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“Standards of Excellence”

MedTrial ’ “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.

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MedTrial “Standards of Excellence”

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.

Oncology Expertise – Operations

The Medtrial Solution 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 25 clinical trials – and over 20 oncology studies

· Our CRCS and investigators with hands-on research experience in managing and evaluating safety in clinical trials

· 80% of the are nurses and Phlebotomist with oncology training

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

Efficient Trial Planning and Execution

You’ll receive the comfort knowing that our management team, managers ,and CRCs 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.

Oncology Expertise – Site Training

Medtrial Solution has been managing checkpoint inhibitors and Phase ans BA/BE STUDIES since 2015 – so we’ve been able to work with many sites in the India to develop the safety SOPs and train them.

Proper site is the success of any oncology study. It’s even more critical in the rapidly expanding area of cancer immunotherapy.

To get the right data within your timelines, you need:

· The investigators who have access to the patients your study requires

· The right mix of sites (academic, government and community-based) that are able to get patients enrolled within your timeline

· Sites that are skilled and experienced in handling the type of treatment being administered

· Sites that understand how to deal with the differences in how the immune system reacts to these types of treatments

These variables directly affect your study cost and data quality. In addition, if your study is phase I, you will also have to evaluate their dose-escalation experience (and we address that here).

Communication with the nurses is an ongoing process, not a one-and-done process .We meet with the site before the initial infusions to coach them through the side effects. We hold continuing team meetings with site physicians and coordinators, so we can debrief and help to anticipate what may happen with other patients. From our experience, this constant communication process does improve safety.

For every study, we:

· Record the audio of the meetings

· Maintain a list of FAQ that we send back to sites

· Take detailed minutes

· Save meeting recordings and share with the team

· Share everyone’s cell phone numbers to enable real-time communication

· Communicate one-on-one with each nurse

This last point isn’t common in all studies, but it’s important, because at times coordinators aren’t that forthcoming in group calls / phone meetings due to a fear of not wanting to sound “dumb” in front of their colleagues. It’s human nature. One-on-one communication allows them to ask the important questions.