Study Start-Up at Novella Clinical is coordinated by Novella’s Integrated Site Services (ISS) team. We use a multifaceted approach to produce the most precise representation of the clinical environment for clinical research trials. Our integrated team has the experience and relationships worldwide to support site feasibility, site identification, regulatory submissions, document review, site management through start-up, site contracting, and complete start-up oversight.

Feasibility

Utilizing a flexible model, we can perform different degrees of feasibility based on the unique needs of the sponsor.

Supplemental Sites: If a study is active, and the sponsor requires additional sites for rapid study expansion, we can quickly survey new sites for participation and qualification.

Comprehensive Feasibility: Alternatively, if the sponsor requires a detailed view of the clinical environment before initiating a trial, a comprehensive feasibility can be conducted to include Novella-derived information on the clinical space, supplemented with site-level surveying to refine and validate the higher level intelligence gathered.

High-Level Feasibility: When the sponsor is confident in its knowledge of the clinical environment before initiating a trial, we routinely conduct a high-level feasibility assessment to identify any challenges to the study for the purpose of quality planning and risk mitigation.

Our team focuses on identifying and utilizing highly productive sites, efficiently achieving accrual goals and minimizing the need for new or replacement sites.

 

Study Start-Up

 

Investigator Meeting Planning

Novella offers comprehensive investigator meeting planning. In addition to helping ensure an effective meeting, this allows us to build or strengthen a relationship with site staff from the beginning of the study.

Study Start-up