Enhanced early phase (I to IIb) clinical trial delivery

At present, greater than 40% of phase III clinical projects fail, weakening pharmaceutical company drug development pipelines and increasing development costs.  In addition, biotechnology companies have an increased desire to secure funding through stronger early phase data. 

As a direct result, for pharmaceutical companies, a greater level of focus and investment is being placed on ensuring a go / no-go decision to enter phase III is reached more efficiently and reliably, primarily through better planning and enhanced delivery of early phase (I to IIb) clinical projects, some of which are becoming more complex in design.  This shift of focus is also applicable to biotechnology companies who seek to gather more data in an early phase setting.

Cmed CS provides a unique solution to this challenge via the ability to deliver early phase (I to IIb) projects differently, faster and more cost effectively.  In addition, the architecture and capabilities of our proprietary technology, Timaeus, provides us with the ability to deliver increasingly complex projects successfully.

Cmed CS’s ability to harness the talents of our clinical teams with the benefits of our technology allows us to reduce the timelines and subsequent costs for traditional early phase (I to IIb) clinical studies.  In addition, the unique advantages of our proprietary system allow us to perform complex projects cost effectively. 

The benefits we bring include:

Study Build

Cmed CS provides its clients with greater ability to configure, build and manage their trial databases to support early phase (I to IIb) traditional and complex clinical trials.  The underlying architecture enables easy management of database configuration through each and every design change.

• Flexible database architecture
• Single point configuration
• True, integrated version control

Accessing the Best Investigators

Traditionally, selecting investigators for a clinical project can be hindered by the site’s technical capabilities, such as consistent internet connection, firewalls, etc.  Losing quality investigators for purely technical reasons means effective patient recruitment can be hampered.  These critical challenges are extinguished by Cmed CS because we are able to:

• Provide the option of using any communication medium to capture clinical trial data including dial up, GPRS, satellite, wireless LAN, or broadband
• Conduct clinical studies in any place at any time
• Set-up the site to collect and transmit trial data without interacting with site IT infrastructure

Ensure Investigator Motivation

The success of a clinical project can be attributable to ensuring investigators remain motivated throughout the duration of the trial.  Cmed CS’s unique solution addresses this challenge highly effectively through: 

• Industry leading eCRF turn speed
• Biometric logon functionality
• Absence of system shut down regardless of design changes, system updates, or maintenance schedules  
• Use of various appliances
• Absence of in-site technical hampering  

Faster project timelines

Cmed CS has proven ability to deliver clinical projects faster as a result of unique capabilities.  These include: 

• Rapid database build, weeks not months reducing study-start up timelines
• No system shut-down to alter project design or perform system maintenance thus promoting continuous patient enrolment and exceeding recruitment timelines
• Patient data is locked on an ongoing basis, reducing the need to end load, resulting in rapid database lock.

What does this mean for our clients?

Reducing clinical trial spend

Reducing the overall spend to deliver a clinical trial is vital.  Cmed CS has unique capabilities to accomplish this, primarily through:

• Delivering clinical projects faster leveraging unique benefits (as outlined above)
• Reducing data management time handling queries via real time firing of all edit checks
• Using on-demand site monitoring, not traditional schedules hence lowering CRA costs
• Capturing 100% of all third-party data in a single database thus reducing reconciliation time and lowering costs

Delivering complex clinical projects

To address the go / no-go challenge, early phase (I to IIb) clinical projects are becoming more complex.  Cmed CS has proven ability to successfully deliver such complex projects through our ability to:

• Manage 100% of all 3rd party data
• Deliver multiple cohort studies seamlessly
• Adapt protocol designs without interfering with the ongoing delivery of the project
• Provide 24 / 7 real time access to all clinical trial data thus allowing live decisions to be made from a full dataset