Data Driven Strategies for Improved Site Activation | Page 7
The submission to the EC/IRB typically occurs following the prestudy site visit. Although this can also occur prior to the pre-study
site visit, there is still a risk that the site may not be included; there
are considerable resources dedicated to the completion of regulatory
and ethical documents that require compensation. However, the
fully integrated dCRO process results in less risk that a site will not
be included because the sites are chosen based on the data-driven
forecasting process and feasibility questionnaire, thereby enabling
parallel processes.
Step 3. Contracting and budgeting processes ยป
Time savings can also be realized during the contracting and budgeting
processes with a site with which Clinipace Worldwide or the sponsor
has worked with previously, by using agreed upon standardized
language from contract and budget templates; this language can
be customized for the present protocol (Figure 5).
If EC/IRB approval is required before the contract can be approved,
the site can review and provide feedback for the contract while the
regulatory documents are with the EC/IRB. The contract can then be
agreed upon, pending EC/IRB approval, modifying a serial process
to a parallel process.
Figure 5. TEMPO enables real-time monitoring and visibility of status
Full visibility to the status and progress of these processes is available
and progress of all approvals, improving the efficiency of necessary
to Clinipace Worldwide and the sponsor through TEMPO on a 24/7
follow-ups.
basis, enabling real-time tracking of outstanding approvals and
improved efficiency with necessary follow-ups. Furthermore,
Clinipace Worldwide can also recommend vendors from a network of
the visibility of the data and progress holds Clinipace Worldwide
preferred vendors with existing master service agreements (MSAs),
accountable by demonstrating the completion of the process steps.
which reduces negotiation time and enables earlier study initiation.
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