Pharm Med 2009; 23 (1): 61-64 1178-2595/09/0001-0061/$49.95/0

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Acumentia Ltd Acumentia Ltd is an international network of 40 expert consultants in bioscience, covering healthcare, environment, food, agriculture and business services. We provide a professional, high-quality, personal service giving technical and commercial advice, an independent view on global markets, marketing support and clear signposting of routes to market. Members of the team have indepth skills and experience across a wide range of sectors including: sourcing and supply, clinical trials, regulatory affairs and all aspects of development. We are a one-stop shop with a rapid response to enquiries and can offer bespoke projects tailored to meet your needs. Innovative teams are assembled to provide the necessary skills and you have direct contact with those performing the work. For more information please contact our Business Development Officer [email protected] or see our website www.acumentia.com.

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  30 years’ experience of clinical research in a variety of therapeutic areas, phases I–III  Honorary Fellow of the Institute of Clinical Research (Hon FICR), Chartered Scientist (CSci) and Regional Fellow of the Royal Society of Medicine  Member of the Virtual Consulting Group LLP, professional bioscience consultants (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.glennyclinicalresearch.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

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spectrum of drug development, from compound discovery, through to commercialization 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]

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] 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 ª 2009 Adis Data Information BV. All rights reserved.

ourselves on our ability to provide valuable input into the successful commercialization 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

Greenfield Research Ltd Consultancy, courses and software for:  process simulation and improvement  statistical process control in manufacturing and service inustries  design analysis and interpretation  industrial 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 Pharm Med 2009; 23 (1)

Directory

 Nanobiotechnology  Personalized 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:  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 GCP-standards 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.com

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 ª 2009 Adis Data Information BV. All rights reserved.

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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 years 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  SmPC harmonization  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, MBBS, 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 Pharm Med 2009; 23 (1)

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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  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

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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 postmarketing clinical activities. In particular, this means phase IIIb and IV trial design, and all aspects of medical communications.  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.prismideas. 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.

Pharm Med 2009; 23 (1)