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Sunday, 24 September 2017
Conducting trials in eastern and southeastern-EU?

While committed to maintain the highest possible degree of cost- and time-efficiency, we progressively shifted the core of our trial activities to central, eastern- (CEE) and mostly south-eastern-EU (SEE).

In order to offer our sponsors the best possible trial accommodation (country, site, investigator), we do not maintain our own study clinics. Instead we have established several dedicated alliances with well-qualified experienced trial sites throughout the region.

Since we have many years of experience working in CEE- and SEE-countries we are quite well aware of the many soft- and hardware constraints involved.
In order not to compromise our high quality standards of our services, we took several precautions to overcome these constraints:

  • All trials are managed by a senior scientist (Project Manager) from ACPS Mainz-Kastel irrespective of the site of conduct.
  • The Project Manager visits the site at all critical stages. Dr. de Mey for instance, visits Sofia for 4-5 days every month.
  • The Project Manager is assisted on-site by experienced local ACPS-staff (Clinical Research Associates and Clinical Research Physicians).
  • ACPS CRA & CRP participate in a full 2-year training program before operating autonomously; however, at all times they can rely on the dedicated support of senior staff from ACPS Mz-Kastel
  • ACPS provides its trial sites – as needed – with all necessary equipment: sampling materials, high-sensitivity thermometers (T° monitoring of clinical trial materials and samples), conventional and digital ECG, ambulatory 24h ECG- and BP-monitoring, impedance cardiography, skin conductance, pupilometry, etc. Additionally, ACPS provides working instructions in local language, in-depth training before start of the study and meticulous monitoring of the orderly use of these methods during the study.

 

Hence, ACPS does not adopt a 'convenience' approach only to use these facilities as blood and data collectors. Instead, we do use our CEE- and SEE-sites as responsible research partners with direct access to the full scientific scope of the study planning, conduct and reporting.

Last Updated (Thursday, 15 September 2016)

Applied Clinical Pharmacology Services

* Philippsring 11 * 55252 Mainz-Kastel * Germany * phone: +49/61 34 - 180 467 or 469 * fax: +49/61 34 - 180 468 *


ACPS International Ltd.-Bulgaria

* 1113 Sofia * 15 "Kosta Lulchev" Str., ap. 9 * phone: +359/2 979-7970 * fax: +359/2 979-7971 *