PUBLICATIONS
At Qualiance, we believe in knowledge sharing to progress the Industry and regularly speak at events and conferences. We try to publish our work at every opportunity. Please find below our contribution to the community.
DATA ANONYMISATION & SHARING
Clinical Document Anonymization and Disclosure, a Global Perspective – JM. Ferran (CBI Data Disclosure Conference, Coral Gables, 2020)
This presentation provides an overview of regulatory requirements across agencies with regards to data sharing, reviews the FDA Clinical Data Summary Pilot, and provides some insight into 2020 main announcements to come in the field.
European Medicines Agency Policy 0070: An Exploratory Review of Data Utility in Clinical Study Reports for Academic Research – JM. Ferran & S. Nevitt (BMC Medical Research Methodology, 2019)
This publication features the highlights of a review of 13 academic research reports, with the goal to better understand Data Utility in anonymised CSRs. Their different research purposes have been analysed and classified against the required data to support them.
European Medicines Agency Policy 0070: An Exploratory Review of Data Utility in Clinical Study Reports for Academic Research – S. Nevitt & JM. Ferran (6th SAS CTDT Forum, Heidelberg, 2019)
This presentation features the highlights of a review of 13 academic research reports, with the goal to better understand Data Utility in anonymised CSRs. Their different research purposes have been analysed and classified against the required data to support them.
EMA, Health Canada, FDA and PMDA: Four Agencies Tackle Data Sharing. Synergies and Differences – JM. Ferran & L. Roberts (PHUSE US Connect, Baltimore, 2019)
There are various policies around Data Sharing of submission documents which are effective or in preparation. This paper explores how four agencies' policies differ or align in terms of processes and anonymisation requirements.
Anonymising Clinical Data –Key Principles, Methods and Considerations – JM. Ferran (EFSPI/PSI Webinar, 2017)
This Industry presentation features key principles around risk quantification, use of different disclosure contexts and reference populations. It also provides insights into the PHUSE De-Identification Standards for SDTM 3.2.
Integrating the New EMA Requirements on Public Disclosure in the Study Conduct Process – JM. Ferran (PHUSE SDE, Copenhagen, 2016)
This presentation compares requirements between ClinicalTrials.gov and EudraCT and discusses the process of publishing study results in multiple registries. It also tackles the future of Policy 0070 and how sponsors could consider updating their processes.
PHUSE De-Identification Working Group: Providing De-Identification Standards to CDISC Data Models – JM. Ferran et al. (PHUSE Annual Conference, Vienna, 2015)
This conference paper explains in more details the different principles of the PHUSE De-Identification Standard for SDTM 3.2, their rationale and how to use them in practice. It is authored by five key members of the PhUSE Data Transparency Working Group.
Data De-Identification: New Challenges for the Data Scientist – JM. Ferran (PHUSE SDE, Copenhagen, 2015)
This presentation features examples of re-identification attacks, key principles on risk quantification and use of reference populations. A research request also illustrates how researchers use shared data.
Data Transparency: Important Considerations for Data De-Identification – JM. Ferran (PHUSE SDE, London, 2014)
This presentation discusses Data Sharing requests handled through a portal and details related processes, along with basic "safe-harbour" data de-identification principles to consider.
STATISTICAL COMPUTING ENVIRONMENTS
R and SAS working together – DNR’s experience moving to LSAF 5.3 – P. Vervuren & JM. Ferran (PHUSE EU Connect (Virtual), 2021)
This conference presentation summarises the approach and findings in implementing R within LSAF 5.3 at Danone Nutricia Research over a period of 9 months in 2021. Qualiance co-led this project, and this paper highlights the approach we followed with Danone, as well as...
Manage TFLs Development in Life Science Analytics Framework 5.3 using SAS and R code – JM. Ferran & S. Rogiers (PHUSE EU Connect (Virtual), 2020)
This conference presentation highlights the findings from a prototype in LSAF 5.3 around the management of both SAS and R programs using the new TFL metadata module in combination with workflows.
Checking the Completeness of Validated SAS Programs in LSAF – H. Ament & JM. Ferran (PHUSE EU Connect (Virtual), 2020)
This conference presentation outline the implementation of a simple Development Life Cycle in LSAF, supporting tools to check dependencies and report on status and how it is used at Danone Nutricia Research.
