Monitoring


Clinical trials, ranging from simple to high complexity in assumption and structure, are initiated and conducted at acromion GmbH, realising a large scale of different therapeutic indications.

Our Team of educated and skilled clinical research associates has outstanding qualification and experience.

Our CRAs are managing investigative sites with personal interest and dedication.

Our monitoring activities include:

  • Identification and assessment of potential sites
  • Supporting technologies:
    to enhance the process of clinical site evaluation and local feasibility assessment (eSPA)
  • Collection and processing of essential documents
  • Preparation and conduct of initiation visits
  • Review and presentation of trial material
  • Training of site personnel
  • Preparation and conduct of periodic monitoring visits
  • Motivation of investigative staff
  • Control of protocol compliance
  • CRF-check and SDV
  • Monitoring of timely and complete SAE/AE reporting
  • Support in query resolution
  • Control of drug accountability, drug and non-drug supplies
  • Review and maintenance of investigator files
  • Audit preparation of trial sites and resolution of audit findings
  • Documentation of all activities
  • Processing and administration of investigator payments
  • Preparation and conduct of close-out visits

Key qualification factors for our monitoring team are:

  • Profound experience in clinical research
  • Intent accuracy and focused attention to details
  • Strong communication abilities
  • Highly developed organisational skills
  • Enthusiasm
  • Profound computer skills
  • Preparedness for on-site presence for a specified period of time
  • fluent in German and English and often a third language- e.g. French, Italian, Dutch, Spanish, Polish, Greek, Hungarian, Romanian, Corean – with profund skill in medical terminology

This fact reinforces GCP conform monitoring and source data verification of clinical data from your international clinical trials.

Your Contact

Julita Kelm-Wozniak
CRA Manager
acromion GmbH

Europaallee 27-29
50226 Frechen

Phone: +49 (0)2234-20 37 37-23
Fax: +49 (0)2234-20 37 37-9


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