Clinical Operations

Effective clinical planning, execution and management

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 SMARTStart clinical 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 both clinical study timelines and compliance risks, including feasibility and site selection, trial agreement and budget negotiation, and all required regulatory submissions and approvals.

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

SMARTStart is a comprehensive project launch strategy meeting covering the essential areas which drive study start-up, including:

  • Comprehensive kickoff meeting
  • 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, and patient identification and retention strategies. We align study placement with site feasibility, regulatory requirements and standard of care practices, limiting competing study impact. Additionally, we define key points of potential interest for the sites, to drive engagement and commitment to the study.

Clinical Monitoring

Clinical trials are conducted to collect clinical data to either (1) guide the further development of a product or (2) to support the approval of the product. They are not an exercise in the execution of a prescribed number of monitoring visits. Cmed processes and data systems focus on data quality, the timely collection and analysis of study databases which allow for ongoing reporting and overall delivery managed in a time and cost effective manner.

Throughout the trial conduct Cmed brings together all the strands of clinical trial execution – Regulatory, Clinical, Data Acquisition & Analytics, Medical, Pharmacovigilance and Medical Writing. Cmed Project Managers are experienced in uniting these strands and in maintaining ongoing quality control; so that the eventual QA audit of deliverables produces minimal findings, assuring confidence in the final product the study data sets, records and report.

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 clinical 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.

Monitoring Models

As clinical development continues to become more complex and expensive the Pharma industry and Health Authority regulators have responded by matching different study monitoring models/ strategies to the perceived risks for study subjects. These models can be more efficient, produce better quality data and so reduce the cost of conducting clinical trials.

The movement away from the traditional model of regular site visits can be a cause for concern to some sponsors. Cmed can help as we understand the practicalities of choosing a monitoring model for your clinical trial. The models provided by Cmed range from a completely traditional approach (for example a monitoring visit every 4 to 6 weeks) through risk based monitoring, remote monitoring of image of source and an eSource approach (whereby sites capture the clinical data live as source thus avoiding transcription of source data into an eCRF).   

Tailored to meet your needs

At Cmed, we develop our monitoring strategies by working with you to assess the many aspects of the study, the critical endpoints, the patients, the investigator sites etc. and determine and agree the optimal approach.  We also recognize that clinical trials are dynamic and will review and agree any changes with you during the course of the trial.

  • Traditional monitoring: Regular site visits performed that maximize monitor time spent at site.
  • Risk-based monitoring: A strategy adopted in advance of study initiation reflecting the subject/ site type and complexity of the study that, in some situations, can reduce monitor time spent at site.
  • Remote monitoring: A strategy that can increase site interaction allowing review of images of source data remotely (at Cmed this is facilitated by our technology), while also reducing expensive face-to-face time at site.
  • Use of sophisticated data insights which can be actioned within our technology, encapsia®.
  • eSource monitoring: Remote monitoring taken to the next level - sites capture the clinical data live as source thus avoiding transcription of source data into an eCRF. This strategy makes real-time data capture and analytics a reality.

More flexibility, more options

Cmed’s  encapsia® clinical data suite can provide you and the sites with more and better options to ensure data are captured, managed, monitored and reviewed in the most efficient possible manner.  

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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