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Failure to efficiently manage data in clinical trials results in loss of revenue and increased delays. In addition to this, poorly managed clinical trials may compromise patient safety and the overall validity of data. SMi has identified the need to provide a forum which will address how best to avoid these problems and subsequently increasing the potential of the trial.

The multinational nature of the pharmaceutical industry and the rapid changes within global technology mean that drug development has become an expensive and lengthy process. Pharmaceutical companies are constantly looking for ways to reduce costs and hasten the process. Recent technological advances within clinical trials research and the data management process, need to be assessed for their ease of implementation and utility, and to determine their efficacy in the clinical trials process.

Clinical Trials & Data Management will address the current data management techniques employed in clinical trials, including the impact of new technological advances in information technology on the clinical trial process. The use of computer models and the real impact of electronic data management on the ease and quality of clinical trial data will also be discussed. Practicalities of managing multinational clinical trials will also be discussed, with an emphasis on regulatory issues and the intellectual property rights involved in global management of clinical trials.

A unique opportunity to learn from leading industry experts including:
· Dr Charles Jaffe, Director, Medical Informatics, AstraZeneca
· Dr François Peterlongo, Head, Data Standards & Services, Aventis
· Hani Kamel, Quality & Security Advisor, Novo Nordisk
· Selina Sibbald, Development Director, Quintiles
· Julie Cartmell, Project Data Management Leader, AstraZeneca
· Barry Burnstead, Head, Program Management, Phase Forward
· Doug Engfer, Founder, President & Chief Executive Officer, invivodata

Benefits of Attending:
· ACCURACY: Gain an insight into strategies to ensure the integrity of your data
· CDISC STANDARDS: Understand how to implement CDISC standards and discover the benefits
· THE FUTURE OF ELECTRONIC SOLUTIONS: Which technologies will survive?
· PATIENT DIARIES: Evaluate how they can be used to enhance data reliability
· PROJECT DATA MANAGEMENT: Learn about the different approaches
· USING THE INTERNET IN CLINICAL TRIALS: Understand the potential for effective data capture and beyond
· TRANSFORMING EDC: Discover how to deploy data capture technologies into live trials

“Very well organised and smoothly run”
Delegate, SMi’s Clinical Trials & Data Management, 2002

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Charles Jaffe

Dr Charles Jaffe, Director, Medical Informatics, AstraZeneca

9:10 CLINICAL TRIALS AND DATA MANAGEMENT

Anders Hansson

Anders Hansson, Vice President, Business Development, Clinitrac

  • Why is data management paramount to the success of clinical trials?
  • Current obstacles in data management and how, if at all, are they set to be overcome?
  • Likely changes to the data management procedure in the coming years
  • Regulatory issues in data management and how this affects clinical trials
  • 9:40 MANAGING CLINICAL TRIALS

    Chris Couch

    Chris Couch, Vice President, e-Services and Chief Operation Officer, Perceptive Informatics

  • Common problems in managing clinical trials
  • The role of CROs in managing clinical trials
  • Case study: successful trial management and unsuccessful trial management
  • Strategies to improve the management of clinical trials and the overall benefits of this
  • 10:20 IMPLEMENTATION OF CDISC STANDARDS

    Dr Herbert Noack

    Dr Herbert Noack, Head, Clinical Data Management & Senior Statistician, Covidence

  • How to implement is the real question – early or late, full or partly?
  • In data analysis and/or CDMS?
  • Smooth transition for legacy projects
  • The benefit of full CDISC compliance (internal, external)
  • 11:00 Morning Coffee

    11:20 DATA ACCURACY

    Dr François Peterlongo

    Dr François Peterlongo, Head, Data Standards & Services, Aventis

  • The role of data in your trials
  • How can data accuracy be ‘built in’ your processes and procedures
  • Pre-trial strategies to prevent inaccuracies
  • Performance measures
  • Frequent problems and solutions
  • 12:00 TRADITIONAL DATA CAPTURE TECHNIQUES

    Dr Uwe Trinks

    Dr Uwe Trinks, Chief Information Officer, Sentrx

  • How SAE report forms are traditionally processed
  • Problems with faxed forms
  • Case study – benefits of a browser-based SAE report form and knowledge management tool
  • 12:40 Networking Lunch

    14:00 TRANSFORMING EDC

    Tim Davies

    Tim Davies, Director, Corporate Development, CRF Box

  • Demonstrating the challenges in deploying data capture technologies into a live clinical trial environment and why the site teams often see an increase in workload
  • Examining how electronic patient diaries could improve the clinical trial process and reduce the burden of traditional EDC implementation
  • Case history – global phase III IBS trial with a top 10 pharma
  • Going back to basics - What data do we want to collect for our clinical trials? - At what point do we want to collect it? - Who do we want to provide the information?
  • 14:40 THE INTERNET AND CLINICAL TRIALS

