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Int J Pharm Med 2004; 18 (6): 395-400 1364-9027/04/0006-0395/$31.00/0 © 2004 Adis Data Information BV. All rights reserved.

3ClinicalResearch AG 3ClinicalResearch is a full service CRO providing clinical trial services in phases I–IV. We remain committed to phase I and IIa as the cornerstones of our business, and can provide fast-track solutions from first-in-man through to proof-of-concept. • Headquarters near Berlin, Germany (25 minutes from the Tegel airport) • Focus on phase I and phase IIa – Fast Track Solutions • Consulting in all aspects of drug development • Phase I unit (24 beds + 2 sleep labs) located at our headquarters – ideally suited to first-in-man studies • Two phase I/IIa units (24–36 beds and 16 beds) located in the Charité (The University Hospital of the Humboldt University, Berlin) – ideally suited to proof-of-concept studies in a clinical setting • Cooperation with centres of academic excellence – such as the Humboldt University and the Free University of Berlin • Access to patient populations, including: asthmatics, HIV positive, psoriasis, Helicobactor positive, renal and hepatic impaired, elderly • 3C areas of excellence – dermatology, diabetes, CNS, studies in special populations • Proprietary volunteer database For further information contact [email protected]. Tel: Business Development on +49 3302 2022 200. Tel: Chief Scientific Officer, PD Dr med. Bernd Rosenkranz, FFPM on +49 3302 2022 250. 3Clinical Research AG, Neuendorfstr. 20, D-16761 Hennigsdorf, Germany. Web: http://www.3clinical research.com A4 Accuracy An independent reviewer of your clinical reports and dossiers for quality and compliance with house style. Over 20 years’experience in the pharmaceutical industry. Beth Neill BSc, MSc. Tel/fax: 01494 870037. E-mail: [email protected] Alpha-Plus Medical Communications Ltd Medical communications company providing marketing and scientific support for the pharmaceutical industry. The key staff at Alpha-Plus have over 25 years of medical writing experience in the pharmaceutical industry and agency environments. Our aim is to provide a high quality, reliable and cost-effective service, with the writer forming the single point of contact for the client. • Publications planning • Peer-reviewed publications (original articles and reviews) • Congress presentations and reports

• Symposia and standalone meetings • Opinion leader liaison and advisory board meetings • Market support outputs (print and new media) • Publications planning Contact: Alpha-Plus Medical Communications Ltd, Victoria House, Desborough Street, High Wycombe, Bucks. HP11 2NF, UK. Tel: +44 (0) 1494 601 075, fax: +44 (0) 1494 601 076. E-mail: [email protected], Web: http://www.alphaplus.co.uk Barrett Consultancy Registered UK physician with many years’experience in pharmaceutical companies and CRO, and Master’s degree in Medical Law (LLM). Consultant in Pharmaceutical Medicine, Medicolegal affairs and Medical Ethics. Advice on ethical and legal aspects of clinical trials: • Use of vulnerable groups in research • Assessment of risk and potential fraud General Medical Affairs, including: • Interim management of medical departments • Mentoring and training for new physicians • Training for clinical trial staff and investigators • Medical report writing or review • Clinical trial design, advice and support • Drug safety and medical information • Copy review and sign-off • Training for sales and marketing staff in disease areas and ABPI code of practice Regulatory support and advice: • CTX review and sign-off • Discussions with regulatory authorities For further information please contact Dr Jane Barrett on: E-mail: [email protected], or on Tel: +44 (0) 7813 603735. Boardman Clarke Pharmaceutical medicine consultants: • Medical writing • Meeting reports • Formulary packs ABPI code of conduct review of marketing materials Medical support for marketing Sales and GCP training Boardman Clarke, 6 Stanton Road, London SW20 8RL, UK Tel: +44 (0) 20 8255 9330, fax: +44 (0) 20 8255 9339. E-mail: BoardmanClarke@compuserve Clinical Research Consultancy •

21 years’ experience of clinical research in a variety of therapeutic areas, phases I−IV

