Contents 2003
Case study: South of the border, down Mexico way (Patient recruitment) Kevin Sherwood-Williams and Anthony Poynton, Pharm-Olam, UK – pp13–14 Well-connected for e-trials (Latin America) Mark Wren, Phase Forward, UK – p16 Widening the web (E-clinical trials) Richard Friedman, Phase Forward, US – pp17–18 Making the ‘medical moment’ matter (E-clinical, patient diaries) Dr Jean Paty, Invivodata, US – pp20–23 Setting a standard for patient recruitment (Good practice) John Yee, BBK Healthcare, US – pp24–26 Inside Edge: Technological solutions for establishing subject compliance in clinical trials Christian Husegaard, Bang & Olufsen Medicom, Denmark – pp29–30 APRIL Guest editorial: Implementing GCP principles is still causing problems (Inspections) Fergus Sweeney, EMEA, UK, – pp3–4 Comment: Dealing with a possible disclosure dilemma (Ethics) Dr Douglas Mackintosh, GCPA, US – p9 What does the future hold for CROs? (Outsourcing) Dr Suzanne Mattingly, Fast Track Systems, US pp11–14 Body of evidence (Data security, biometrics) Robert Jacobs, IBM, US, and Oliver Tattan, Daon, Ireland – pp16–18 A patient strategy (Subject retention) Dr Lesley Milne and Karen McIntyre, Minerva Medical, UK – pp20–22 Realising the rich rewards of shared data standards Nicola Zydek and Dr Christoph Schnorr, Accenture, Germany – pp25–27 Why understanding cultural differences makes business sense (Communication) Dr Laura Brown, Cardiff University, UK – pp28–30 Inside Edge: Document storage – when space is at a premium (Archiving) Christine Twine, Origin Pharmaceutical Services, UK – p31 MAY Guest editorial: The Internet revolution: lessons from periapproval studies (E-clinical) Dr Hervé Laurent, Parexel, France – pp3–4 Comment: Business as usual? (21CFR Part 11) Dr Teri Stokes, GXP International, US – p11 Clinical trials in Australia: Finding out the FACTS Dr Karen Woolley and Dr Mark Woolley, Proscribe Medical Communications, Australia – pp13–16 Living in harmony (Trans-Tasman harmonisation) Anita Kamat, GlaxoSmithKline, New Zealand pp17–18 Inside Edge: LMS – learning made simple (E-learning) Tony Kypreos and Damien Bourke, Bluewave, UK – p21 Why pharma is putting its PET subjects on trial (Imaging) Dr John Thornback, Imaging Research Solutions Ltd, UK – pp23–26 Protecting healthy volunteers in Phase I (Ethics) Dr Frank Wells, Marix Drug Development, UK pp28–29 Datafile: Why do trial costs vary so much from centre to centre (Metrics) Dr Michael Kahn, Fast Track Systems, US – pp30–31 JUNE Guest editorial: The art of the practical? It’s in purpose and processes (EDC, E-clinical) Philip Holt, Integic, US – pp3–4 Comment: EU directive threatens UK research Professor Stephen Evans, Dr Sarah Meredith and Dr Peter Dukes, Medical Research Council, UK – p7 An integrated focus (Biotech) Dr Günter Stetter and Dr Gunthild Johanna Mayr, Rentschler Biotechnologie, Germany – pp8–9 Navigating the regulatory maze (Biotech, regulations) Dr Andy Morffew, Dr Alberto Grignolo, Dr Bruce Babbitt, Dr Hoss Dowlat and Cecil Nick, Parexel, US and UK – pp11–14 EDC: Supporting the engines of innovation (Biotech) Ron Kershner and David Chalmers, Inveresk, US and UK – pp16–17 Recording patients’ experiences: From still life to real life (E-diaries, data collection) Dr Jean Paty and Doug Engfer, Invivodata, US pp19–22 Unearthing the bodies (Auditing, statistical records) Karen Ooms, Statwood, UK – pp24–25 Inside Edge: Designing an effective website to promote patient recruitment John Hollway and Darrin Kiessling, Acurian, US – pp27–29 Datafile: The true economies of scale (Megatrials) Dr Suzanne Mattingly, Fast Track Systems, US – p31 JULY Guest editorial: EU directive raises significant issues for cancer research Dr Richard Sullivan, Kate Law and Dr Julie Sylvester, Cancer Research UK – pp3–4 