Clinical Operation requires expertise, accuracy, and speed as it is essential for the drug to get to market as fast as possible in order for the pharmaceutical company to receive a return on their initial investment and patients the availability of new drugs and treatments.
Our foremost goal is not low cost. We focus on performing smooth running clinical trials with high data quality that get new drugs to market for the benefit of all of us. We add years of accumulated knowledge, solid communication skills, and a good mood to every clinical trial. It is our priority and the cornerstones of CroxxMed.
We provide your team with flexibility and the services that best meet your needs.
Our highly-skilled operational teams ensure smooth planning and conduct with patient safety and data quality as our top priority regardless the therapeutic area or study phase. We keep focus on milestones and data quality and we help and guide the sites during each step of the enrollment process, so the enrollment plans are not affected by low enrollment rates.
We focus on/overview subject compliance to ensure low rates of protocol deviations, good subject visit compliance and proper handling of adverse events. Furthermore, we ensure site productivity and low query resolution rates sufficient site contact.
You can choose any standalone service or full service product depending on your needs.
Start-up period:
- Consulting authorities for scientific advice
- Protocol writig
- Study team set-up
- Feasibility assessments
- Co-operation with potential investigators
- Operational set-up; e.g. plans, guidelines and manuals vendor selection and management
- Regulatory approvals (ethics committees, regulatory authorities, biobanks etc.)
- Site contract negotiations and management
- Investigator and CRA meetings
Study period:
- Site initiation process
- Study subject recruitment planning, follow-up and reporting, contingency planning and actions
- eTMF/TMF Management and quality control processes
- Monitoring and site management
- Safety management and reporting
- Data Management
- Statistics
- Medical monitoring
Closure period:
- Close out process
- Vendor management
- Final data cleaning and database lock
- Statistical listings, tables and figures
- Study report and submissions