Ecron ACUNOVA
 
 
 
Therapeutic Experience
 

Therapeutic Experience



With a 28 year track record of successful Phase I – IV studies EA has deep knowledge of study set-up, conduct and evaluation of clinical projects in various therapy areas.

EA has performed a considerable number of studies in various therapeutic areas.

     

Success in Oncology Projects



Long cooperation between EA and investigators in global cancer centers and oncology networks facilitates
• Fast patient recruitment
• high quality data

Management of long-term studies by the same EA core team (e.g. 8 year long Non Hodgkin lymphoma trial) strengthens our relationship with the participating sites and leads to one-time, on-budget studies.

Performance of studies for targeted oncological therapies

Therapeutic Area No of Studies
Cardiovascular Diseases 34
Dermatology 13
Ear, Nose, Throat 5
Endocrinology 22
Gastroenterology 19
Immunology 3
Infectiology 13
Metabolic Disorders 6
Muscoloskeletal System 15
Nephrology 11
Neurology 35
Nutrition/Nutraceuticals 12
Obstetrics & Gynaecology 7
Oncology/Hematology 86
Ophthalmology 24
Respiratory 18
Urology 2
Anti-Inflammatory 1
Vaccines 3
Infectious Diseases 2
Other 2
Total 333*


*including No of Studies
Diagnostic Imaging 35
Medical Devices 14
Pediatric 19
Nutrition 11
Stem Cells Therapy 11
  Case Studies

Diagnostic Imaging - Quality


EA enrolled 902 patients for a Phase III Breast Cancer study in 14 countries across Europe, Asia and Americas.  The enrollment was completed and the sponsor successfully passed the FDA audit.

Pulmonology - Continuity


A six year, full-service COPD trial was managed by the same EA core team for the entire project!

EA provided the majority of the 572 trial sites from western and eastern Europe, including the highest enrolling sites.
Marketing renewal from the German regulatory authority was given based on this trial.

Immunology - Speed


In a Phase III study for inflammatory autoimmune disease EA completed patient enrollment in 11 months, 7 months faster than the original estimate of 18 months.

Women’s Health - Oversight


EA successfully performed a series of three parallel hormone replacement therapy studies (1 safety study including biopsy, 2 efficacy studies) in Germany and CEE with > 1.200 patients at > 180 sites.

Epilepsy - 'First to File' Registration


EA conducted a patient PK study with bio-analysis for an epilepsy drug at 5 sites. The sponsor was given First -to-File registration in USA.

EA Plays Sponsor Role


EA is acting as Sponsor for a group of MAHs in a Phase IV trial which was requested by EMA. The study is performed by EA in 8 countries in Europe, Asia and US in 30 sites with 350 patients planned.

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Therapeutic Experience
Success in Oncology Projects
Case Studies
 
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