• Effective clinical
    planning, execution
    and management

  • Study Start-Up

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 documentsTrack 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.