Due to complicating factors like the diversity and severity of the disease, the recruitment of heavily pre-treated patients, a high risk of mortality and co-morbidity, complicated efficacy assessments, and potentially numerous serious Adverse Events (SAE), monitoring of oncology trials can be more challenging than other therapeutic areas. Clinical research associates (CRAs) working in oncology therefore require specific skills, expertise and continuous training.
Working with dedicated and oncology experienced CRAs is therefore one of the characteristics of working with ODC. We are proud to have successfully setup and implemented our own oncology training model which includes training and workshops with the relevant key opinion leaders of the relevant indications, guidelines, ICH-GCP, ethical aspects and drug law.
Our CRAs are fully compliant with ICH-GCP and trained on oncology-specific monitoring and tumour evaluation criteria including. Beyond therapeutic and operational expertise, they have built strong relationships with the oncologists and study teams at various sites over the years. Our CRAs maintain close and frequent contact with each site to be up-to-date with the site activities and to proactively address any questions or concerns.
Our trials are conducted in over 250 sites throughout Europe. We often work with internationally recognized centers of clinical excellence in Europe, North-America and Asia Pacific.
Our clinical monitoring services include:
- Site identification/feasibility
- Site qualification visits
- Site initiation visits
- Site monitoring visits
- Review of informed consent process
- Review of site SOPs, policies and procedures documentation
- Ongoing monitoring of site/study recruitment
- Source data verification (SDV) according to Monitoring Plan
- Assistance with data query resolution
- Safety reporting (AE and SAE reporting procedures) and SAE reconciliation
- IMP review, accountability and return/destruction
- Investigator site file review and reconciliation
- Site audit/Inspection preparation and assistance
- Site close-out visits
- Training of sites on “best practices” for patient recruitment and retention
- Identify, anticipate, and help resolving all scientific, regulatory and logistical site issues
- Tracking essential documents and clinical supplies
- Coordinate tasks between sites, project team, sponsor and third parties / vendors