Services

Tailored clinical trial operations management

Expert oversight of CROs and teams, with additional support in the stage you need.

• Oversight of CRO and CRA performance

• Site oversight and engagement

• Monitoring of risks and issues throughout the study

• Additional support for your team during start-up, peak workload periods, or close-out

• Flexible, ad hoc support with no long-term commitment

Monitoring and site management

Planning and coordination of your study from start-up through close-out, providing support wherever you need it.

• Feasibility and site selection

• Protocol review and preparation of informed consent forms and patient-facing documents

• Preparation of study plans, including monitoring plans and other customized documentation

• Preparation and submission of documentation to competent authorities and ethics committees

• Contract negotiation with study sites

• CRA coordination

• Site activation

• Monitoring

• Management and tracking of timelines, risks, and vendors

• Team and sponsor meetings

• Study close-out

Monitoring tailored to your project, with data quality, protocol compliance and patient safety as our top priority.

• Initiation, monitoring and close-out visits

• Data verification and quality

• Site coordination and management

• Audit and inspection readiness

• Regulatory updates during the study

Expert oversight and flexible clinical support