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Drug development is currently a lengthy and expensive process. Pharmaceutical companies are under pressure to reduce costs and development times while increasing the number of products hitting the market.

Integration of Electronic Media in Clinical Trials & Data Management will explore how advances in electronic media can be properly utilised and integrated in order to reduce the number and duration of clinical trials needed for drug development without compromising patient safety or contravening regulations. Senior industry figures will present cutting edge information on how advances in electronic media can be applied to dramatically reduce costs of drug development and speed up clinical trials.

Please register now to guarantee your place at this important conference and valuable workshop.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dr Richard Wyse

Dr Richard Wyse, Chairman, Economic Healthcare Associates & Department of Cardiac Surgery, Hammersmith Hospital, London

9:10 IMPACT OF NEW TECHNOLOGY ON EUROPEAN CLINICAL TRIALS REGULATIONS

David Jones

David Jones, Principal Scientific Officer, MCA

  • How is electronic media currently included in the GCP guidelines?
  • What is the regulatory approach to new technology in clinical trials?
  • Understanding how the quality of electronic data can be regulated through auditing
  • Identifying the need for validation of electronic data management systems for ensuring data quality and regulatory compliance
  • Working toward the common European regulations
  • Implications of common European regulations for clinical trials and data management
  • 9:40 STRATEGIES FOR OPTIMISING VOLUNTEER/PATIENT RECRUITMENT FOR CLINICAL TRIALS

    Dr Jörg Täubel

    Dr Jörg Täubel, Managing and Medical Director, Charterhouse Clinical Research Unit

  • Common recruitment problems for clinical trials
  • The media available to the recruiter
  • Advantages and disadvantages of the various advertising media
  • Using the internet for recruiting patients
  • Accessing on-line patient communities
  • Ethical and confidentiality considerations of on-line recruitment
  • 10:20 CONDUCTING CLINICAL TRIALS ON THE WEB

    Mark Wren

    Mark Wren, Director of Business Management, Phase Forward

  • Considering web technology solutions for clinical trials
  • Understanding key elements for the success of web-based clinical trials
  • What are the risks? Identifying operational and project risks
  • Categorising and assessing risks in web clinical trials
  • Identifying threats, assessing consequences and modifying the environment
  • Implementing a comprehensive risk management approach
  • 11:00 Morning Coffee

    11:20 APPLYING INTEGRATED SOFTWARE SOLUTIONS TO CLINICAL TRIALS

    Dr Michael Bowden

    Dr Michael Bowden, Managing Director, Health Decisions

  • Tackling the multi-centre, multinational clinical trial task
  • Successfully using the internet to cut costs and time
  • Developing an internet-based communication system
  • Screening for suitable patients - Managing the virtual team of CROs
  • Accessing real-time data using web-enabled technology
  • Completing the largest pivotal Alzheimer’s programme
  • 12:00 ELECTRONIC DATA CAPTURE FOR CLINICAL TRIALS

    Suzy Adey

    Suzy Adey, Senior Operations, Operations, Covance

  • An overview of the latest data capture technologies
  • Problems with manual data entry
  • Benefits of automated data capture
  • Advantages of electronic data capture for data collection, management and analysis
  • Regulatory guidelines and electronic data collection: regulations and implications
  • Regulatory changes to take into account new technologies
  • 12:40 Lunch

    14:00 THE CLINIC AND THE WEBSITE: A ROMANTIC NOVEL

    Nick Lucas

    Nick Lucas, Director of Data Management, Quintiles

  • Chapter 1: Happy sites make happy studies
  • Chapter 2: Back to school
  • Chapter 3: ISPs go slow
  • Chapter 4: Help - I need somebody!
  • Chapter 5: Wood pulp shortage averted?
  • Chapter 6: The end - or is it the beginning?
  • 14:40 DATA WAREHOUSES: THEIR USE IN CLINICAL TRIALS

    Paul Athey

    Paul Athey, Principal Consultant, PriceWaterhouseCoopers

  • Understanding data warehouses - How data warehouses can help improve clinical trials
  • Turning data into understanding and insight
  • Providing the means for data recycling - Why recycle data?
  • Integrating information across different therapeutic areas
  • Short term and long term use for data warehouses
  • Extending the data warehouse - infostructure and portal technologies
  • 15:20 Afternoon Tea

    15:40 USING THE INTERNET FOR ADVERSE DRUG REACTION REPORTING

    Dr Alan Rawling

    Dr Alan Rawling, Managing Director, Assured Information Systems

  • Implementing an internet-based ADR reporting system
  • Advantages and benefits of an internet-based ADR reporting system
  • Working towards consistency of site reporting of adverse drug reactions
  • Ensuring effective and efficient communication of ADRs through an internet-based reporting system for the benefit of all parties
  • Regulatory and confidentiality issues of internet-based ADR reporting
  • System validation, management and security issues
  • 16:20 POTENTIAL BENEFITS OF E-BUSINESS PRACTICE FOR CLINICAL TRIALS

    Dr Wolfgang Karrlein

    Dr Wolfgang Karrlein, Director of Strategic Marketing, Siemens Business Services

  • Myths and imperatives of e-business
  • Effects of e-business on the pharma industry
  • Clinical trial process and potential benefits of e-business
  • Examples and experiences from various industries:
  • How can it be done - What can be learnt?
  • The look ahead: A crystal ball view
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    17:10 Networking drinks reception for delegates and speakers

