market for the benefit of patients worldwide. As one of the fastest-growing global providers of Phase I-IV services, we offer experience spanning more than 100 countries, along with industry-leading patient access and retention capabilities and broad therapeutic expertise, to meet our customers' clinical development challenges. Kendle’s clinical development business is focused on five regions – North America, Europe, Asia/Pacific, Latin America and Africa – to meet customer needs.
Kendle's Early Stage expertise includes comprehensive global services, from First-in-Human through Phase IIa/proof-of-concept studies, with world-leading psychopharmacology expertise, in addition to bioequivalence and pharmacokinetic studies for established compounds. We have the agility to address your needs rapidly and can help you develop an optimal Early Stage plan. From initial protocol design through to regulatory submission, we can provide support at agency meetings and help you present and explain complex data.
Kendle's Early Stage units are located in Europe, Canada and the United States.
www.kendle.com
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Medifacts
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 Medifacts International offers best-in-class science, service, and technology on a global basis in support of high-quality cardiac safety and efficacy data collection.
With over 24 years of experience and offices in the US, Europe, and Asia, Medifacts is a global leader in cardiac safety monitoring services. Medifacts’ comprehensive services include:
- ECG
- Holter
- Ambulatory Blood Pressure Monitoring (ABPM)
- Home and Office Blood Pressure Monitoring
- Pulse Wave Analysis
- Diagnostic Telemonitoring
With unrivalled scientific leadership, Medifacts provides a full range of consultancy and analysis services throughout the development lifecycle and beyond. Consultancy services include:
- Worldwide presence with offices on 3 continents
- Expert program and protocol design feedback
- Protocol writing
- Equipment provision
- Site support (24x7x365)
- Comprehensive, hands-on equipment and procedures training offered on-site, at Investigator Meetings, or via teleconference
- Final report writing contribution
- Full ‘gold standard’ ECG analysis
Medifacts’ proprietary WebHeart® platform offers a complete solution to acquiring, displaying, reviewing/measuring, and managing Cardiac Safety data in clinical trials. This system allows for real-time access to transmitted study data. Because no actual programming is needed, the time and cost of both study setup and data submission are dramatically reduced. All data can be converted into an XML format that meets FDA requirements.
Medifacts International’s scientific expertise, proprietary WebHeart® technology, global presence and quality leadership are recognized throughout the industry as the company is increasingly selected as the partner of choice by pharmaceutical and biotech drug developers.
www.medifacts.com
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Chiltern
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Established in 1982, Chiltern is a leading global clinical Contract Research Organization with extensive experience conducting and staffing international Phase I to Phase IV clinical trials across a broad range of therapeutic areas for a wide variety of clients. Chiltern has conducted trials in more than 40 countries and employs 1,400 people in 29 countries. Chiltern provides Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions services. Further information is available at www.chiltern.com.
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Aepodia
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 Aepodia offers Scientific and Operational Expertise in:
*Early Clinical Plan Development
*Execution of clinical phase to Proof of Concept (POC) studies
*Clinical Pharmacology studies to support registration
Spin-out of a top 10 US Pharma Company, Aepodia offers you its experience in different therapeutic areas to develop and execute early phase clinical plan.
www.aepodia.be
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Quotient Clinical
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 Quotient Clinical is a strategic business unit of Quotient Bioresearch. Formed in May 2009 following the merger of Pharmaceutical Profiles Ltd and the Charles River Laboratories’ Edinburgh clinical research facility (formerly Inveresk Clinical Research), Quotient Clinical specialises in early clinical drug development. With over 20 years experience, we offer a uniquely streamlined process to reduce the time from First-in-Human studies through to proof of concept, integrating flexible drug product manufacture into clinical trials. As a specialist in early development services, the company applies new technologies and expertise to expedite the drug development process.
Quotient Clinical can also provide a comprehensive “synthesis to clinic” service to support 14C enabled drug development programs including Human ADME, Phase 0 microdosing, and ivMicrotracerTM studies. With an extensive range of clients in the United States, Europe and Japan, the principal focus of Quotient Clinical is to provide a unique and comprehensive range of high quality early development services to pharmaceutical and biotechnology customers.
