Data Driven Strategies for Improved Site Activation | Page 6

Figure 4. The completion of regulatory documents is expedited by

Particularly with sites that have an existing or previous working

electronic submission, and time savings are realized through parallel

relationship with Clinipace Worldwide or the sponsor, the pre-study

pre-study site visits for specific sites.

site visit can occur in parallel with the completion of the regulatory
documents, saving time. With these sites, the risk is minimal. The

The regulatory documents are sent via email to the sites as an e-packet,

choice to conduct these processes in parallel may also depend on the

which again reduces paper and postage costs, in addition to manual

complexity of the trial; for example, it may make more sense to do so

data entry and associated errors. Upon completion, the regulatory

with a study that involves large, more experienced sites, compared with

documents are electronically uploaded to a portal, reviewed, and

smaller sites that may have less research experience.

filed in an electronic trial master file (eTMF) in TEMPO.

clinipace.com

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