We offer our quality management consulting as a full-service engagement (Site Management and Monitoring package), but you can order its components only, which are described in more details below.
- GCP audits
Our experienced quality specialists conduct GCP audits, both on-site and in-house. Audits conducted by PharmaSich in Eastern Europe proved to be very effective since our auditors have no language barriers and have practical experience with local regulations and business practices. So they easily identify nonconformancies, precisely identify root causes and assist the auditees to implement CAPA plans.
- Vendor qualification and auditing
It is a good practice to have all local study vendors validated to ensure involvement of compliant and competent service providers. PharmaSich helps its customers to validate and to audit their local vendors including IMP depots, country level Central Labs, couriers, IMP destruction vendors, CROs etc.
- SOP writing
We develop clinical research SOPs for sites, Ethics Committees, IMP depots and clinical labs.
- Quality oversight of clinical trials
This service is actual for customers who have no operations in Eastern Europe and act through their subcontracted providers. We ensure quality control of their vendors in the course of the study. This is done by collecting feedbacks regarding vendors’ performance from investigators; co-monitoring visits with the CRAs of a managing CRO; communication with vendors and sites to identify zones of operational, regulatory, logistical, medical and administrative risks and development of comprehensive solutions to fix it.
Please, feel free to contact us on any business need that you have at your hand to get more information on the services we provide and the assistance we can offer to help you move on with your project. We want YOUR project to become OUR successfully accomplished project!