Quality

We follow our own ICH and EU Directive compatible SOPs, updated bi-annually. We are also able to operate also under the client’s SOPs. QA system ensures that required quality level of tasks and results is attained during performance of clinical trials and other activities of the company. The basis is given in Quality Manual. A general QA plan is prepared and summarized in the yearly issued Quality Objectives. The plan covers activities and procedures within QM system, SOP management, training, care of staff development, project management, QC system (including plan of co-monitoring visits and internal audits), claim management, IT development and other activities. The plan is prepared by the Quality Manager and approved by the Managing Director.

A quality management system in the frame of clinical trial is implemented on the project-specific basis by Quality Manager in cooperation with Project Manager and Managing Director at the beginning of the particular trial. Fulfillment of the plan, as well as its modifications resulting from the actual needs of the project are followed on regular basis by Pharmnet Quality Manager.  

Continuous Professional Development

Our staff participates in a continual training within and outside, the company. Pharmnet training methods passing the “company memory” to all employees qualify the staff for providing advice and support to Sponsors / Investigators in unexpected and atypical situations. Scientific methodology training qualifies the CRAs for making decisions with a full awareness of their reason and ultimate impact on the study.

The company training system comprises 5 types of training programs:  

• New employee (CRA) training – approximately 3 months training consists of seminars on GCP, SOPs, local legislative and monitoring skills, study of assigned materials and practical training by experienced monitor - supervisor. The practical training involves work on at least 2 projects and is customized to each employee based on his/her previous experience.
• Regular training: Seminars and workshops for employees are organized every 1 or 2 months. Topics on GCP, local legislative updates, medical issues and other topics important for the work of CRAs are chosen.
• Clinical study specific training – in the beginning of each clinical trial a study specific training is organized to familiarize the staff with the relevant field of medicine and study procedures and requirements. PM is responsible for this training.
• External training activities – as needed and based on yearly individual development plan, chosen employees are sent to external training events organized by professional/certified educational organizations (DIA, IIR, Vienna School of Clinical Research etc.). PM training is ensured by certified external organization.
• Scientific meetings – as needed and based on individual interests and company needs