Quotient Clinical is at the forefront of innovative drug development using integrated study designs that provide invaluable information on multiple aspects of drug development in a single study, reducing the need for additional trials and substantially reducing time and cost.
www.quotientbioresearch.com
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Parexel
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 PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.
As biopharmaceutical companies conduct more complex and rigorous early phase studies, PAREXEL is a proven partner in providing integrated, development strategies and expertise to guide early identification and selection of the most promising compounds.
Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 51 countries around the world, and has over 9,250 employees. For more information about PAREXEL International visit www.PAREXEL.com.
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Ascent
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 ASCENT is a private organisation specialised in the performance of EXPLORATORY CLINICAL TRIALS IN PATIENTS.
We operate 4 modern hospital-based Phase I units in Eastern Europe; in Moscow and Bucharest, which are entirely dedicated to complex PHASE Ib / IIa/ PROOF OF CONCEPT STUDIES IN PATIENTS AND TO STUDIES IN SPECIAL POPULATIONS (RENAL AND HEPATIC IMPAIRMENT).
We directly access large patient pools across numerous therapeutic areas such as CARDIOVASCULAR, METABOLICS, RESPIRATORY, NEUROLOGY/PSYCHIATRY, IMMUNE DISEASES, INFECTIOUS DISEASES, ONCOLOGY.
EXCEPTIONAL RECRUITMENT SPEED and CAPABILITY make ASCENT unique.
We save our Sponsors a tremendous amount of time, resources and costs in early clinical development.
ASCENT has a solid reputation in the business both for making real what other competitors might consider impossible, and for our service and quality.
www.ascent-crs.com
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LCG Bioscience
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 For more than 14 years, LCG Bioscience has developed experience in a wide range of exploratory phase clinical development studies, often requiring complex clinical procedures, special populations, or surrogate pharmacodynamic endpoints.
We have successfully performed over 350 exploratory phase clinical development studies.
For more information go to www.lcg-bourn.co.uk
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ERT
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 At ERT, our passion and commitment to transforming our clients’ clinical trial and drug approval efforts is clear. Everything we offer — our expert team, unparalleled service, proven process and leading technology — work together, with one single goal: To deliver the most accurate and regulatory-compliant data that will empower your expert decisions, impacting the success of your clinical trial outcomes.
Visit www.ert.com for more information.
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iCardiac
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 iCardiac Technonogies, Inc. is a technologically differentiated cardiac core lab providing expert scientific consultation, end-to-end project management, statistical analysis and the industry’s most sophisticated FDA-accepted cardiac safety assessment methodologies.
iCardiac’s analysis service provides drug developers with more precise and cost-effective methods for QT interval measurement, including our Highly Automated QT(sm), which has been validated by pharmaceutical companies and accepted by the FDA as equivalent to the manual evaluation of ECGs in Thorough QT studies.
In addition, iCardiac provides Beyond QT(sm), a suite of advanced ECG-based cardiac safety markers that have been accepted as secondary end-points by the regulators, and deliver a more accurate assessment of the cardiac safety profile of drugs in development.
iCardiac’s COMPAS technology has been used for over a decade in cardiac clinical trials conducted for and by leading large and medium sized pharmaceutical, biotechnology, and medical device companies. iCardiac’s scientific and medical staff work with the FDA’s IRT team as external experts on improving standards for cardiac safety testing in clinical development.
www.icardiac.com
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Berzelius Clinical Research Center
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 We are helping CRO and Pharma companies getting clinical data earlier and safer!
Berzelius Clinical Research Center (BCRC) is a First-in-Man inspected and approved Phase 0/I/IIa specialist CRO at the University hospital in Linköping Sweden. With access to the medical resources of a University hospital and the ICU expertise of the BCRC staff, BCRC has focused on frontline medical expertise and innovative methodologies to support both CROs and Pharma companies in getting access to human data earlier and safer in the clinical development program.