    Selina Sibbald

    Selina Sibbald, Development Director, Quintiles

  • How the Internet is shaping clinical trials and data management
  • Security of data using the Internet – should it be a concern?
  • Brief overview of regulations affecting clinical trials using the Internet
  • Broader use of the internet outside of data capture
  • 15:20 Afternoon Tea

    15:40 INVESTING DECISIONS FOR ELECTRONIC SOLUTIONS

    Johnathan Burds

    Johnathan Burds, Regional Director – Northern Europe, First Consulting Group Life Sciences Europe

  • Which technologies will survive?
  • Is it better for clinical trial sponsors to partner with big or small vendors?
  • What are big pharma doing when considering a vendor?
  • Who makes the decisions about vendors?
  • The vendor selection process
  • 16:20 STUDY PROTOCOL DRIVEN DATA CAPTURE

    Dr Renno Schuurmans

    Dr Renno Schuurmans, Validation Project Manager, Innaphase

  • Accelerate bioanalysis and sample management
  • Time/ Concentration profiles
  • Pharmacokinetic (PK) analysis
  • Sponsor/ CRO interface
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Barry Burnstead

    Barry Burnstead, Program Management, Phase Forward

    9:10 KEYNOTE ADDRESS: IT IN CLINICAL TRIALS

    Hani Kamel

    Hani Kamel, Quality & Security Advisor, Novo Nordisk

  • The use of IT in the lifecycle of clinical trials
  • Problems associated with the use of IT in clinical trials and their impact
  • How to prevent, detect and solve these
  • New technologies and the opportunities they offer to improve data management
  • 9:40 PARTNERSHIPS AND COMMUNICATIONS

    Michael Kreuter

    Michael Kreuter, Director, Data Management, Project Planning & Resource Management, ICON Clinical Research

  • Clinical trial plans
  • Resolving data issues
  • Communication between data managers and clinical researchers
  • How breakdown in communications affect the trial
  • Key strategies to maintain relationships
  • 10:20 PROJECT DATA MANAGEMENT

    Julie Cartmell

    Julie Cartmell, Project Data Management Leader, AstraZeneca

  • Project management model
  • Approaches to project management
  • Scenario planning
  • Measuring success
  • 11:00 Morning Coffee

    11:20 ELECTRONIC PATIENT DIARIES

    Doug Engfer

    Doug Engfer, Founder, President & Chief Executive Officer, invivodata

  • Why use patient diaries?
  • How do electronic diaries excel over paper diaries?
  • How do electronic diary systems work?
  • How do electronic diaries enhance data accuracy and reliability?
  • Case studies: illustrations of some successful deployments
  • 12:00 PATIENT RECRUITMENT

    Dr G Paul Evans

    Dr G Paul Evans, Managing Director, Synexus

  • Avoiding delays in the clinical trial process
  • How can advertising and marketing improve your trial recruitment?
  • Using television and the Internet
  • Cost effectiveness of recruitment methods
  • Learning from case studies of successes and failures
  • 12:40 Networking Lunch

    13:40 INTEGRATING CLINICAL TRIAL MANAGEMENT & ELECTRONIC MEDICAL RECORDS

    Dr Charles Jaffe

    Dr Charles Jaffe, Director, Medical Informatics, AstraZeneca

  • Enhance patient/subject recruitment
  • Reduce physician opposition to computer data entry
  • Improve time and accuracy of query resolution management
  • Ease adoption of federal regulations and guidelines
  • Speed time to data lock and FDA submission
  • 14:20 CHARACTERISING AND DEFINING CLINICAL DATA

    Barry Burnstead

    Barry Burnstead, Program Management, Phase Forward

  • Overview of data systems now supporting clinical research and establishing context
  • Identifying areas or repeated storage and potential data conflict. Is reconciliation becoming an increased burden?
  • How can 21 CFR Part 11 guidelines be interpreted for all these data sources?
  • Current trends towards EDC and data warehousing and what they mean to the data flow and definition and opportunities for streamlining the process
  • 15:00 Afternoon Tea

    15:20 EDC EXPERIENCES AT H LUNDBECK

    Frank Jensen

    Frank Jensen, Head of Department, H Lundbeck

  • Starting up using new technologies in clinical trials
  • 16:00 VALIDATION OF CLINICAL DATA SYSTEMS

    Jeffery Taylor

    Jeffery Taylor, Validation Project Manager, PharmaSys

  • Overview of regulations
  • General methodologies for computer validation
  • Good validation practices
  • Change control
  • 16:40 DATA CAPTURE IN PHASE I CLINICAL TRIALS

    Robert Nichols

    Robert Nichols, Head, Data Management, Guy’s Drug Research Unit (Quintiles)

  • An overview of the world of phase I data management
  • What are the issues, what are the solutions?
  • Phase I experiences using a eCRF
  • Does the future have a cheaper, faster solution?
  • 17:20 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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