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Honorary member of the Institute of Clinical Research (formerly ACRPI) • Large scale projects managed through freelance regional network • Member of the Virtual Consulting Group, professional bioscience consultants (Website: www.v-c-g.co.uk) Services offered: • Clinical study management and monitoring • Medical writing and editing, notably preparation of protocols, study reports, conference reviews, papers for publication, ethics committee submissions and clinical research training material • Feasibility studies and surveys of ongoing clinical research Further information from: Helen Glenny PhD, 9 Oak Piece, Welwyn, Herts AL6 0XE, UK. Tel/fax: +44 (0) 1438 717583. E-mail: [email protected] Web: http://www.glennyclinical-research.co.uk Co-Ephycient Independent Pharmaceutical Consultancy A pharmaceutical physician with 16 years’ pan-European experience in large and small companies, conventional pharmaceutical agents and biotechnology, offers medical advice on all aspects of drug development around Europe, across the range of therapeutic areas, phases I−IV, including: • Identification and management of contractors to conduct European clinical trials • Management consultancy relating to clinical departments • Assessment of development/in-licencing drug candidates • Safety review • Medical writing including expert reports • Training in clinical topics and GCP Dr Josephine Glover MA MBBS MFPM Tel: +44 1483 300250, fax: +44 1483 300720. E-mail: [email protected] Consultants in Pharmaceutical Medicine − Australia ‘A problem well defined is a problem half solved’. Global experience, working for major Pharma Companies on International and Regional projects, across the spectrum of drug development, from compound discovery, through to commercialisation in almost all therapeutic areas. Sydney based, an independent consultancy offering Independent Data Monitoring Board Coordination (a speciality); pharmacovigilance, clinical research and issues management, meet© 2004 Adis Data Information BV. All rights reserved.

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ing facilitation, project outsourcing co-ordination. For further information: Dr Sander Becker MB BCh FFPM, PO Box 318, Rose Bay, NSW 2029, Australia. Tel: 61 2 9343 4067, fax: 61 2 9343 4068. E-mail: [email protected] eCR e-Clinical Research GmbH eCR e-Clinical Research is offering its clients (pharmaceutical industry, scientific institutions, contract research organisations) the eCR e-Clinical Research System for the Design and Execution of Clinical Trials and Observational Reports. The eCR System is based on the principle of complete media freedom of choice between Web-based and paper-based data entry, thus giving a maximum flexibility, both for the study planner and administrator, and for the respective test centre. The use of structured operational procedures and electronic aids leads to substantial time savings both in the planning and the execution phase of a clinical trial. Direct data input and online queries (web), as well as an automated 72-hour query system (paperbased data entry) guarantee a maximum of precision. For further information please contact Dr Thomas Bart, eCR eClinical Research GmbH, Zuerichstrasse 64, CH-8700 Kuesnacht, Switzerland. Tel: +41 (0) 43 266 99 90, fax +41 (0) 43 266 99 92. E-mail: [email protected] Elliot Brown Consulting We provide a dedicated pharmacovigilance resource for the international pharmaceutical and biological industries. Our team of highly experienced consultants and associates can provide expert and cost-effective solutions for: • Pharmacovigilance systems and processes • Safety evaluation and risk management • Regulatory compliance • Training Services include support for: • Safety surveillance, safety overviews • PSURs, Clincal Expert Reports • Signal review, benefit-risk assessment • Compliance audits • MedDRA and other terminologies • Process review and improvement • Clinical development and risk management strategies • Risk management strategies For information contact Dr Elliot Brown on: +44 (0)2084498788 or [email protected] Or visit our website on http://www.ebconsulting.co.uk Int J Pharm Med 2004; 18 (6)

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The Goffin Consultancy

Integral Training

The Goffin Consultancy was set up in 1999 to provide high quality evidence-based medicine reviews and health economic studies to the health care industry. In addition, we pride ourselves on our ability to provide valuable input into the successful commercialisation of medical products. Please contact: Dr Richard Phillips MBBS FFPM MBA, Riding House, Bossingham Road, Stelling Minnis, Canterbury, CT4 6AZ, UK. Tel: +44 (0) 1227 709220, fax: +44 (0) 1227 709721. E-mail: [email protected] Web: http://www.goffin-network. co.uk

