Site Identification and Feasibility Assessment
The choice of sites can be a major factor in the success for failure of a study. Having the right sites involved in your study will be one of the greatest assets you have in generating the highest quality data. Selecting the sites is often and underrated process, however choosing the right site is one of the most significant factors for a successful study. Plunkett Consulting Group has developed a solid database of investigators who we have worked with and proven to be effective recruitment, treatment and evaluation of patients for clinical research.
Our process for site selection involves matching the requirements or needs of a particular study with possible sites. We look at the experience of the Investigator in the therapeutic area, evaluate their interest and motivation to work on a study and access to key resources needed.
Following our review of the study design and together with the client, we prepare a short list of possible sites for feasibility assessment. We then complete a detailed assessment of the capabilities of the site and staff to meet study requirements and gauge a realistic recruitment target. Our feasibility assessments includes areas such as:
- Investigator/Site interest
- Access to targeted patient population
- Recruitment capacity and speed of enrollment
- Confounding factors that may impact patient recruitment
- Investigator/Site experience in conducting similar trials
- Availability of qualified site personnel
- Availability of equipment/facilities required to successfully conduct the trial
- Impact of study procedures on Standard of Care
- Insurance requirements and payment procedures
- Site preference for ethics committee review process
The outcomes of our review along with our assessment of the site are provided as a customized report. We can also provide strategies to address any deficiencies recorded to allow the site to successfully participate in the study. The outcome of our feasibility assessment is a valued evaluation of the site to achieve the study outcomes.