Ask Aabenhus Email & Phone Number

Copenhagen Area, Capital Region, Denmark

NEXT Partnership is an innovative public-private partnership, where we set new standards for the collaboration between public and private sector within early phase clinical trials. My responsibilities include:- Link between Next Core and clinical Centres and departments- Process optimization of compentent authority interactions, contracts, feasibilities and patient recruitment- Follow-up on goals and definition of center criteria- Financial reporting- Prepare and follow-up on Steering group meetings- Involvement of communication and legal responsible partners - Marketing towards the global pharmaceutical industry- Clinical trials pricing transparancy- Facilitation of patient databases across disease areas

Scion-Dtu, Kgs. Lyngby, Denmark

Responsible for all aspects of clinical program management and study management of diagnostic medical devices within cardiology.

Copenhagen Area, Denmark

Clinical strategy and study design responsibile, medical writing. Process improvements.

Denmark

Leadership and study management of the phase III/IV COPD study, REACT, recruiting almost 2000 patients across 220 sites in 21 countries incl. Australia, Brazil, Europe, Russia, South Africa, South Korea and Canada. Recruitment finalized. Achieved substantial cost reductions through in CRO contract negotiations. Change management; keeping momentum while the study team disintegrates and a new one takes over. See http://clinicaltrials.gov/show/NCT01329029. Safety Management Team member, Pharmacovigilance MHRA inspection team member and GCP SOP reviewer and author. Recruitment & Retention work stream guideline finished. Filed a developments proposal for a new compound in connection with a global innovation initiative at Takeda.

Denmark

Leadership and study management of the phase III/IV COPD study, REACT, recruiting almost 2000 patients across 220 sites in 21 countries incl. Australia, Brazil, Europe, Russia, South Africa, South Korea and Canada. Change management; realizing a recruitment catch-up on the REACT trial while taking over a disintegrating trial team across multiple locations Managed studies within budgets and ensured Sponsor change and Sponsor name change of REACT. See http://clinicaltrials.gov/show/NCT01329029. Leadership and study management of phase III neurosurgical study, TASALL, recruitment more than 700 patients across 11 countries in Europe and Russia. Authored the protocol, ensured initiation and recruitment according to plan. Developed training device and filed patent hereon. Achieved substantial cost reductions in CRO contract negotiations. See http://clinicaltrials.gov/show/NCT01355627. Clinical Sub-Team member, Safety Management Team member, Recruitment & Retention work stream member, FDA inspection team member, Core Project Team substitute and GCP SOP reviewer and author.Suggested a strategically new approach to management for the design of clinical trials.

Responsible for overall clinical trial management incl. selection, contracting and management of CROs and other external parties, safety reporting etc. for: - Primovax (Phase III trial, pancreatic cancer) since May 2006.- Heptovax (Phase II trial, liver cancer) from Dec. 2005 - Apr. 2006.- Telovac (phase III trial, pancreatic cancer) from Aug. 2005 - Apr. 2006.

Responsible for: - Overall clinical trial management and monitoring of wound care trials for the Contreet project (class three medical device).- Clinical development plans for the Healing Enhancer project (class three medical device).

Responsible for clinical monitoring of wound care trials for class three medical devices.

Responsible for clinical trial management of wound care trial for the Vacuseal product (negative pressure therapy) and the clinical monitoring of wound care trials for the Contreet product (class three medical device).

Eba, Management

Master Of Science (M.Sc.), Pharmacy