Int J Pharm Med 2007; 21 (6): 453-456 1364-9027/07/0006-0453/$44.95/0

DIRECTORY

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Workplace 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 40 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, The Cottage, Culters Court, Copyground Lane, High Wycombe, Buckinghamshire, HP12 3HE, UK. Tel: +44 (0) 1494 464 585, fax: +44 (0) 1494 452 861. E-mail: [email protected]; Website: http://www.alphaplus.co.uk AVALON-almega s.l. Consultant Services • Development of new technologies and evaluation of portfolios of new products and/or product modifications Registration of drugs and medical devices in EU countries • • Monitoring of outsourcing services • ‘Substantial analysis’ of pharmaceutical products in their markets. For further information, please contact: Xavier Gras Balaguer MD, Balmes 199, 1A, 08006 Barcelona, Spain. Tel/fax: +34 932 377928 E-mail: [email protected] Clinical Research Consultancy

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27 years’ experience of clinical research in a variety of therapeutic areas, phases I–IV Honorary Fellow of the Institute of Clinical Research Large scale projects managed through freelance regional network

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Committee member of the Virtual Consulting Group, professional bioscience consultants (Website: www.vcgllp.com). 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] Website: http://www.glennyclinical-research.co.uk Consultants in Pharmaceutical Medicine – Australia ‘A problem well defined is a problem half solved’, Winston Churchill. Global experience, connecting with major Pharma Companies on international and national projects, across the spectrum of drug development, from compound discovery, through to commercialisation in almost all therapeutic areas across the prescription, OTC, complementary and medical devices spectrum. Sydney-based, independent consultancy offering: • strategic med – planning • ethics med • forensic and liability med • safety med – pharmacoviligence • virtual med • bush med synthesis • independent safety monitoring board, advertising review (is a specialty). For further information: Dr Sander Becker MB BCh FFPM, PO Box 2028, Rose Bay North, NSW 2030, Australia. Tel/fax: +61 2 9388 2610 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 en-

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try, 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 (paper-based data entry) guarantee a maximum of precision. For further information 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, Clinical 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 plans. For information contact: Dr Elliot Brown on: Tel: +44 (0)2084498788 E-mail: [email protected] o Website: http://www.ebconsulting.co.uk The Goffin Consultancy The Goffin Consultancy was set up in 1999 to provide highquality 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 and pharmaceutical 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] Website: http://www.thegoffinconsultancy.com © 2007 Adis Data Information BV. All rights reserved.

Greenfield Research Ltd Consultancy, courses and software for: • process simulation and improvement • statistical process control in manufacturing and service inustries • design analysis and interpretation • ndustrial process studies, including mathematical modelling, statistical analysis and simulation • design, simulation and analysis of clinical trials. For further information contact Professor Tony Greenfield, BSc PhD CStat. E-mail: [email protected] Website: www.greenfieldresearch.co.uk INTERLAB Your Central Lab – Worldwide 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] Website: http://www.INTERLAB.de 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 • Nanobiotechnology • Personalised medicine • Gene therapy • RNA interference. Further information from: Prof. K.K. Jain MD, FRACS, FFPM, Blaesiring 7, CH-4057, Basel, Switzerland. Tel/fax: +41 61 692 4461 E-mail: [email protected] Website: http://pharmabiotech.ch medcom Drug Development Services GmbH Experienced pharmaceutical physicians, scientists and fieldbased monitors in major European countries for: Int J Pharm Med 2007; 21 (6)

Directory

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Clinical trials, phase II–IV and PMS across Europe and in the CIS • Site management and supplemental staffing services (Europe and US) • 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 US. Certified and experienced centres for clinical trials to current GCPstandards in Moscow. To discuss your specific project’s needs contact: Christian Hinze, MD, FFPM, medcom dds GmbH, PO Box 13 27, D-77673 Kehl, Germany. Tel: +49 (7851) 8986-0, Fax: +49 (7851) 8986-70 E-mail: [email protected] Website: 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 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 Tel/fax: +44 (0) 1438 820 000 E-mail: [email protected] Website: http://www.medicolegal-investigations.com Mediplex Ltd A pharmaceutical physican with over 17 yeasrs experience and with a particular expertise in the clinical aspects of regulatory affairs and medical writing. Regulatory Affairs: Clinical overviews/summaries • • Clinical expert statements (variations/renewals) • Responding to clinical questions from regulators • Preparing for/representation at regulatory meetings • Assessing regulatory compliance (clinical) • Scientific advice applications • Orphan designation applications © 2007 Adis Data Information BV. All rights reserved.

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SmPC harmonisation Switching legal status. Clinical Research: • Clinical development plans/strategy • Clinical study reports and protocols • Primary and review papers (including systematic) • Congress reports, proceedings, abstracts and posters. Medical Affairs: • Copy approval and sign-off • Publications planning • Competitor analysis • Advisory board set-up and facilitation • Sales force training. • Product monographs and detail aids. Contact: Dr Peter Hession, BA, MB BS, MFPM, MTOPRA, Mediplex Ltd, 48 Priest Avenue, Wokingham, Berks RG40 2LX, UK. Tel: +44 (0) 118-9785323 E-mail: [email protected] Website: http://www.mediplex.co.uk Pierrel & PharmaPart AG 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. In 2005, Pierrel acquired a majority interest in PharmaPart. PharmaPart offers pharmaceutical services in: • manufacturing • dosage form development • clinical trial supplies • commercial manufacturing and packaging • clinical R&D • clinical trials • monitoring • biostatistics • data management • consulting • drug development • medical marketing • licensing • quality assurance • regulatory affairs • post-marketing surveillance • support services • training • seminars and workshops Int J Pharm Med 2007; 21 (6)

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medical writing medical translations. For further information contact: Stephan Henauer, MD, or Brian Rees, Bahnhofstrasse 20, P.O. Box 173, 8800 Thalwil, Switzerland. Tel: +41 44 723 59 59, fax: +41 44 723 59 60 E-mail: [email protected] or [email protected] Website: http://www.pharmapart.com Prism Group

Prism Group provide specialist strategic and delivery services in the Drug Development and Medical Marketing arenas. Prism draws on the experience of physicans who have led and continue to lead global development and post-approval medical programmes in both major pharma and emerging biotech. • PRISM IDEAS is focused on peri-approval and post-marketing clinical activities. In particular, this means phase IIIb and IV trial design, and all aspects of medical communications.

© 2007 Adis Data Information BV. All rights reserved.

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PRISM BIODEVELOPMENT works with both large and small clients to define commercially viable clinical development strategies and to guide their implementation. • PRISM PILOT is developing and marketing an integrated suite of software tools to support the optimal design of clinical programmes and to inform decision making. For further information visit our websites at www.prismdeas.com or www.prismbiodev.com. Alternatively, contact one of our team on +44 1270 621 724 or write to Prism Group, Regent House, Beam Heath Way, Nantwich CW5 6PQ, UK. Contact us If your company details are incorrect or if you have a consultancy business that would be of interest to our readership, please contact the journal at [email protected]. New submissions to this section should not exceed 150 words and will be included at the Editor’s discretion.

Int J Pharm Med 2007; 21 (6)