Research into rare diseases (Orphan drugs) Christina Hägglund, Origin Pharmaceutical Services pp10–13 Coming of age in CEE (Central and Eastern Europe) Dr Boris Golubtsov and Dr Faiz Kermani, Chiltern International, UK – pp15–18 Achieving a meeting of minds online (E-learning) Smiya Jaleel, Phase Forward, UK – pp21–23 Head-to-head: CROs: Does a good little’un really beat a bad big’un? (Outsourcing) Dr Stephen DeCherney, PRA International, US, and Dr Douglas Mackintosh, GCPA, US – pp25–27 Inside Edge: Why shipping is no longer a weak link in the warm supply chain (Clinical trials supply) Tim Jennings, Laminar Medica, UK – pp28–29 Datafile: Does East cost least? (Central and Eastern Europe, outsourcing) Dr Suzanne Mattingly, Fast Track Systems, US – p31
JANUARY Guest editorial: A holistic route to personnel recruitment and retention (Staff development) Vanessa Mallett, Carala Consulting, UK – pp3–4 Strategies to deal with the investigator shortfall (Recruitment) Mary Jo Lamberti, Kenneth Getz and Stephen Zisson, CenterWatch, US – pp9–11 Keeping the study coordinator satisfied (Staff retention) Barry Miskin, Palm Beach Research Center, US – pp13–15 Sharing best practice (IVRS, technology) Bill Byrom and Dr Nikki Dowlman, ClinPhone, UK – pp17–19 Patient safety in clinical trials: Whose legal duty of care? (Litigation) John Kuckelman, Shook, Hardy & Bacon, US – pp21–23 Head-to-head: Does litigation raise standards of care in clinical research? (Ethics) Dr Douglas Mackintosh, GCPA, and Dr Stephen DeCherney, PRA International, US – pp25–27 Inside Edge: Developments in labelling technology allow for greater customisation in global trials James Bailey, InfoPro Solutions, US – pp28–29 FEBRUARY Guest editorial: How will GCP regulations evolve in the electronics age (21CFR Part 11) Dr Teri Stokes, GXP International, US – pp3–4 Opening a gateway to e-reporting SAEs in Europe (Pharmacovigilance, Eudravigilance) Liz Nowell, Alan Rawling and Dr Michael Bowden, Health Decisions, UK – pp9–13 Time to focus on the fast track? (Cancer research) Dr John Whittaker, ICON Clinical Research, UK pp15–17 Captured in time (E-archiving, clinical data) Michael Cooper and Nick Raponi, Synapse Partnership, UK – pp19–21 The role of biomarkers in drug research Matthew Palazzolo, RJM Consulting, US – pp23–26 Inside Edge: Using language translation software in a clinical trials environment David Lawson, Trados, US – pp29–31 MARCH Guest editorial: Keeping subjects motivated: It’s all in the relationship Martyn Jervis, Minerva Medical, UK – pp3–4 Why sponsors are setting their sites on Latin America (Patient recruitment) Dr Ernesto Antunez, CT CRO Clinical Trials, Argentina – pp10–12
AUGUST Guest editorial: Europe grows impatient over delays in paediatric initiatives (Regulations) Dr Daniel Vasmant, Aventis Pharma, France – pp3–4 Comment: It’s time to take account of extra biotech research costs (EU clinical trial directive) Aisling Burnard, BioIndustry Association, UK – pp8–9 Why children with cancer benefit from Phase I studies (Paediatrics) Dr Bruce Morland, Birmingham Children’s Hospital, UK – pp11–14 Prioritise and plan for children’s needs (Paediatrics) Jane Lamprill, Origin Pharmaceutical Services, UK – pp17–19 A never-ending cycle (SOPs) Dr Piera Lukes, IT’sQA, UK – p21 Where GLP meets GCP (Laboratories) Nigel Dent, Country Consultancy, UK – pp23–26 Inside Edge: How videos can help to inform patients’ consent in clinical trials Dr Marvin Greenberg, Boardwalk Medical Video, US – pp28–29 Datafile: What price safety testing? (Cancer) Dr Michael Kahn, Fast Track Systems, US – p31 SEPTEMBER Guest editorial: East meets West: But will Japan’s IT skills give it an edge? (E-clinical) Steve Powell and Hideo Deguchi, Phase Forward, US and Japan – pp3–4 Comment: Countdown to ‘directive’ day (EU clinical trial directive, accession, CEE) Borislav Borissov, Bulgarian Drug Agency, Bulgaria – pp8–9 Managing the move to e-submissions (Common Technical Document, e-clinical) Jim Cook, CDC Solutions, UK – pp10–12 Learning online (E-learning) Marge Krohn and Lowell Zimmerman, WebWise Learning, US – pp14–15 Bearing the weight of expectation (Pregnancy, women) Paul Chester, Novo Nordisk, UK – pp17–19 Scanning data for clinical information (Medical imaging) Dr Colin Miller and Dr Klaus Noever, Bio-Imaging Technologies, US – pp21–24 Inside Edge: From software to healthware (Patient monitoring) Peter Kruger, Wireless Healthcare, UK – pp27–28 Datafile: Optimising protocol design (Benchmarking) Dr Michael Kahn, Fast Track Systems, US pp30–31
OCTOBER Guest editorial: Are the good times now in sight for contract research? (Outsourcing) Dr Faiz Kermani, Chiltern International, UK – p3 Comment: Keep to the spirit of the law (Developing countries, ethics) Peter Motteram, Opttimus Consulting, UK – p9 One man’s medicine: A trial of ingenuity (Pharmacogenomics) Joachim Vollmar and Michael Kirchengast, PRA International, US and Germany – pp11–13 One man’s medicine: The appliance of bioscience (Pharmacogenomics) Professors Hannu Raunio, University of Kuopio, and Jukka Salonen, Jurilab, Finland – pp14–16 Pharmacovigilance: Is this the missing link? (Outsourcing) Liz Nowell, Health Decisions, UK – pp19–21 Connecting the disconnected (Investigators) Dan McDonald, CenterWatch, US – pp22–23 Inside Edge: Outsourcing options for conducting paediatric studies Dr Vivienne van de Walle, PreCare, The Netherlands – pp26–27 A passage to India (Developing countries, ethics) Krishan Maggon Pharma R&D Consultant, Switzerland – pp29–32 Datafile: Budgets versus benchmarks Dr Michael Kahn, Fast Track Systems, US – pp34–35 NOVEMBER Guest editorial: Clinical trial supply: Remember, the patient is waiting Jennifer Worsfold, Fisher Clinical Services, UK – p3 Comment: A safety net with holes (Ethics, IRBs) Dr Douglas Mackintosh, GCPA, US – p7 Labelling: Where global studies come unstuck (Clinical trial supplies, technologies, regulations) Bob Tilling, MAP80 Systems, UK – pp9–11 Managing the expiry date conundrum (Clinical trial supplies, stability testing) Richard Scaife, Quintiles, UK – pp12–14 Placing a drug in the pipeline (Drug delivering, drug-eluting stents) Nicole Yost, Target World Drug Delivery News, UK – pp16–18 Out of Africa (GCP clinical trials) Sarah Baily and Martin Cripps, Origin Pharmaceutical Services, UK – pp20–23
EDC: Evolution not revolution (E-clinical) Philip Holt, Integic, US – pp24–25 Inside Edge: Packing success into the plan (Clinical trial supplies, packaging, blister technology) Joseph Saccomanno, BlisTech Corporation, US – pp26–28 Datafile: Getting to the heart of the cardiovascular indication Mark Hovde, Fast Track Systems, US – pp30–31 DECEMBER Guest editorial: Pharmacoeconomics: When should it enter the equation? Anita Burrell, Aventis Pharma, US – p3 All credit to clinical research (Accredition programmes, continuing professional development) Marjorie Speers, Association for the Accreditation of Human Research Protection Programs, US – pp9–11 Investigator training – Why it’s a matter of course (Continuing professional development) Cristiane Salles, et al, International Centre of Therapeutic Research Latin America, Brazil – pp13–15 Accelerating trials by statistical design (Statistics, interim analyses) Professor Andreas Ziegler, et al, University of Luebeck, Germany – pp16–19 The age of consent? (Informed consent, a history) Patricia Bujembaum, Aventis Pharma, Argentina – pp21–24 Datafile: Evaluating the quality of life (QoL tools, instruments) Michael Kahn, Fast Track Systems, US – p31
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