Data Driven Strategies for Improved Site Activation | Page 3

Step 1. Site selection »

Because the standard-of-care
may vary by country, an
international perspective is
required to understand the
country-specific treatment
settings for the target patients

The first step in the start-up process is to identify candidate sites for each study.
This requires a careful understanding of the protocol and standard-of-care for
the target patient population. Because the standard-of-care may vary by country,
an international perspective is required to understand the country-specific
treatment settings for the target patients. This process should begin during
proposal development.
Knowledge of the treatment setting is combined with data about each potential
site’s past performance regarding activation and enrollment to develop a robust
site profile. This data is incorporated into the site’s EC/IRB approval process
and timeline, contract negotiation process and timeline, and budget negotiation
and approval processes. Sites typically follow different internal processes and

procedures, and, in many cases, these are enforced through standard operating procedures (SOPs). The larger, more research-oriented sites tend to
have the most distributed and rigid procedures. However, these sites are also often highly predictable, resulting in reproducible start-up timelines
across studies.
Information regarding the site’s prior enrollment performance and data quality measures, such as protocol deviations or other issues or challenges
that have previously been identified, is also considered. This accelerates the selection of sites that provide the greatest chance of a successful trial.
These data are then used to develop a start-up timeline, plan resources, and proactively identify potential budget variances.
At the kick-off meeting for a new trial, Clinipace provides a forecasting model (explained in more detail later) that accounts for the expected
mixture of site types and incorporates the historic data, described above, that are tracked and accessible in TEMPO (Figure 2). This data is tailored
for the indication and, in the case of multinational trials, specific countries. Country-specific submission details and feedback are also stored in
TEMPO, which allow Clinipace Worldwide to proactively address the information in the submission package for each country.
To set realistic expectations for each trial, it is necessary to candidly discuss the historic site activation data from potential and target sites. This may
include comparisons between Clinipace Worldwide’s site activation data and those of the sponsors. This exercise previously revealed that, at sites
with which both Clinipace Worldwide and the sponsor had worked, the Clinipace Worldwide approach led to a consistent 7-10 day shorter timeline
for site activation.

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