Selecting the appropriate investigators and sites is important to the success of any clinical trial, and is a multi-stage process. With over 35 years of experience, Datapharm has worked with many trial sites in Australia, New Zealand and other countries in Asia, Americas, Middle East and Europe and can assess the qualifications, experience and resources of these sites and investigators.

Site feasibility initially involves a broad assessment of trial site candidates, and is a critical component to a successful trial. Datapharm has access to a large number of sites across all therapeutic areas, and we will work closely with you to ensure the most suitable investigators and sites are chosen for your trial. Multiple factors come into play when identifying a site for a clinical trial.

These include advice from known Key Opinion Leaders (KOLs), Investigators, the Sponsor’s previous experience, literature searches, registry searches, and medical specialist associations. Geographic location of suitable participants should match trial sites, as travelling to a site can impact recruitment. Additionally, time-critical trial logistics, including product delivery, sample shipping to labs, and access to patient populations can also be a factor.

The next step of this process is trial site selection, which occurs once a shortlist of trial sites  have been identified that are best-suited for your clinical trial. From the outset, we aim to develop a strong relationship with trial sites and pre-study, or site qualification visits, are often a component of the site selection process. Our monitors will liaise with sites to ensure they meet your trial's requirements.

Ensure that your trial begins with the right trial sites, and the right CRO.

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5 Takeaways: Clinical Trial Site Feasibility & Selection

  1. During the feasibility stage, it is important to gain a better understanding about a site's access to the study population. Providing more information about the study will result in a more accurate assessment and can be used to identify potential issues with study design.
  2. For all phases of clinical trials, it is important to assess the investigator’s previous experience with similar studies. However, sites that show high levels of interest and a commitment are also highly desirable as a ‘make-it-happen’ attitude is necessary in approaching new clinical research projects.
  3. Access to adequate resources to run a trial is fundamental, for example, sufficient site personnel, equipment and facilities on-site. Identifying any gaps and working towards building a successful project team.
  4. It is important for the Sponsor to be aware of any potentially competing studies within the same trial site.
  5. While budget discussions with potential sites can be the determining factor in selecting a site, our team has experience in preparation of draft budgets that are transparent to support clarity of budget planning discussions with sites and Sponsors.


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