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.
|Investigational Site Identification
|> 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 documentsTrack IRB
|Informed Consent Form Language||> Manage the negotiation of the site-specific
informed consent language.
> Obtain the sponsor’s final approval for modified
> 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
|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
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.