In addition to our substantial knowledge and experience in early clinical development phase studies, we are also specialized in:
• CLAMP studies, hyperinsulinemic, hypoglycemic
• Renal impairment studies
• Drug/drug interaction studies e.g. warfarin.
• Special patient population studies
• Mass Balance Studies with 14C labelled substances.
• Microdosing pharmacokinetic studies
• Microdose/microdialysis pharmacodynamic-studies, both as a complement to the regular Phase-I programme and as a tool to select substances for further clinical development.
• Medical Imaging in cooperation with Centre for Medical Image Science and Visualization, www.cmiv.liu.se , a world-leading imaging centre, we can perform clinical trials using different types of imaging techniques, e.g. CT, PET, MRI and synthetic MRI.
Welcome to a virtual tour in our clinic at www.bcrc.se!
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Simbec
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 Simbec Research Limited is an independent CRO with over 30 years experience in early drug development. Simbec provides Phase I to Phase IIa Clinical Research Services, and is a full service CRO for Healthy Volunteer and Patient Volunteer studies.
Simbec focuses on providing an efficient, focused, high quality service for the early clinical development of medicinal products. Supported by strong bioanalytical unit and central laboratory, services include:
- Optimised first time in man (FTIM) drug development, including microdosing.
- Imaging Services utilizing γ – Scintigraphy.
- Integrated Data Management and Statistical Analysis
Visit www.simbec.co.uk
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Barrington James
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 Barrington James Limited is a Recruitment Consultancy which was formed to meet the needs of both employers and prospective employees, and specialises in the placement of candidates within the Pharmaceutical sector. While offering the ‘personal touch’, Barrington James Limited prides itself on being able to provide a THOROUGH, PROFESSIONAL and INTELLIGENT service to both the client and the candidate by taking time to gain a complete understanding of the requirements of both parties.
Established in 2002, and with offices in the UK and Asia (Singapore), Barrington James provides a Global Recruitment Solution.
Barrington James is looking to take advantage of the opportunity to meet candidates and clients with whom we have worked for several years at the 4th Annual Exploratory Clinical Development World, Europe, and thank them for making Barrington James a recognised leader in the Pharmaceutical Recruitment field.
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NRSCC
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 The NHS Research Scotland Permissions Coordinating Centre (NRS Permissions CC) consists of a dedicated administrative team based in Aberdeen, which manages the streamlined process of obtaining NHS R&D management permissions for multicentre research studies in Scotland. The Coordinating Centre acts as the main point of contact for applicants undertaking such commercial and non-commercial clinical studies, and is responsible for liaising with NHS Board R&D offices to facilitate Board and management permission prior to study initiation.
The NRS Permissions CC receives and collates the agreed national document set and assigns a unique study identifier - the researcher therefore only has to provide the information on their study once. The NRS Permissions CC registers the study on the national web-based research database and assigns a generic review site, which assesses issues including legal and research governance criteria, before alerting the other participating Health Board R&D offices to initiate the local review. NRS Permissions CC tracks the progress of the study through the permission steps and helps maintain adherence to timelines.
NRS Permissions CC is also forging links with similar initiatives in England, Wales and Northern Ireland to ensure smooth, efficient processes for UK-wide studies. In addition, NRS Permissions CC can facilitate feasibility assessments for commercial companies across Scotland, and we offer a 2-week turnaround timeline for obtaining interest from Scottish investigators in a study protocol for a particular disease area.
Our aim is to enhance the attractiveness of NHS Scotland as a site for large scale research projects. For more information about NRS Permissions CC, visit www.nhsgrampian.org/nrscc or telephone +44 (0)1224 552690.
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Scottish Development International
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InCROM
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 InCROM Europe Plc is part of the InCROM Group of companies. InCROM Group was established in Osaka, Japan over 25 years ago and has grown to become a leading CRO in Japan with international offices in more than 10 cities covering Asia and Europe, employing over 300 staff.
InCROM Europe operates a purpose built, 30 bedded, clinical unit based within the London Independent Hospital situated in Stepney Green, London, UK. The full range of Phase I/IIa studies can be performed from First in Man through to patient Proof of Concept trials. A full service from study design to clinical report can also be provided.
