Site management and monitoring
Monitoring oncology trials can be more challenging than other therapeutic areas. Complicating factors include the severity of the disease, the recruitment of heavily pretreated patients, a high risk of mortality and co-morbidity, longer treatment regimens, multiple treatment cycles, complicated efficacy assessments, and potentially numerous (Serious) Adverse Events (SAEs). Clinical research associates (CRAs) working in oncology therefore require specific skills and expertise.
Working exclusively with dedicated and oncology experienced local CRA staff is therefore one of the hallmarks of working with our company. In line with this notion we are proud to have successfully setup and implemented our own oncology CRA-academy.
Our CRAs are fully compliant with ICH-GCP, and trained on oncology-specific monitoring and tumor evaluation criteria including RECIST 1.1, RANO, and irRC*. 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.
For the execution of oncology studies, our CRA staff liaises with our European network of specialized oncology centers and investigators.
Our oncology CRAs:
- Proactively ensure all study procedures are performed as defined by the protocol
- Train sites on “best practices” for patient recruitment and retention
- Carry out full Source Data Verification (SDV) at sites
- Identify, anticipate, and help resolve all scientific, regulatory and logistical site issues
- Assist with data query resolution and SAE reconciliation
- Track essential documents and clinical supplies
- Coordinate tasks between sites, project team, sponsor and third parties / vendors
* RECIST = Response Evaluation Criteria In Solid Tumors
RANO = Response Assessment in Neuro-Oncology
irRC = immune-related response criteria (irRC)