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.
Clinical Supply Manager:
Responsible for activities in the packaging, labelling and distribution of investigational medicinal products (IMP) and other products. The consultant will ensure that the trial products will be packed, labelled, released and distributed according to the timelines in collaboration with the clinical team, CMC, the packaging facility and QA.
Provides an independent and risk-based GCP audit service, which will focus on the areas of high risk to the company/organisation’s quality system, taking into account the applicable regulatory requirements.
Responsible for coordinating all activities with the IRT vendor in the process of setting up the IWRS/IRT for the trial.
Monitor/Clinical Research Associate:
Responsible for all aspects of the trial site monitoring services; for example selection of investigational trial site, support to patient recruitment, training, site initiation, monitoring during the trial and site closure. Represent the corporation by maintaining collaborative relationships with different stakeholders.
Provides an independent risk-based pharmacovigilance audit service, which will focus on the areas of high risk to the company/organisation’s quality system, taking into account the applicable regulatory requirements.
Responsible for handling of safety data and ICSR including MedDRa coding and medical evaluation of the case – reviewing of the protocol and the Case Report Form (AE form) in order to ensure the regulatory requirements are met.
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.
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