With impeccable Asian credentials and experienced bi-lingual clinical teams, InCROM Group is well placed to perform bridging studies and expedite global drug development programs, all encompassing the high standards of quality to be expected from a Japanese organisation.
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Rules Based Medicine
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 Rules-Based Medicine (RBM) provides comprehensive protein biomarker products and services centered on its Multi-Analyte Profiling (MAP) technology. Its service platform (RodentMAP® and HumanMAP®) provides pre-clinical and clinical researchers with reproducible, quantitative, multiplexed immunoassay data for hundreds of proteins cost-effectively in multiple species, and from a small sample volume. The testing service supports numerous GLP studies and is CLIA certified. Many of these assays are becoming available as optimized kits through our distribution partner EMD Biosciences in the Summer of 2008. The company also offers innovative and proprietary ex vivo testing systems such as TruCulture™, the first fully-closed, reproducible whole blood culture system. It is available with a MAP testing service that provides an unprecedented view of the impact of a drug compound or consumer product on an individual’s immune system without endangering a human test subject. RBM is actively developing multiplex diagnostic tests to detect the presence of complex disease and conditions in areas of unmet medical need such as neuropsychiatry, nephrology, immunology and cardiology. More information about RBM is located at www.rbmmaps.com.
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Lifetree
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 Lifetree Clinical Research and Lifetree Center for Neuroscience Research are a Specialized Research Organization in Salt Lake City, Utah offering our biopharmaceutical clients a broad portfolio of site, CTM and bioanalytical services.
Lifetree is a therapeutic leader in analgesia and CNS with unique expertise in phase I and abuse liability offering a 60 bed unit for phase I-III trials.
Site services include semi-private, private and dorm style subject area’s to meet the need of a variety of study designs. A dedicated recreational room is complete with a secure wireless subject network, big screen TV and gaming areas.
Lifetree’s on-site research pharmacist is capable of storing and handling scheduled I-IV drugs. Our on-site treatment room offers clients and subjects a one stop shop for acute pain trials such as post-operative dental and bunionectomy. The treatment room is also utilized for cerebral spinal fluid sampling performed by on-site, board certified anesthesiology investigators.
Lifetree was FDA audited in 2004 and most recently in January, 2010 with no 483’s.
Lifetree’s attention to subject safety, pristine data and adherence to strict timelines are among the many reasons why clients return.
3838 South 700 East, Suite 202 Salt Lake City, Utah, USA, 801 269 8200
www.lifetreeresearch.com
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Eurofins
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 EUROFINS OPTIMED is a Clinical Research Organisation created in 1990, and located in France, offering all the support required to set up and manage clinical trials, from patient inclusion to study monitoring, from study document definition to the statistical analysis and the final clinical report.
Thanks to 20 years of experience in Clinical Research and dedicated Clinical Pharmacology Units comprising 100-beds, including 32 hospital-based beds, Eurofins Optimed manages studies in ambulatory and hospitalized patients, in various therapeutic fields : Cardiovascular, Neurology, Respiratory, Oncology, … The different teams of experienced clinical research professionals and the up-to-date equipment ensure the launching and management of the whole project according to each trial’s individual requirements.
As a global provider, Eurofins offers all activities linked to clinical trials : bioanalysis, central laboratory, pharmaceutical and regulatory services.
With 20 years of experience, more than 700 clinical studies carried out in healthy volunteers and in patients, and 9001 : 2000 certification for all its activities, Eurofins Optimed is a reliable partner in early drug development.
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ICON
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 ICON Development Solutions specializes in the strategy and delivery of early-phase clinical development services to enable informed, timely decision making for our clients. With global, industry-leading capabilities in early-phase clinical research, bioanalytical, PK/PD, modeling & simulation and the full range of supporting scientific services, we have the operational flexibility to provide stand-alone development services or an integrated full-service solution.
