Our Clinical Trial

Flamel’s Once Nightly Sodium Oxybate Clinical Trial: REST-ON

Patient Advisory Group

Patient Partnership and Engagement

Putting the Patient First

Flamels' Commitment to Safeguarding the Rights of Patients in its Clinical Trials
Our Commitment To You

1. Flamel is committed to ensuring that the safety, rights and wellbeing of all study patients is a matter of organizational priority.

2. Flamel Technologies respects that clinical trial participation is entirely voluntary. Study patients can withdraw from a clinical trial at any stage time, for whatever reason and without having to justify their decision.

3. Flamel Technologies, as a matter of policy, embeds all GCP, Legal and Regulatory requirements within its operational framework to achieve research outputs which are both ethical and scientifically sound.

The following are the key best practice measures Flamel implement for clinical trial activity:

  • In order to ensure compliance with ethical standards the Flamel FT218 clinical trial protocol was developed in line with the “Declaration of Helsinki”, a set of ethical standards for research involving beings, human samples or identifiable data. This was devised by the World Medical Association.

  • The trial design was developed based on advisory from experts in the field of sleep medicine, patients and statistical experts to draw up the best possible design for this study.

  • Putting in place all necessary regulatory e.g. FDA clinical trial approvals before the study starts. If there is any change or if new data emerge during the clinical trial the regulatory body as well as patients will be notified as required.

  • Putting in place all necessary ethical approvals from the appropriate Institutional Review Board(s)(IRB)/Research Ethics Committee (REC) before the study starts. If there is any change or if new data emerge during the clinical trial the IRB/REC body is notified as required.

  • All clinical units and associated physicians, nurses, study coordinators, sleep technologists are pre-approved in terms of their qualification, training and experience before they can work on this study.

  • Both Flamel and all of its partners that work on this study will do so in accordance with all regulatory and best practice guidance and requirements.

About Flamel Ireland Limited

Flamel Ireland Limited is part of the Avadel Group of Companies. AVADEL is new and unique kind of pharmaceuticals company that changes lives through patient-focused innovation. We make medicine more meaningful.

Specializing in the optimization of compounds, we strive to develop and commercialize products that are safe, effective and easy to take, thereby helping patients adhere to their prescribed medical treatment and see better results.

Our TEAM

Siobhan O’ Daly

Director of Clinical Development, Avadel.
Siobhán has almost twenty years experience running clinical trials. She has been responsible for the global set-up and running of the FT218 Clinical Trial. Siobhán led the establishment of the PAG with the Narcolepsy Network USA and currently working with an EU PAG group.

Maire Fenton

Clinical Project Manager, Avadel.
Maire is an experienced Project Manager. Maire is responsible for the day to day global management of this trial ensuring strict compliance with all regulatory, ethical and best clinical practice requirements. Maire has directly implemented feedback from the PAG to ensure trial alignment with the direct needs of patients.

Susan Dowd

Clinical Trials Lead, Avadel.
Susan provides critical operational support for this study. Specifically Susan works very closely with the FT218 Patient Advisory Group and has been instrumental in its coordination and ongoing communications.

Norah Cassidy

Clinical Research Associate I
Norah provides critical operational support for this study. Additionally, Norah works very closely with the FT218 Patient Advisory Group team.

Jennifer Allen

Clinical Research Associate
Jennifer is new to the REST-ON Team. Jennifer is providing support in clinical roll out activities to further support high quality standards in study execution.

David Monteith

Vice President of Research and Development.
David has over 20 years leadership experience in heading up Pharmaceutical Research & Development activities. David is closely aligned with the PAG development activities, and considers the PAG group to be integral to any R&D operation to ensure the end product is aligned with actual patient need.

Cendrine Grangeon

Project Manager, Pharmaceutical Development, Avadel.
Cendrine is an accomplished scientist who provides leadership in pharmaceutical development activities for the FT218 clinical trial. Cendrine is a keen advocate of patient partnership and will provide critical input to the PAG evolution.

Dr. Tom Roth

Clinical and Scientific Expert in Narcolepsy, Advisor to Avadel.
Dr. Roth is both a renowned and respected expert in Sleep. Dr. Roth brings with him over 40 years of experience and expertise to the FT218 Clinical Trial team. Dr. Roth is actively involved with the FT218 PAG.

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Links

Useful links
Go to Narcolepsy Network

Narcolepsy Network

Go to European Patients’ Academy

European Patients’ Academy

Go to Narcolepsy UK

Narcolepsy UK