Regulatory Affairs Clinical Services

WHO WE ARE


We are freelance contractors all with over 10 years experience in the pharmaceutical, biotech, clinical reseach organisation, semi-public organisation or industry primarily in the conduct of clinical research.


We are mainly a great asset if you wish to assess how strong your documentation is (gap analysis) whether it being the concept of your clinical trial according to implementation of ICH E6 R2, practical implementation of the clinical trial protocol (project management and statistics) or the supporting quality of the investigational medicinal product (and background therapy; placebo) to be tested.

WHY CHOOSE US?


We work swiftly and transparent with our clients to optimise the transfer of information to indentify the correct set-up of a clinical trial mainly regarding choosing committed sites and investigators (quality, high enrollment) based on past experience, in countries which provide reliable data at the best quality/cost ratio in the shortest possible timeframe.

OUR HISTORY


Founded

2017


Coverage

Global; primarily EU (Scientific and Procedural Advice), Austria, Denmark, Germany & Switzerland


OUR VISION


Reduce Cost

Improve Assessment Speed

Optimise Project Managemnt

Ensure Realistic Statistic

USEFUL INFO


Contact: Use the Contact For Information