Our clinical pharmacology team has extensive experience in the design, conduct and interpretation of studies in all major therapeutic areas, with a strong reputation for incorporating high science approaches and operational excellence across all elements of your clinical pharmacology program.
ICON has clinical pharmacology units in Manchester – UK (hospital based), Omaha, Nebraska – USA and San Antonio, TX – USA. We offer a full suite of clinical pharmacology studies including all elements of a regulatory package program, as well as translational early efficacy indication solutions. ICON has proven experience in:
• First-In-Human, Dose Escalation, PK, PD
• Multiple Dose Studies
• Drug Interaction Studies
• Bioavailability, Bioequivalence
• Pharmacodynamic Studies
• Biomarkers, Imaging
• Thorough QTC Studies
• Phase I-IIa Patient Studies
• Special Population Studies
• Diabetic Clamp Studies
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Quality Assistance
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 As a leading European Contract Research Organisation, Quality Assistance provides (bio)pharmaceutical companies with scientific, technical and analytical support for generating all the analytical data required during pre-clinical and clinical studies.
Quality Assistance is GMP approved, GLP certified and GCLP compliant. Inspected by the FDA (last inspection 15 and 16 February 2010 with no 483s issued) and the PMDA, the company has an international client base, in both biotech and major pharmaceutical companies.
With more than 27 years’ experience, we employ 110 highly-qualified professionals in premises of 5 200 m², including Mass Spectrometry and ELISA laboratories. We provide clinical professionals with kinetic measurement studies for drugs and metabolites and the follow-up of biomarkers.
Besides our involvement in Clinical Trials, Quality Assistance can provide you with a full service package which includes analytical development, stability testing, release testing, bioanalysis, biopharmaceutical testing, pre-clinical and clinical studies and regulatory affairs guidance.
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Richmond Pharmacology
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 Richmond Pharmacology, Europe's leading Early Phase Full-Service Clinical Research Organisation (CRO), uniquely based within 2 acute NHS London teaching hospitals and the 1st CRO to receive both Standard and Supplementary MHRA Phase I Accreditation for 2 Trial Centres, a clear sign of the quality of our clinical trial facilities and the experience and training of our dedicated and committed staff.
Richmond Pharmacology’s experience has been gained through the conduct of over 500 Early Phase Studies which ensures all studies are managed by experts, providing unparalleled clinical excellence. Our continued commitment to quality, flexibility and transparency can be seen throughout all study activities, an achievement clearly recognised by our committed customer base. Our unique hospital locations guarantee sponsors direct access to acute emergency services, therapeutic expertise and a wide variety of volunteer panels including special panels such as young healthy, elderly healthy, Japanese and patients from primary and secondary care. An acute MHRA accredited Phase I environment, in and out-patient facilities, leading technology and on-site therapeutic consultancy combine to offer a full service on any Early Phase study.
All encompassing, efficient, and expertly run; Europe’s leading specialists in First-In-Human studies; Thorough QT Studies; Japanese Bridging Studies, Subject Recruitment and Patient studies.
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Biopta
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 Biopta are a human tissue pharmacology company offering GLP compliant assays across a range of therapeutic areas utilising most human tissue types.
Biopta’s services improve the predictability and efficiency of drug development by providing, safety and efficacy assays in ethically donated human tissues. These highly predictive assays bridge the gap between cell based screening and in vivo animal models. By providing powerful human data much earlier in the development process, Biopta aims to reduce the risk of late stage failures and add value to early stage compounds.
With unrivalled expertise in classical pharmacological techniques, Biopta can offer assays in a variety of tissues, both diseased and healthy, including; coronary arteries, peripheral subcutaneous resistance vessels, cardiac muscle, cerebral blood vessels, respiratory tissue, pulmonary blood vessels, GI tissue, vascular tissue, skeletal muscle and skin.
Depending on where you are in the drug development process Biopta can advise on the most relevant assay and selection of tissue to provide data on:
1. compound profiling for agonist or antagonist activity
2. potency and efficacy
3. onset and duration of action
4. unwanted adverse effects
5. release of biomarkers such as cytokines or superoxide
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