Founded in 1985, we offer international services, from early conception of a trial to final report.
Starting with 3 employees and a focus on data management and analysis, we already extended our services throughout the first 10 years including other key services as project management and monitoring.
Since the 90s our team consists of app. 25 dedicated, highly sophisticated employees.
Please see Historical Milestones for more information.
In 2015 we were part of an inspection program driven by German local authorities comprising scrutinizing visits at sponsor, CRO, lab and different investigational sites. The CRO inspection resulted in only minor findings for our Munich office. The corresponding corrective and preventive action plan provided was accepted by the inspectors straightaway and all findings could be remedied within a few weeks.
The sponsor was very pleased with the overall outcome of the inspections.
Budesonide granules EMA approved for Crohn's Disease
Our study with 59 sites in 10 countries all over Europe results in an EMA approval for Budesonide granules in Crohn´s Disease an incurable disease leading to diminished quality of life.
Oral daily granules, as treatment for those with Crohn´s disease achieved therapeutic benefit for more than 90% of patients in each group.
Due to sophisticated coordination by our team the demanding timelines were met.
Sponsor expresses intent to recommend based on data review
In a safety and efficacy dose-finding study over 12 countries with 44 sites our medical advisor continuously reviews data which leads to a successful running clinical trial evaluating a promising newly developed drug in a rare liver disease without available standard therapy.
Our sponsor repeatedly expressed intent to repurchase and recommend based on our skills and expertise.