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Failure to efficiently manage clinical trials data results in:
  • Massive revenue loss
  • Unacceptable delays in trials
  • Compromised patient safety
  • Undermined data validity

We have identified the need to provide a forum which will address how best to avoid these problems, and so increase the potential of your current trials.

The event provides a forum for teams involved both in clinical trials and data management, to discuss the latest technologies, implications of new regulations and the current status of trials.

The event specifically includes the impact of new directives.

Unique opportunity to learn from the leading experts including:
  • Dr Elaine Godfrey, Pharmaceutical Assessor, Medicines & Healthcare Products Regulatory Agency
  • Dr Johann Proeve, Global Head, Data Acquisition & Management, Bayer
  • Dr P K Tandon, Senior Vice President, BioMedical Operations, Genzyme
  • Dr Marco Taglietti, Vice President, Clinical Research, Schering-Plough Research Institute
  • Lauri Sirabella, Executive Director & Site Head, Clinical Study & Data Management, Pfizer
  • Dr Michael Herschel, Director, Clinical Research, GlaxoSmithKline
  • Dr Jerald Schindler, Assistant Vice President, Biostats & Clinical Tech, Wyeth Research
  • Derek Gilfillan, European Operations Manager, Global Clinical Data Management, Eli Lilly
  • Hani Kamel, Quality & Security Advisor, Novo Nordisk
Programme highlights include:

REGULATIONS: Hear about the impact of new Directives including CDISC standards and the EU Directive
RECRUITMENT & STRATEGIES IN DATA MANAGEMENT: Understand the current issues surrounding employment and change management
ELECTRONIC DATA CAPTURE: Make valuable contacts with those at the forefront of development and implementation
MANAGING YOUR CLINICAL TRIAL DATA: Learn from the experiences of leading companies about cost, quality and efficiency
DATA SECURITY ISSUES IN CLINICAL TRIALS: Gain an insight into global data security concerns and measures

Previous attendees include:

Abbott Labs, Acurian, ADAC Labs, Agorahealth, Amersham, Amgen, Antisoma, Astra Zeneca, Aventis, BASF, Baxter, Bayer, Biogen Idec, Biomit, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltech, Celsus, CenterWatch, Chiltern, Clinicor, ClinPhone, Cogtest, Convance, CroMedica, Daiichi, Datatrial, Eisai, Elan, Eli Lilly, eResearch Technologies, F Hoffman-La Roche, Genzyme, GlaxoSmithKline, H Lundbeck, ICON Clinical Research, Intercern, Inveresk, J&J, Kendle, MDS Pharma, Medicines & Healthcare Products Regulatory Agency (MHRA), Merck Sharp & Dohme, NIH, Novartis, Novo Nordisk, Organon, OSI Pharma, Parexel, Pfizer, Pharmacia, Phase Forward, Powder Ject, Quintiles, Roche, Sandoz, Schering, Schwarz, Solvay, Teva, Unilever, Wyeth Research, and many, many more...

Conference programme

8:30 Registration and Coffee

9:00 Chairperson's Opening Remarks

Barry Burnstead

Barry Burnstead, Program Management, Phase Forward

9:10 MANAGING CLINICAL TRIALS

Dr Jerald Schindler

Dr Jerald Schindler, Assistant Vice President, Biostatistics & Clinical Technology, Wyeth Research

  • Why should you manage a clinical trial or drug development programme?
  • How do you manage a clinical trial?
  • What problems could be avoided in the management of clinical trials?
  • Can effective trial management strategies be used in order to maximise the trial’s potential?
  • What is good information management and how does it affect data collection and decision-making?
  • How can reliability and validity be built into data collection?

    Frequent problems and solutions

  • 9:50 21CFR II

    John Farrell

    John Farrell, Director, Quality & Validation, Synapse Partnership

  • A rule to enable the use of computers
  • Key elements and requirements
  • Understanding the relationship between risk, compliance and enforcement
  • Changing impact – the panic/complacency pendulum
  • 10:30 Morning Coffee

    11:00 IMPACT OF CDISC STANDARDS

    Dave Iberson-Hurst

    Dave Iberson-Hurst, Founder / Member, Assero / Clinical Data Interchange Standards Consortium (CDISC)

  • What is CDISC and why do we have it?
  • When should it be implemented?
  • How does it impact industry?
  • Do companies gain by adhering to the guidelines?
  • The benefits of CDISC compliance
  • 11:40 POST-IMPLEMENTATION REGULATIONS

    Dr Elaine Godfrey

    Dr Elaine Godfrey, Pharmaceutical Assessor, Medicines & Healthcare Products Regulatory Agency (MHRA)

  • What has changed
  • How is this happening in practice
  • 12:20 Networking Lunch

    13:50 EMPLOYMENT OF DATA MANAGERS

    Kevin W Smith

    Kevin W Smith, Director, Clinical Study and Data ManagementCNS Therapy Area, Pfizer

