11 Site Management

Barry Miskin

The investigative site serves a critical function in
the clinical development process. As the physical
location where clinical trials are conducted, its
purpose is to produce clean, reproducible clinical
data in a timely and safe manner. The site gener-
ates these data by performing the study protocol
on human subjects that it recruits. By providing
this valuable service, sites play a major role in
moving investigational products through the clin-
ical phases on their way to regulatory submission,
and ultimately, to market.
This chapter describes different kinds of inves-
tigative sites around the globe and makes the case
that operating a successful site requires an infra-
structure that enables the generation of good qual-
ity data. The infrastructure must include critical
business functions such as budgeting, patient re-
cruitment, regulatory oversight, audit preparation
and the keeping of metrics on site performance.
Investigators and clinical research coordinators
well trained in good clinical practice (GCP) are
also key to site success.

11.1 Types of investigative sites

As the clinical trials industry becomes increasingly
global, research is taking place in a variety of

venues (Figure 11.1), ranging from academic med-

ical centers to phase I units. To some degree, the

location of the study is dictated by the complexity

of the protocol, the types of procedures required

and the availability of experienced staff. But there

can be other factors at play that determine where a

clinical trial occurs.

In many locales, clinical trials take place largely

at academic medical centers, regardless of com-

plexity, using investigators who are part of a

national health service. In other regions, such as

the United States, there are many public and private

clinical trial options. Data suggest that in the

United States, approximately 35% of studies take

place at academic medical centers (Figure 11.2).

The rest occur at a combination of public and

private, dedicated and part-time investigative sites.

Thededicated sitefunctions with a staff and

infrastructure in place to enable the conduct of

clinical trials on a full-time basis. It is essentially

a business. The elements needed to operate the

dedicated site successfully are described in the

Basic Infrastructure section below.

Some dedicated sites maintain loose affiliations

with non-competing sites to share leads about

upcoming studies. Others belong to a site mana-

gement organization (SMO), which is a formal

affiliation offering centralized management,

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9