08:30

Registration and Breakfast

09:00

 

Introduction and Aims of the Symposium

Rich Davies, Executive Director of Business Solutions, OmniComm Systems

09:10

 

 

 

 

 

 

 

 

Risk-Based Monitoring and Key Risk Indicators

Volume and complexity of clinical trials have grown dramatically over the past two decades. This has created new challenges in clinical trial operations as well as patient safety. As a consequence, the common practice of 100% source data verification (SDV) as part of the monitoring process has become a time-consuming and expensive exercise.   Recognising this challenge, the US FDA and the European Medicines Agency have recently issued guidance documents recommending a risk-based and data-driven approach to clinical monitoring. This approach, also referred to as targeted monitoring, helps allocating resources based on the risk level of study sites whilst maintaining patient safety as well as data quality and – integrity.   We’ll take a look at tools to facilitate Risk Based Monitoring - which provide a platform for flexible definition of risk categories and key risk indicators from all clinical and operational source data available, enabling rapid identification of outliers and trends in large volumes of data, and take action on issues identified based on defined suggested actions.

 Eric Herbel, President, Integrated Clinical Systems

09:45

 

 

 

 

 

 

A Pragmatic Approach to Risk-Based Monitoring

As the RBM movement continues to gain momentum, companies are now realising the difference between theory and practice. RBM is not a human challenge, a technology challenge or a process challenge - it is all of those things together. RBM needs to be applied in a holistic, well-coordinated manner from study design right through to the end of the monitoring period. The desired end goals of improved data quality, increased patient safety and reduced costs are all achievable but not without thought, planning and effort. This session will show a pragmatic approach to risk-based monitoring process, the integration of process and technology, and how this can be achieved using OPRA, the risk-based monitoring platform.

Duncan Hall, CEO, Triumph Research Intelligence Ltd

10:20

 

 

 

 

 

 

 

 

 

Risk Based Approaches to Clinical Development

Both EMA and FDA have issued guidelines on Risk Based Monitoring as an approach to increase the quality and save time by focusing on the highest risks for a given clinical study. Many companies are implementing strategies and collecting experience in ongoing trials.

Veloxis has worked with reduced SDV and targeted monitoring for many years and have just finalised a single centre clinical trial where a Risk Based Monitoring approach was utilised. The last data points are being entered into the eCRF and a clean database is expected in May. Current metrics show that the RBM set-up has saved time and increased the quality of the critical data checks. Furthermore a control sample of patients were reviewed according to the old-fashioned CRF page by page review which showed that all critical errors were found using the RBM approach.

Christoffer von Sehested, Director Clinical Operations, Veloxis Pharmaceuticals

10:55

Panel Discussion

11:15

Light refreshments

 

 

JReview-by-ICS-HighRes-trans

 

tri-logo

 

Veloxis_logo_RGB_300dpi

 

OmniComm-transparent

 


Denham Grove
Tilehouse Lane
Denham, Uxbridge
UB9 5DU


 

 

08:30

Registration and Breakfast

09:00

 

Introduction and Aims of the Symposium

Rohit Mistry, Director of Business Development, OmniComm Systems

09:10

 

 

 

 

 

 

 

 

Cost Effective Adoption of SDTM Standards

Our presentation will cover:

  • The importance of standardization for eCRFs and datasets. With a known set of questions, SDTM datasets and hence ADaM datasets can be standardized
  • Using a short list of EDC vendors allows edit check and workflow programming to be captured into the eCRF collection
  • Simulation of the eCRF / EDC dataset extracts and the importance of this for SDTM generation
  • Managing the SDTM creation process with multiple EDC vendors, the advantages of standardized eCRFs and CDASH
  • Machine readable data mapping specification reports to expedite eCRF annotation and improved data traceability reporting
  • SDTM to ADaM mapping, traceability reporting and standardized ETL code

Return on investment, reusing an eCRF brings with it SDTM and ADaM domains, ETL mapping and annotations. eCRF, SDTM and ADaM specifications reach 70% + reuse from study to study quickly (3+ studies on average)

Formedix

09:45

 

 

 

Clinical Analytics to drive operational efficiencies

A presentation of a wide variety of typical use patterns to more efficiently and effectively review clinical data for potential safety issues and outliers.   For many years, clinical data has been reviewed by exhaustive, 100% case by case data review, or line by line data listing review.   We’ll take a look a more effective use patterns being used by many companies and regulatory agencies in recent years to more efficiently and effectively review clinical data – focusing on patient level details only when identified from higher level visualizations.

