Clinical Monitoring

Clinical Monitoring

Our clinical monitoring services are conducted by qualified Clinical Research Associates (CRAs) who have attained either an MD or life science degree. They are locally based, fluent in the local language and English with an in-depth knowledge of the local regional health care system and leading country investigators. All monitoring services are conducted according to ICH-GCP principles, SOPs and local regulatory requirements, ensuring that the safety of study subjects is not compromised and the data is of the highest quality and integrity.

Our CRAs go through an extensive training scheme and are familiar with the latest e-clinical technologies such as CTMS, EDC, EPRO, eTMF, IXRS. as an institution, we emphasise the importance of professional relationships with study site personnel and the need for a detailed approach to complex and careful source data verification.  

Our CRAs are managed by our experienced PDs, who review monitoring reports and daily activities and ensure our high standards are consistently reached and maintained throughout the duration of the study.

We train our CRAs to be:

  • flexible
  • communicative
  • have organisational skills
  • prioritize
  • work in a team; and
  • have excellent attention to detail

Accord Research’s main CRA capabilities are:

  •  Study Feasibility execution
  • Management of Site selection, initiation, monitoring and closing clinical sites
  • Essential document collection from clinical sites
  • Regulatory document review
  • Ethics Committee and Competent Authority submission
  • Site contracting process support
  • Management of recruitment process
  • Site management and communication with sites resolving site-related queries and escalating issues as necessary
  • Drug Accountability
  • Preparation of documents for administration of investigator’s payments
  • Ensuring adherence to ICH-GCP principles