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Quality management, training and development

Home  /  Quality management, training and development

Quality management, training and development

MERC's Quality Team is assisted by Sr. Nadia van Den Heever We have a Dedicated Quality team comprising Quality Defenders (QD's) and Operation Compliance Designees (OCD's)

Quality Assurance

  • Internal audits – Focused on inspection readiness – RED FILE
  • Study vendor and site level audits

Operational Compliance

  • Operational Compliance visits performed regularly by Quality Defenders.
  • Review of monitoring reports to assess trends – FU Letter Training Sessions
  • Management of Quality Issues (QIs) (root cause analysis, CAPA process) Supporting client audits/reg inspections

SOP Management and Mandatory Training Licenses Management

  • 75 SOPs issued to date and controlled Docs (Standardisation of processes)
  • Training-file Management (Centralized GCP, IATA & Anti Bribery training)
  • Mandatory training licenses are issued for GCP, IATA, and Anti Bribery courses (completion ensured within required timescales)

Experienced teams and dedicated Data Coordinators who work full time on data entry

  • DCs are trained and experienced in all commonly used eCRF and safety reporting systems
  • Timely data entry and rapid query resolution – metrics to monitor data entry
  • Close management of database locks – enables timely sponsor data analysis

MERC places high emphasis on quality from its PIs and sites 

  • Quality management system with adherence to Standard Operating Procedures, implementation and updates
  • Effective induction, training and supervision of study staff .Visit worksheets clear and consistent. AE and SAE reporting and monitoring .
  • Site files maintenance and GCP compliance regularly reviewed
  • Adherence to ethics and patient confidentiality
  • Continual quality reviews and internal audit across sites
  • Weekly meetings for quality team and doctors
  • Core study team approach for every study
  • CMO leadership and hands on approach
  • Partnership governance plan also covers quality oversight