Operational Expertise

Oncology Expertise – Operations

The Medelis clinical research management team is accustomed to handling most targets in oncology. We are not a training ground for people just starting in clinical research, or even oncology.  All of our operational resources are highly experienced and have proven experience in oncology studies.

• All of our clinical operations team members have at least 10 years of hands-on experience managing clinical trials, and our average length of experience is 15 years
• Our clinical operations team has managed over 425 clinical trials – and over 200 oncology studies
• Our medical monitors are physicians and former investigators with hands-on research experience in managing and evaluating safety in clinical trials
• 80% of the CRAs are nurses with oncology training (many are former oncology study coordinators)

This portfolio of expertise means faster, more accurate results and more strategic long-term development planning.

Medelis “Standards of Excellence”

Medelis’ “Standards of Excellence” criteria ensure that highly experienced clinical team members are working on your trial, to streamline the planning and start-up phase, create appropriate project plans to meet your study criteria, and quickly adapt to study challenges and changes in the regulatory environment.

Our clinical team’s comprehension of the complex issues of oncology trials translates into better problem identification, decision making and superior results. We value innovation, and our experience allows us to work smarter, to maximize cost and time efficiencies on your trial.

Project Managers

• Minimum of 8 years of clinical research experience
• Phase I/II project management experience

CRAs for Clinical Monitoring

• Minimum of 6 years of monitoring experience
• Minimum of 4 years of oncology monitoring experience
• Phase I/II study monitoring experience
• EDC experience
• Maintain high-quality relationship skills

Medical Monitors

• Medical oncologists with pharmaceutical and CRO experience
• Minimum of 12 years of clinical research experience
• Phase I/II medical monitoring experience
• DSMB experience

Efficient Trial Planning and Execution

And while in the clinic, you’ll receive the comfort knowing that our management team, project managers and CRAs all have deep oncology experience to complement their skills in operational and technical matters.

Our extensive knowledge base and expertise enables us to streamline trial planning, start-up and execution by:

• Leveraging our past trial work in phase I and phase II studies by implementing tools and processes that are proven for your trial design.
• Developing project plans appropriate to the specific needs, complexities and data density of early phase studies.
• Being flexible with sponsors’ requirements, recognizing and quickly adapting to study challenges and changes in the regulatory or competitive environment.

We value innovation and understand the importance of doing the work smarter so cost and time efficiencies can be maximized, and ensuring customer satisfaction through superior customer service and quality work.

This therapeutic depth and experience translates into faster start-up, better problem identification and resolution, more informed decision-making and a corresponding increase in the quality of your results.