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Sunshine Heart appoints CRO for US clinical trial: Alquest, Inc.
29 / 03 / 2007
Sunshine Heart (ASX: SHC) has appointed US clinical experts, Alquest Inc, to fast track the commencement of the multi-centre feasibility trial of the C-PulseT implantable heart assist device in North America.
Alquest is an internationally respected Contract Research Organization (CRO) specializing in medical devices. Alquest will work closely with Sunshine Heart's US-based clinical team to establish and monitor trials of the C-PulseT device in a number of large prestigious university based hospitals and regional referral hospitals.
Alquest will assist Sunshine Heart's US clinical trial team, including two recently appointed co-principal investigators, to manage the C-PulseT trials in the roles of site activation, clinical monitoring, data management and statistical analysis.
"We are confident that Alquest will provide the extensive clinical expertise required to commence the C-PulseT trial in the US later this year" said Ms Mary Beth Kepler, Sunshine Heart's US Clinical Director.
Alquest's extensive cardiovascular medical device experience, along with their personal experiences gained from the international medical device companies in the Minneapolis area, uniquely qualified Alquest to complement Sunshine Heart's clinical team.
President of Alquest, Ms Ann Quinlan-Smith, said "We look forward to assisting Sunshine Heart in achieving regulatory approval in a timely and quality fashion."
"The C-PulseT clinical experience gained in the current Australian/ New Zealand pilot trial provides a foundation for the US Feasibility trial" said Mr Donald Rohrbaugh, Chief Executive Officer of Sunshine Heart, Inc.
Alquest is an internationally respected Contract Research Organization (CRO) specializing in medical devices. Alquest will work closely with Sunshine Heart's US-based clinical team to establish and monitor trials of the C-PulseT device in a number of large prestigious university based hospitals and regional referral hospitals.
Alquest will assist Sunshine Heart's US clinical trial team, including two recently appointed co-principal investigators, to manage the C-PulseT trials in the roles of site activation, clinical monitoring, data management and statistical analysis.
"We are confident that Alquest will provide the extensive clinical expertise required to commence the C-PulseT trial in the US later this year" said Ms Mary Beth Kepler, Sunshine Heart's US Clinical Director.
Alquest's extensive cardiovascular medical device experience, along with their personal experiences gained from the international medical device companies in the Minneapolis area, uniquely qualified Alquest to complement Sunshine Heart's clinical team.
President of Alquest, Ms Ann Quinlan-Smith, said "We look forward to assisting Sunshine Heart in achieving regulatory approval in a timely and quality fashion."
"The C-PulseT clinical experience gained in the current Australian/ New Zealand pilot trial provides a foundation for the US Feasibility trial" said Mr Donald Rohrbaugh, Chief Executive Officer of Sunshine Heart, Inc.