Migrating to LSAF – The Danone Nutricia Research Journey – P. Vervuren & JM. Ferran (PHUSE EU Connect, Amsterdam, 2019)
This paper summarises an LSAF implementation run with Danone Nutricia Research over a period of 10 months in 2018. Qualiance co-led this project, and this paper highlights the approach we followed with Danone, as well as some recommendations and learnings.
Managing Program Development Life Cycles in SAS LSAF – JM. Ferran & B. Klein (PHUSE Utrecht SDE, 2019)
Managing program development life cycles efficiently is often a challenge in clinical study reporting. This conference presentation details the implementation of a simple Development Life Cycle in LSAF and how it is used at Ferring Pharmaceuticals.
Managing Program Development Life Cycles in SAS LSAF – JM. Ferran (PHUSE US Connect, Raleigh, 2018)
Managing program development life cycles efficiently is often a challenge in clinical study reporting. Manual processes often lead to inconsistencies and audit findings. This conference paper details the implementation of a simple Development Life Cycle in LSAF.
Review and Highlights of the 2016 Survey of the Top 20 Biopharmaceutical Companies’ Statistical Computing Environments – JM. Ferran & J. McDermott (PHUSE SDE, Basel, 2017)
This presentation features main findings and trends from a survey conducted for Novartis with 15 of the top 20 pharmaceutical companies about their Statistical Computing Environments, their usage and evaluation.
SDD APIs: Extending the Capabilities of SAS Drug Development – JM. Ferran (SAS SDD Briefing, Copenhagen, 2014)
This presentation features the SDD APIs and implementation examples, as well as highlights from the latest API release including possible applications.
Developing an Integrated Platform: Getting the Best out of Several Technologies – JM. Ferran (PHUSE Annual Conference, Brussels, 2013)
This presentation features the technical design of an application for Standards Management built for a top 5 pharmaceutical on top of LSAF (formerly SAS DD), where Java, SAS and Oracle technologies were all used and integrated to work at full strength.
ANALYTICS
Pregnancy outcomes in women receiving growth hormone replacement therapy enrolled in the NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program – Biller et al. (Pituitary, 2021)
This analysis of pregnancy outcomes in women receiving growth hormone is based on the pooled analysis of the NordiNet IOS (Europe) and ANSWER (US) Paediatric Growth Hormone Programs. Qualiance (Acknowledgement) provided statistical support to produce the underlying...
Long-term safety of growth hormone treatment in childhood: Two large observational studies NordiNet ® IOS and ANSWER – Sävendahl et al. (JCEM, 2021)
This long-term safety analysis is based on the pooled analysis of the NordiNet IOS (Europe) and ANSWER (US) Paediatric Growth Hormone Programs. Qualiance (Acknowledgement) provided statistical support to produce the underlying analyses.
Long-Term Effectiveness and Safety of Childhood Growth Hormone Treatment in Noonan Syndrome – Roher et al. (HRiP, 2021)
This manuscript is based on the pooled analysis of the NordiNet IOS (Europe) and ANSWER (US) Paediatric Growth Hormone Programs for patients diagnosed with Noonan Syndrome. Qualiance (Acknowledgement) provided statistical support to produce the underlying analyses.
Growth Hormone Replacement in Adults: Real-World Data from Two Large Studies in US and Europe – Weber et al. (GHIR, 2020)
This manuscript is the main publication for the pooled analysis of the NordiNet IOS (Europe) and ANSWER (US) Adult Growth Hormone Programs. Qualiance (Acknowledgement) provided statistical support to produce the underlying analyses.
Treatment of Children with Growth Hormone in the US and Europe: Long-term Follow-up from NordiNet IOS and ANSWER Program – Sävendahl et al. (JCEM, 2019)
This manuscript is the main publication for the pooled analysis of the NordiNet IOS (Europe) and ANSWER (US) Paediatric Growth Hormone Programs. Qualiance (Acknowledgement) provided statistical support to produce the underlying analyses.
Prototyping the Automation from SAP to Compiled Outputs – JM. Ferran (PHUSE SDE, Copenhagen, 2012)
This presentation features a solution that was built for a customer's regulatory submission to automate using the Statistical Analysis Plan, the production of 2,100+ outputs for an Integrated Summary for Safety (ISS) of 50+ studies.
Writing Standard Programs Your People Will Use and Love! – JM. Ferran (PHUSE Annual Conference, Brighton, 2011)
This conference paper covers different strategies to develop and test standard programs involving users, with the goal to reach maximum user-friendliness and drive usage. The development life cycle of such components is also discussed in details.
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