Services

Clinical Research Services

Our Clinical Research Services are focused on the efficient, compliant and successful conduct of clinical trials within pharmaceutical companies, biotech firms, medical device organisations, Clinical Research Organisations (CROs) and research institutions.

Our services

Among other things, we provide support with:

Study start-up
Protocol development and essential documents
Feasibility and site selectie
Including a feasibility study and the selection of suitable research sites
Regulatory submissions
Including Medical Ethics Review (MREC), CTR and international submissions
Monitoring (Phases I–IV)
Including site initiation, on-site and remote monitoring, and close-out visits
Site management and site support
Optimisation of study conduct at research sites
Project management
Planning, coordination and supervision of clinical trials
Quality Assurance
Establishing a Quality Management System (SOPs), GCP compliant audits and quality controls
Supporting and advising scientific agencies
Advice and operational support in clinical research
Training & Development
We offer specialist courses for professionals in clinical research:
- Good Clinical Practice (GCP) course
  Including the Medical Research Act (WMO), ICH-GCP E6(R3) (conducting clinical trials with medicinal products) and ISO 14155 (conducting clinical trials with medical devices)
- Monitor / CRA courses
  Practical training for Clinical Research Associates
- On-the-job training and coaching
  Practical guidance for monitors and research professionals

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