Eric Herbel,President, Integrated Clinical Systems

10:20

 

 

 

 

 

 

 

Risk Based Approaches to Clinical Development

Risk-based monitoring (RBM) has become a clear imperative for the life sciences industry because of its compelling value proposition. Both FDA and EMA have provided strong endorsements for RBM, and industry groups including TransCelerate have provided additional guidance and support. Despite this, many organizations are struggling to move forward effectively. Several key factors have conspired against RBM progress. These include natural resistance to change - often supported by misperceptions about increased quality and regulatory risk – and a level of RBM over-engineering that results in complex, burdensome implementations especially during already pressure-packed study planning and set-up periods.

But the reality is that RBM does NOT need to be complicated or burdensome to your organization. Industry and RBM experts Andy Lawton (Boehringer-Ingelheim) and Steve Young (OmniComm Systems) will share their insights on RBM keys to success. The following topics will be covered:

  • The Growing Evidence in Favor of Risk-Based Monitoring
  • RBM Over-Engineering – Sifting through All of the Advice
  • Review the Keys to RBM Success

Rich Davies, Executive Director of Business Solutions, OmniComm Systems

10:55

Panel Discussion

11:15

Light refreshments

 

JReview-by-ICS-HighRes-trans

 

Formedix_logo_MAIN_RGB

 

OmniComm-transparent


Renaissance Paris Arc de Triomphe Hotel
39 Avenue de Wagram
Paris, 75 017 France

 

 

08:30

Registration and Breakfast

09:00

 

 

Introduction and Aims of the Symposium

Rohit Mistry, Director of Business Development, OmniComm Systems

09:10

 

 

 

Risk-Based Monitoring and Key Risk Indicators

Volume and complexity of clinical trials have grown dramatically over the past two decades. This has created new challenges in clinical trial operations as well as patient safety. As a consequence, the common practice of 100% source data verification (SDV) as part of the monitoring process has become a time-consuming and expensive exercise.   Recognizing this challenge, the US FDA and the European Medicines Agency have recently issued guidance documents recommending a risk-based and data-driven approach to clinical monitoring. This approach, also referred to as targeted monitoring, helps allocating resources based on the risk level of study sites whilst maintaining patient safety as well as data quality and –integrity.   We’ll take a look at tools to facilitate Risk Based Monitoring - which provide a platform for flexible definition of risk categories and key risk indicators from all clinical and operational source data available, enabling rapid identification of outliers and trends in large volumes of data, and take action on issues identified based on defined suggested actions.

Eric Herbel, President, Integrated Clinical Systems

09:45

 

 

 

A Pragmatic Approach to Risk-Based Monitoring

As the RBM movement continues to gain momentum, companies are now realising the difference between theory and practice. RBM is not a human challenge, a technology challenge or a process challenge - it is all of those things together. RBM needs to be applied in a holistic, well-coordinated manner from study design right through to the end of the monitoring period. The desired end goals of improved data quality, increased patient safety and reduced costs are all achievable but not without thought, planning and effort. This seminar will show a pragmatic approach to risk-based monitoring process, the integration of process and technology, and how this can be achieved using OPRA, the risk-based monitoring platform.

Duncan Hall, CEO, Triumph Business Intelligence Ltd.

10:20

 

 

 

 

 

 

 

Risk Based Approaches to Clinical Development

Risk-based monitoring (RBM) has become a clear imperative for the life sciences industry because of its compelling value proposition. Both FDA and EMA have provided strong endorsements for RBM, and industry groups including TransCelerate have provided additional guidance and support. Despite this, many organizations are struggling to move forward effectively. Several key factors have conspired against RBM progress. These include natural resistance to change - often supported by misperceptions about increased quality and regulatory risk – and a level of RBM over-engineering that results in complex, burdensome implementations especially during already pressure-packed study planning and set-up periods.

But the reality is that RBM does NOT need to be complicated or burdensome to your organization. Industry and RBM experts Andy Lawton (Boehringer-Ingelheim) and Steve Young (OmniComm Systems) will share their insights on RBM keys to success. The following topics will be covered:

  • The Growing Evidence in Favor of Risk-Based Monitoring
  • RBM Over-Engineering – Sifting through All of the Advice
  • Review the Keys to RBM Success

Rich Davies, Executive Director of Business Solutions, OmniComm Systems

10:50

Panel Discussion

11:15

Light refreshments

 

JReview-by-ICS-HighRes-trans

 

tri-logo

 

 

OmniComm-transparent


Hilton Basel
Aeschengraben 31
4051 Basel, Switzerland