A new European company specialising in: • Development of new health technologies, in accordance with European regulations and European market • New technologies for medical practice • Transfer of technologies • Scientific communication Further information from: Xavier Gras Balaguer MD, Via Augusta 92, 2o 2a 08006 Barcelona, Spain. Fax: +34 934 15 38 71. E-mail: [email protected]

Sarah Hatty Associates

INTERLAB Your Central Lab − Worldwide

Sixteen years’ experience in global oncology drug development and registration: • Clinical plans • Phase I–III protocol development • Co-ordination of expert advisory panels • Data analysis, interpretation and expert reports • Assessment of in-licensing candidates Dr Sarah Hatty MRCP MFPM. Tel: +44 1372 471495, fax: +44 1372 462508. E-mail: [email protected]

INTERLAB is based in Germany and as your European specialist performs routine and esoteric testing, including microbiology and histology, on a daily basis. Over 20 000 samples a day guarantee top expertise and competitive pricing. Professional data management, information system via Internet, multilingual study support, reliable shipment logistics – worldwide. INTERLAB has partner laboratories in North and South America, Israel, Australia and South Africa. Fax: +49 89 741 39339. E-mail: [email protected] Web: http://www.INTERLAB.de

Heart Research Ltd

MATRIX Clinical Research Ltd (MCR)

Directors: Dr Kim Fox, Dr Karen Summers, Dr Andy Broadhurst. • Heart Research is the first and only European Clinical Research Organization that specialises solely in cardiovascular medicine • Operating in phases II, III and IV of cardiovascular clinical development, Heart Research offers a balance of academic and commercial development that cannot be found in any other European CRO Further information from: Daniel Nasmyth-Miller, Business, Development Manager, Heart Research Ltd, 88 Harley Street, London W1G 7HR, UK. Tel: +44 (0) 20 7935 3238. E-mail: [email protected]

Due to a recent strategic partnership announcement with Internet-based clinical research pioneer Pharma Link FHI, (Research Triangle Park, NC), MCR is now positioned to provide unequalled optimised clinical development services throughout the world. Due to PharmaLink’s exploitation of the leading Internet technology and the clinical expertise of MCR, the e-trial process has catapulted the global drug development process a generation forward enabling significant gains in time-to-market, research quality and cost containment. Further information from: E-mail: [email protected] Tel: +44 (0) 1438 22 1122, fax: +44 (0) 1438 22 1133. Web: http://www.cro.co.uk

Independent Statistical Consultancy Planning and design of: • Clinical trials (all phases) • Laboratory and production experiments • Data analysis, interpretation and presentation • Report writing • Reviews of papers • Short courses (on site) • Litigation support (expert witness) Dr Tony Greenfield BSc PhD CStat. E-mail: [email protected] © 2004 Adis Data Information BV. All rights reserved.

MDSCRIPTS − Medical Writing Service Since 1988 Manuscripts written by physicians with extensive preclinical and clinical research experience – academic (neuro psychopharmacology) and pharmaceutical industry (broad therapeutic range). • Research manuscripts prepared for pharmaceutical industry and investigators • Manuscripts in English for journals in numerous clinical fields • Editorial services • Bilingual in French Int J Pharm Med 2004; 18 (6)

