Clinical Monitoring

Overview

Cmed knows clinical trials. We understand that clinical studies for your product make up the most expensive, labor-intensive and time-consuming component of your development process. And the clinical development landscape just keeps getting more complex:

  • Expanding geographical spread of sites.
  • More complicated clinical study protocols.
  • Increased regulatory agency expectations.
  • Stringent post-marketing commitments.
  • Continuing adoption and adaption of industry standards and best practices.

One sure constant is that time is of the essence. Getting your trial complete on time is critical to realizing your investment – and more importantly, to helping patients that need your treatments.

How we ensure excellence in delivery

  • We focus on excellence in delivery while maintaining the integrity of your data.
  • Our transparent approach combines tried and true methods of program management, study start-up and clinical monitoring.
  • We build strong partnerships based on open, honest communication and on teamwork to deliver successful outcomes.
  • We work in tandem with each study site to ensure that patient safety and standard of care practices are the first priority.

Our people are our success

Cmed’s highly experienced clinical project managers lead teams built based on the needs of your project – so you’ll have the right skills at the right time. And the staff assigned to your trial is dedicated to you throughout the life of your study! This is how Cmed is able to design and deliver on your program in this increasingly challenging space.

Feasibility & Study Start-Up

Rapid start-up facilitates rapid study completion – which is critical when time means money. Cmed understands. Our study start-up process is collaborative, drawing on our team’s cross-functional expertise. From start to finish, we track and report start-up metrics to manage clinical study timeline and manage compliance risks including agreement negotiation timelines, budgets and all required submissions and approvals.

Services include

Investigational Site Identification and Qualification
  • Identify and qualify the investigational sites, in cooperation with the sponsor.
Ministry of Health and Investigational Review Board / Ethics Committees Applications
  • Provide full development and submission of required country- and site-level applications required for clinical trial approval – including detailed requirements by country and documents needed in the Study Start-up Plan.
  • Collect and track regulatory documents.
  • Complete IRB application.
  • Submit required IRB documents.
  • Track IRB approval status.
Informed Consent Form Language
  • Manage the negotiation of the site-specific informed consent language.
  • Obtain the sponsor’s final approval for modified informed consent.
  • Perform a final quality check to assure IRB’s final approved documents include sponsor’s requirements and meets required regulations.
Site Budget Development and Negotiation
  • Develop site budget with the sponsor in accordance with principles of fair market value, for both data collection and medical procedures in accordance with the protocol.
  • Negotiate the budget within pre-approved parameters.
Clinical Trial Agreement Template
  • Manage the drafting, distribution and negotiation of the clinical trial agreement using either the sponsor’s or Cmed’s template.
  • Negotiate the agreements within pre-approved legal terms

Accelerate your study start-up with Cmed’s SMARTStart Process

The “Cmed SMARTStart Process” is a comprehensive project launch strategy meeting which covers the essential areas which drive study start-up, including:

  • Comprehensive kickoff meeting strategy
  • Country feasibility
  • Site selection
  • Submission planning
  • Expedited site contract methodology

This process sets the stage for more efficient site initiation/activation and recruitment success. Cmed provides a dedicated team of professionals who work seamlessly with their customer counterparts to accelerate the study start-up process.

Cmed’s SMARTStart Process helps you succeed

  • Our cross-functional team collaborates with you upfront, to agree upon a cohesive strategy and mutually clarify expectations.
  • We create your study execution framework upfront, helping to jump start plan development, robust risk planning, patient identification and retention strategies.
  • We align study placement with regulatory requirements and standard of care practices, limiting impact of competitive study impact.
  • We define key points of potential interest for the sites, to drive engagement and commitment to the trial.

Clinical Monitoring

Clinical Research Associates (CRAs) are the foundation for successful delivery of your trial. Cmed’s seasoned CRAs are dedicated to the integrity of your study data and patient safety, ensuring quality through both onsite and remote monitoring. Site investigators and teams consistently tells us that they value the partnerships our CRAs establish and the demonstrated level of skill and commitment brought to their sites.

Our CRAs:

  • Have the experience and skills to deliver trials within a wide range of therapeutic areas, including indications that are rare and highly complex to treat.
  • Understand the standards of care associated with each trial and importance of patient safety; site management is a holistic approach to ensuring regulatory and study compliance is maintained.
  • Have a turnover rate well below industry average, a testament to both the culture at Cmed and the great working relationship they have with our sites and customers.

Project Management

Having the right Project Manager (PM) in the right place is critical for your trial’s success. Rely on Cmed’s Global Clinical Project Management team to be there when you need them. We offer services from both Europe and North America. Our PMs work effectively and diligently to ensure delivery that’s on time, on budget and of the highest quality.

The Cmed difference

Diligant Planning Thoughtful and thorough planning is the foundation of the success of any project. Prior to implementation of the project, our team prepares your comprehensive project plan outlining the project scope, detailed timelines, project milestones and potential issues which may arise throughout the project.
Clear communication Clear and timely communication with study team members, clients, sites and vendors is one of the most important aspects of efficient clinical trial management. We will:
  • Define the communication plan with a central point-of-contact for clients
  • Have regular meetings with the project team
  • And provide frequent status reports on the progress of the project.
Proper execution Effective and efficient project management tools and our seasoned management experience allows our project managers to oversee the performance of the project team, control the critical components and ensure timely execution of project deliverables.
Proactive solutions Our risk management strategy outlines contingency plans in advance and triggers for risks. Our project teams thrive on unique solutions to improve the efficiency, quality and timeliness of your project.
Responsiveness Our project managers pride themselves on meeting and exceeding your needs and expectations. We deliver rapid and detailed responses to your requests and ensure your expectations are understood by the project team.

From study start-up to close-out, our PMs carefully monitor and track the progress of your study using industry leading reporting tools, such as IMPACT® CTMS. You know what we know, using our in-house trial dashboard to check the status of your trial and view your data. Transparency and openness in communication is critical to the way Cmed operates.

Want to learn more?

Please feel free to contact us if you would like to learn more about our skills and experience. We are friendly, open and here to help.

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