During the course of a clinical trial, changes often occur that need to be responded to quickly and appropriately in order to keep the project on track.
You need a qualified, experienced and flexible freelance consultant to ensure that the project continues without delay and loss of quality, or that a clinical trial is planned and started efficiently from the outset.
With more than 15 years of experience, AE Consulting offers you competent support in the planning and implementation of clinical studies.
Take advantage of the independence and flexibility of AE Consulting. We complement your team and ensure optimization through continuous, professional support of the respective project from a single source.
We offer the following services independently,
prompt and flexible:
Implementation of clinical monitoring according to ICH-GCP guidelines:
Support in study site qualification visits
Adaptation and translation of patient information sheets and consent forms
(if required)
Selection, initiation
and monitoring visits
(including all necessary documentation)
Recruitment of
additional study sites
(if required)
Support / takeover of
all submission processes to the necessary authorities
Takeover of started
studies in different
project phases
Education/training
of study staff
Participation in study /
project meetings
Care of Investigator
Site File / Trial Master File
Close-out visits
Organization of Investigator meetings
Collaborate with study sites to ensure accurate and timely reporting of safety issues (adverse events/adverse reactions such as AEs/SAEs/SUSARs, etc.) and follow-up.
