Novella Clinical’s Investigator Strategy & Site Coordination (ISSC) team uses a multifaceted approach to produce the most precise representation of the clinical environment for clinical research trials. Our ISSC team has the experience and relationships worldwide to support feasibility, investigator meetings, site identification, regulatory submissions, document management and complete start-up oversight. 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 to identify any challenges to the study for the purpose of quality planning and risk mitigation.
Novella’s Site Coordination team is highly experienced and dedicated exclusively to meet sponsors’ needs and study requirements for study start-up activities. Our detailed knowledge across therapeutic areas, proven processes and effective integration with both monitoring and contracts teams has consistently proven its value to sponsors in expeditious site opening.
Our team focuses on identifying and utilizing highly productive sites, efficiently achieving accrual goals and minimizing the need for new or replacement sites.
Investigator Meeting Planning
Novella offers comprehensive investigator meeting planning. In addition to ensuring an effective meeting, this allows us to build or strengthen a relationship with site staff from the beginning of the study.