We provide consultancy service with high quality within following area:
- Clinical Quality Manager: responsible for SOP writing, GAP analysis, audit and inspection follow-up, training, handling of deviations etc.
- Safety Adviser: responsible for handling of safety data and ICSR including MedDRa coding and medical evaluation of the case – reviewing of the protocol and the CRF (AE form) in order to ensure the regulatory requirements are met.
- Clinical Supply Manager: responsible for activities in the packaging and labelling of investigational medicinal products (IMP) and other products. The consultant will ensure that the trial products will be packed, labelled and released according to the timelines in collaboration with the clinical team, CMC, the packaging facility and QA.
- IWRS/IRT coordinator: responsible for coordinating all activities with the IRT vendor in the process of setting up the IWRS/IRT for the trial.
We would like to collaborate with experienced freelancers within clinical research with high quality mindset, reliability and flexibility. Several companies need experienced consultants for tasks or projects to be solved within a short or longer period.
If you are interested in becoming member of our freelancer database, please register your CV in our database. We will contact you when there is a match.
Register your CV