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    David Morgan

    David Morgan, Director of Statistics and Data Management, Axess

    9:10 OPTIMISING WEB-BASED CLINICAL TRIAL TECHNOLOGY

    Brian Green

    Brian Green, Business Manager, BT Clinical Trials Services, BT

  • Building an integrated and technologically structured approach
  • Utilising ‘best of breed’ clinical trial technologies - the application service provider model
  • Assessing process re-design, what approaches? How to get the right results?
  • Effective corporate communication and control, what can an extranet do for you?
  • Attaining global clinical trial reach with the support and help you need
  • Partnership and communication - how can this community work for you?
  • 9:40 SIMULATION MODELLING OF DRUG TRIALS

    Thomas Paterson

    Thomas Paterson, Chief Scientific Officer, Entelos

  • Understanding the need for computer models to integrate data
  • Using a computer modelling platform to make clinical trial design decisions
  • Understanding therapeutic targets and how they achieve the clinical outcomes using simulation modelling
  • Modelling alternate or combinatorial therapies
  • Advantages of in silico drug trials
  • The future of simulation modelling of drug trials
  • 10:20 TECHNOLOGY IS THE WAY FORWARD, FLEXIBILITY IS THE SOLUTION

    Liz Watts

    Liz Watts, Clinical Research Director, TrialNet

  • The ever increasing use of the ‘Global Trial’
  • What are the practical advantages of EDC and associated technologies
  • Two major limitations and their impact on your studies
  • One simple, flexible solution
  • How to maximise your data collection, NOT your budget
  • 11:00 Morning Coffee

    11:20 IMAGING AND WORKFLOW TECHNOLOGIES

    Jon Wood

    Jon Wood, Senior Director, Data Division Europe, Phoenix International

  • An overview of imaging and workflow technologies and systems
  • The benefits of imaging and automated workflows
  • Implementing solutions - defining processes, roles, responsibilities and interactions
  • Database integration - Clinical Data Management Systems and Clinical Trial Management Systems
  • Establishing a new way of working
  • 12:00 CO-ORDINATION OF CLINICAL DATA TRANSACTIONS IN AN END-POINT BASED MULTI-NATIONAL CLINICAL TRIAL

    Ulf Lindström

    Ulf Lindström, Manager, Project Data Management Group, AstraZeneca

  • Understanding the requirements of the clinical project
  • Using DataFax for the transactions of visit-based patient data from clinical centres
  • The use of a web-based system for central information distribution to the local monitors and committee members
  • Collection of information from the local monitors using a web-based system
  • Co-ordination of transactions for Just In Time (JIT) handling of drug supply
  • Web-based system for work flow control of end-point data involving the end-point committee members - Achieved results and the need for commitment
  • 12:40 Lunch

    13:40 MULTI-CENTRE CLINICAL TRIALS

    Stephen Smith

    Stephen Smith, Managing Director, Origin Pharmaceutical Services

  • Barriers to smooth the conduct and speed of clinical trials
  • Organisational approaches to improving the delivery of trials
  • Understanding how electronic data capture and web-based clinical trial design can increase the speed and quality of clinical trials
  • Optimising the use of contract companies
  • 14:20 MANAGING AND IMPLEMENTING CHANGE

    Pamela de Rivaz

    Pamela de Rivaz, Associate Director, Biometrics and Data Sciences, SmithKline Beecham

  • Why are the change management aspects of RDE implementation so important?
  • Some facts about change
  • Approaches to managing change
  • Some experiences SB’s implementation of RDE
  • 15:00 USING A WEB-ENABLED CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS) TO SUCCESSFULLY MANAGE CLINICAL TRIALS

    Dr Lilian Natorff, Medical Director, Pharm-Olam

    Dr Lilian Natorff, Medical Director, Pharm-Olam, , Dr Rosina Maar, Chief Operating Officer, Clinicor

  • Building a sponsor-driven system
  • Using an internet-based CTMS to accelerate clinical timelines - the benefits of real-time access to study reports
  • Benefits of improved communication between CRO and sponsor
  • Time and cost savings of using a CTMS
  • Ways in which streamlined functionality improves study conduct - Adding value with multiple levels of security
  • Improving clinical trials in Central and Eastern Europe through advances in electronic media
  • 15:40 Afternoon Tea

    16:00 ENABLING RESEARCH COMMUNITIES VIA THE INTERNET TO ENHANCE THE CLINICAL DEVELOPMENT PROCESS

    Mark Williams

    Mark Williams, Director of Integrated Solutions, eResearch Technology

  • Definition of constituent members of a research community
  • Assembling modular research application toolkits within electronic research communities
  • Research portals: more than just EDC
  • Providing knowledge dashboards for sponsor, investigation and patient communities
  • Vision to reality: case study and demonstration
  • 16:30 THE REALITIES OF ELECTRONIC-BASED CLINICAL TRIALS

    Graham Downing

    Graham Downing, Executive Director, Biostatistics and Informatics, PPD Development

  • Understanding the considerations in choosing solutions
  • What are the real savings?
  • Understanding the financial implications of e-clinical trials
  • Developing the changing roles across the team
  • Looking to the future of clinical trials management and the use of IT
  • 17:00 Chairman's Closing Remarks and Close of Conference

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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