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The aim always is to provide a critical and unbiased interpretation of data without conflict of interest, in the spirit of JAMA editorial sponsorship, authorship, and accountability (JAMA 2001; 286 No. 10). Robert Pigache MD (Lond.), MBBS, FFPM, Le Pontillou, 24610, Villefranche de Lonchat, France. Tel: 00 33 (0) 5 53 81 83 49, fax: 00 33 (0) 5 53 81 33 78. E-mail: [email protected] Jain PharmaBiotech Publication of commercial reports on biopharmaceutical topics and consultation. Areas of expertise: • Applications of genomics and proteomics • CNS drug development • Neuroprotection • Drug-induced neurological disorders Further information from: Prof. K.K. Jain MD, FRACS, FFPM, Blaesiring 7, CH-4057, Basel, Switzerland. Tel/fax: + 4161 692 4461. E-mail: [email protected], Web: http://pharmabiotech.ch medcom Drug Development Services GmbH Experienced pharmaceutical physicians, scientists and field based monitors in major European countries for: • Clinical trials, phase II–IV and PMS across Europe and in the CIS • Site management and supplemental staffing services (Europe and USA) • Data management support • Medical writing and editorial services • GCP-training and audits (Russian–German auditor available) • Regulatory affairs and licensing support A network of expert consultants in Europe and the USA. Certified and experienced centres for clinical trials to current GCP-standards in Moscow. To discuss your specific project’s needs, please contact: Christian Hinze, MD, FFPM, medcom dds GmbH, PO Box 13 27, D-77673 Kehl, Germany. Tel: +49 (7851) 8986-0, fax:-70. E-mail: [email protected] Web: http://www.medcom-dds.de MedicoLegal Investigations Limited (MLI) MedicoLegal Investigations (MLI) is the only private company in Europe offering its expertise and experience to the pharmaceutical industry in the context of research fraud/misconduct. In addition to investigation services, we offer unique training to those in the front line of clinical trials – training that has become even more © 2004 Adis Data Information BV. All rights reserved.

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important with the implementation of the EC Directive. If your professionals are in need of support to identify fraud/misconduct at an early stage and/or concerned about the possibility of having to interview a potentially dishonest investigator, we can give them the confidence to act appropriately and provide you with an enhanced quality of monitoring and auditing. Do they truly understand the difference between ‘sloppy’ work and misconduct? Are you certain they can cope with a problematic interview? Contact: Peter Jay at MedicoLegal Investigations Ltd on +44 (0) 1438 820000 (telephone and facsimile). E-mail: [email protected] Web: www.medicolegal-investigations.com Mediplex Ltd Pharmaceutical medicine consultancy with a focus on clinical regulatory affairs and medical writing. • Clinical overviews/summaries • Clinical expert statements (variations/renewals) • Hearings and appeals • Scientific advice applications • Orphan designation applications • SPC harmonisation • Switching legal status • Clinical study reports • Primary and review papers (including systematic) • Publications planning • Congress reports, proceedings, abstracts and posters Contact: Dr Peter Hession, MB BS, MFPM, MBIRA, Mediplex Ltd, 48 Priest Avenue, Wokingham, Berks RG40 2LX, UK. Tel: +44 (0) 118-9785323. E-mail: [email protected] Web: http://www.mediplex.co.uk Peter Holland Consultancy Consultant in medical writing and clinical R&D with 21 years’ experience as Medical Director and Director Clinical R&D in a major pharmaceutical company. Medical writing services include: • Summaries of medical congress proceedings • Reports of symposia • Product monographs and review articles • Clinical study reports • Product promotional material and ABPI copy approval. Clinical R& D services offered to pharmaceutical companies and CROs: • Rapid patient recruitment to phase II, III and IV clinical studies • Highly trained investigators to GCP standards • Feasibility and pre-initiation reports Int J Pharm Med 2004; 18 (6)

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High-quality data acquisition Regular communication with investigators and sponsoring companies For further information contact Peter Holland MB BS MRCS LRCP MSc Bpharm FFPM, Ashen Wood House, West Tisted, Alresford, Hampshire, SO24 0HJ, UK. Tel: 01730 828285, fax: 01730 828383. E-mail: [email protected]

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• Clinical trials and studies • Competitor comparisons • Physician experience programmes • Health and pharmacoeconomics To discuss your specific product needs, please contact: Dr James Sawyer, Regent House, Princes Court, Beam Heath Way, Nantwich CW5 6PQ, UK. Tel: +44 (0) 1270 621724. E-mail: [email protected]