  • Current situation - permanent vs contracted
  • What effect is this having on the quality of clinical trial data management?
  • Who to recruit – how do you decide what skills you want from them?
  • Working with minimum resources – how does training and development fit in?
  • How does a data manager build a career?
  • 14:30 INTEGRATING EDC AND IVR/IWR APPLICATIONS

    Bill Byrom

    Bill Byrom, Product Development Director, ClinPhone Ltd

  • Strengths of an integrated solution
  • Technical considerations of system integration
  • Integration touch points, principles and considerations
  • Demonstration movie: real-time integration between IVR and EDC applications
  • Integration touch points, principles and considerations
  • Technical considerations of system integration
  • Integration touch points, principles and considerations
  • Integration touch points, principles and considerations
  • 15:10 Afternoon Tea

    15:40 A RISK-BASED APPROACH TO EDC COMPLIANCE

    Ian McFetridge

    Ian McFetridge, Senior Project Manager, DataCeutics, Inc

  • Provide a framework for focusing on the major events that affect compliance
  • Identify the business process-note where EDC fits into the clinical data management process
  • Note where electronic records are being used in place of paper records
  • Identify and rank compliance risks associated with the electronic records
  • Plan risk mitigation activities and develop metrics
  • Execute risk mitigation activities and update executive dashboard (progress summaries)
  • 16:20 SECURITY ASPECTS OF CLINICAL TRIALS

    Hani Kamel

    Hani Kamel, Quality & Security Advisor, Novo Nordisk

  • What is security?

    Security concerns and measures

  • Stages of clinical trials
  • Security requirements at different stages of clinical trials
  • Security measures at different stages of clinical trials
  • Security of third party and how to control it

    What is being done to ensure data security – security controls, is it enough?

  • Limiting actions for authorised users – is there room to have a role-based design with associated permissions?
  • 17:00 Chairperson’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairperson's Opening Remarks

    Dr Alan Davies

    Dr Alan Davies, European Medical Director,Clinical Development , Kendle

    9:10 IMPLEMENTING A SUCCESSFUL EDC STRATEGY

    Dr Johann Proeve

    Dr Johann Proeve, Global Head, Data Acquisition & Management, Bayer

  • Why growth of eClinical trials has been slow
  • How do you get started?
  • Challenges faced with EDC
  • Impact of EDC
  • Possibilities and limitations
  • 9:50 WEB-BASED DATA CAPTURE

    Derek Gilfillan

    Derek Gilfillan, European Operations Manager, Global Clinical Data Management, Eli Lilly

  • Why use this method?
  • How do you get started?
  • How web-based trials compare to paper trials
  • How is data accuracy and reliability increased
  • Successful and unsuccessful web-based data capture
  • Avoiding and overcoming the pitfalls
  • 10:30 Morning Coffee

    11:00 QUICK START A NEW CLINICAL DATA MANAGEMENT (CDM) DEPARTMENT: HOW EDC CAN HELP

    Lisa Freeman

    Lisa Freeman, Senior Manager, Clinical Data Management, Corus Pharma

  • Step 1: Needs assessment performance for bringing CDM in-house
  • Key decisions needed for the direction of the CDM department
  • Evaluation of EDC vendors
  • Reality check: determination of the processes that your department should undertake
  • Data handling for non-CRF data
  • Key steps to success and lessons learned
  • 11:40 MANAGING THE MAJOR RISKS OF CLINICAL TRIAL DELIVERY

    Dr Janet Jones

    Dr Janet Jones, Global Director, Business Support, Kendle

  • Patient recruitment
  • Data quality
  • Performance metrics at the project, the corporate and the customer level
  • Understanding and using the Balanced Scorecard
  • 12:20 Networking Lunch

    13:50 To be confirmed

    David Baker

    David Baker, Head of Data Management & Medical Writing, Chiltern International

    14:30 PROJECT DATA MANAGEMENT

    Pam Howard

    Pam Howard, Vice President, Biometrics, Europe & ROW, ICON

  • Approaches to project management
  • Planning for pitfalls – risk management
  • What constitutes a successful project?
  • How do you measure success?
  • 15:40 METRICS FOR PROJECT MANAGEMENT

    Dr Margo Taglietti

    Dr Margo Taglietti, Vice President, Clinical Research, Anti-Infectives & CNS, Schering-Plough

  • How have the metrics you use in clinical trials evolved?
  • Implementing a performance metric system that measures cost, quality and efficiency
  • What metrics to include and exclude
  • Applying performance measurement to EDC
  • Impact of EDC and its true cost
  • 16:00 Chairperson’s Closing Remarks followed by Afternoon Tea and Close of Conference

    16:20 ADVERSE EVENT MANAGEMENT IN CLINICAL RESEARCH SYSTEMS

    Barry Burnstead

    Barry Burnstead, Program Management, Phase Forward

  • SAE transfer between Pharmacovigilance and CDM
  • Coding policies in both systems
  • The challenges that EDC and patient diaries introduces
  • Benefits of E2B and CDISC standards to facilitate reconciliation
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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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