Qualification of centres of excellence for clinical research
Clinical Research has contributed over time to the development and optimisation of healthcare in many therapeutic areas. Despite major advances in terms of infrastructure and human resources, there is a need to enable healthcare facilities to establish clinical research centres of excellence in key markets. Therefore, a centre qualification solution involves a combination of consultancy and training services, designed for the specific needs of each institution.
Management and organisation of the centre
- Creation of SOPs;
- Organisation of the centre’s documentation;
- Team organisation;
- Definition of management and performance indicators;
- Presentation of results for the collection of clinical trials and non-interventional studies for your institution.
Quality and safety
- Preparation for audits and inspections;
- Recognition of centre’s responsibility for the clinical trial or non-interventional study pharmacovigilance.
Development of the centre’s competencies
- Methodology in Clinical Research: essential skills;
- Good clinical practice;
- Ethical and National Law: clinical trial guidelines;
- Regulatory submission process: knowledge of the process.
Development of professional skills
- The role of the pharmacist in a clinical trial: technical-essential knowledge;
- Coordinator of clinical trials: recognition of the different types of clinical trials;
- Clinical trial investigator: identification of your responsibilities according to the different types of clinical trials.
Periodic evaluations and measurement of results
- ISO 9001:2015
Quality Management Systems
- NP 4457: 2007
Research, Development and Innovation Management Systems
- NP ISO 56002
Innovation management systems. Guidelines”, resulting from the international standard: “ISO 56002:2019 Innovation management – Innovation management system – Guidance”.
- HR Excellence in Research:
“Ensuring Excellent Research by Investing in Researchers’ Talents, Skills & Career Development – Implementing the Human Resources Strategy (HRS4R)”,
selo atribuído pela Comissão Europeia. HRS4R | EURAXESS (europa.eu)