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PSDM Upcoming Events

PSDM Website make-over

The PSDM website has been completely re-designed. See www.psdm.nl instead.

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PSDM board vacancy

The PSDM is currently looking for an additional member to join their board (Data Management area).

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Recent PSDM Event:

Implementation of CDISC standardization - Pragmatic Approaches, Monday 14 Sep 2015,

Program


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Risk-based Monitoring: opportunities and challenges in clinical development

RECENT EVENT 
 

The PSDM group of the Biometrics Section (BMS) of the Netherlands Society for Statistics and Operations Research (VVS/OR) organised the event:

Risk-based Monitoring:
opportunities and challenges in clinical development


Monday September 2nd, 2013
hosted by Astellas, Leiden

 

 

 

Risk-based Monitoring: changing the position of Biometrics in clinical development

 

Current On-site Monitoring practices are frequency-based, conform to a prescribed monitoring visit schedule, and provide generalized quality control at investigational sites. Although this practice does provide a level of control, advances in risk-based approaches and technology provide an opportunity for a more holistic and proactive approach through Off-site and Central Monitoring and a targeted approach to On-site Monitoring (1). In 2011 both the FDA and EMA released guidance papers in which the Regulatory Agencies encourage implementation of modern, risk-based approaches for clinical study oversight activities, that focus on critical study parameters (2, 3). The almost concurrent release of the Agencies’ guidance documents has triggered numerous discussions among clinical research operatives and peers, including sponsors of drug and device clinical research, contract research organizations and academic clinical research organizations (4).

Technology, data integration, and analytics are all key enablers for successful implementation of risk-based monitoring strategies. Relevant analytics must be developed to enable rapid identification of outliers and trends in large volumes of data (1). Statistics and Data Management functions are therefore key to efficient risk-based monitoring approaches. This provides opportunities for our functions, but also requires a changing mindset towards the role of biometrics teams in the execution of a clinical study. Our speakers, experts and key opinion leaders in their field of work, will present their views on Risk-based monitoring approaches, current implementation practices and the role of biometrics therein. They will also discuss opportunities and challenges for our functions as well as for clinical development teams as a whole.

References:
1) TransCelerate BioPharma Inc.; Position Paper: Risk-Based Monitoring Methodology; 30-May-2013
2) Food and Drug Administration; Guidance for Industry Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring; Draft Guidance 24-Aug-2011 www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf
3) European Medicines Agency; Reflection paper on risk based quality management in clinical trials; draft guidance 31-May-2011 www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500110059.pdf
4) eClinical Forum Risk Based Monitoring Taskforce; Risk-Based Approaches: best practice for ensuring clinical data quality; 15-Sep-2012

 

Final Program
(for abstracts and presentations see table)

REGISTRATION closed

 

12:30

Registration, coffee & tea
13:00

Case study: Risk-based Monitoring implementation - impact on Data Management and other functions & TransCelerate BioPharma initiative
Andy Lawton, Global Head of Data Management,

Boehringer Ingelheim Ltd, United Kingdom

abstract    presentation

14:00 

Risk-Based Monitoring: from source data verification to source data review
Frederic Hlavac, Global Studies Manager,
F. Hoffmann-La Roche Ltd, Switzerland

abstract     presentation

14:45  Coffee break
15:00

Detection of fraud and misconduct using statistical techniques
Hein Fennema, Director Late Development Statistics,
MSD, The Netherlands

abstract

15:45 

Plenary discussion: how will Risk-based monitoring change the field of biometrics and clinical development?

16.15

Annual PSDM Meeting
Egbert Biesheuvel, PSDM Chair
PSDM board members

17:00

Closure & Drinks

Hosted by Astellas, Leiden, the Netherlands.
Price: €50
Route description