PharmaPart PharmaPart is well known for its clinical contract research services to companies developing healthcare products. As an established European CRO, its focal point is the operational planning and management of clinical studies for marketing approval purposes. • Clinical study services • Biostatistics and data management • Regulatory affairs • Medical writing • Translations • Quality assurance • Training Stephan Henauer, M.D., PharmaPart AG, Bahnhofstrasse 20, Postfach 173,8800 Thalwil, Switzerland. Tel:+ 41 (0) 1 723 59 59, fax: +41 (0) 1 723 59 60. E-mail: [email protected] Web: http://www.pharmapart.com PIERCE ONE, Consulting − the Operational Part of ‘Pharmaceutical Medicine Consultants, Inc.’ Available for consultation regarding all aspects of clinical research from protocol design through study conduct in a committed and comfortable GCP environment. Investigator and study coordinator GCP training on request. Investigator study manual programme for the discerning clinical investigator. Tel: +1 513 681 4084, fax: +1 513 681 4094. E-mail: [email protected] Web: http://www.pmci.org

Wood and Mills Ltd − Pharma Consultancy Directors: John Wood, Jane Mills, Linda Wood. Consultants in pharmaceutical development specialising in: • Issues management of drug safety problems for marketed products and drugs in development • Gastrointestinal drug development Further information from: Dr John R.Wood, Managing Director, Wood and Mills Ltd, The Mill House, Framewood Road, Fulmer, Bucks SL2 4QS, UK. Tel: +44 (0) 1753 662228, fax: +44 (0) 1753 662311. E-mail: [email protected] Marix Drug Development Limited Marix Drug Development Ltd is an early phase clinical research and consultancy organisation, undertaking phase I and IIa studies at our purpose-built clinical research unit, situated next to the Royal Glamorgan Hospital campus at Llantrisant, near Cardiff. We have the capability to perform the full range of phase I healthy volunteer studies. Our volunteer panel is stable and reliable, while established links with a local GP and hospital consultant network also enables us to undertake phase IIa studies in a wide range of patients. We have invested in state-of-the-art safety monitoring equipment (Philips Intellivue™), which links all our 24 beds to a central station, and we have well equipped respiratory, CNS and CV physiology laboratories. Marix provides creative solutions that reduce the time, cost and risk of early phase drug development.

Prism Ideas, Ltd Prism Ideas provides innovative strategic market development and clinical programmes for products in the peri-launch phase. Utilising a unique approach, the Structured Claim Algorithm, Prism creates powerful marketing tools to support your product, all the way through its life cycle. In addition to market development programmes (programme concepts, tactical planning and project management), Prism can design and provide the tools to implement the following clinical activities tailored to support your product: © 2004 Adis Data Information BV. All rights reserved.

Marix Clinical Research Services

Phase I capabilities • First time in man (FTIM) studies • Pharmacokinetics • Pharmacodynamics • Thorough QTc studies • Food/drug interaction studies Phase IIa capabilities • PK/PD modelling Int J Pharm Med 2004; 18 (6)

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Proof of concept Particular expertise in respiratory, CVS and CNS studies

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Range of psychometric tests including cognitive function, critical flicker fusion and VAS Sacchadic eye movements

In-House Phase IIa Technology – Respiratory/CNS

Respiratory physiology • Plethysmography • Spirometry • Impulse oscillomtery • Pulse oximetry • Full range of challenges • Control of breathing • Breath activated nebulisation CNS physiology • Quantitative EEG

© 2004 Adis Data Information BV. All rights reserved.

Marix Consultancy Services & Project Management

We provide consultancy services and project management in drug development planning, from the preclinical phase through to proof of concept. Our extensive network of therapeutic area experts provides high level input into our projects. For further information please contact us: Marix Drug Development Limited Rhodfa Marics, Llantrisant CF72 8UX Telephone: + 44 (0)1443 234 400, fascimile:+ 44 (0) 1443 234 401. Email: [email protected], web-site: www.marix.co.uk

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