Solutions For Study Startup
Study startup in a clinical trial is a critical stage to get your study up and running. Efficient study startup plays an important foundation for the trial’s overall success.
Progress Through Each Critical Path Step
While the definition varies across companies, study startup typically includes the process of identifying and qualifying sites, collecting essential documents at the study and site level, submitting these documents for ethics approval, and activating sites to prepare for enrollment. Successful study startup requires coordination between sites, sponsors, and contract research organizations (CROs) to achieve critical milestones in an efficient yet compliant manner.
Site Identification and Feasibility
Choosing sites with the right patient population, infrastructure, and experience is essential for a successful trial. But consolidating and evaluating various site lists and distributing site feasibility questionnaires is a time-consuming task for both study teams and research sites.
Surveying sites in a centralized manner (versus fragmented processes like emails and other portals) enables sponsors and CROs to monitor and store real-time response rates and survey results, while minimizing burden and redundant data requests of sites.
Essential Document Collection
As dictated by the International Council for Harmonization (ICH), every trial has a set of documents to collect in two consolidated areas: the electronic trial master file (eTMF) for the sponsor and the electronic investigator file (eISF) for the site. If managed manually in Excel and email, this activity requires significant time and resources while risking quality and compliance.
Working in a central solution to guide the collection and approval of documents between sites, sponsors, and CROs, and automates the flow of documents across their technology systems, will maximize time savings and improve compliance.
Budgeting and Contracting
Budget negotiation and contracting are typically the most time-consuming processes in study startup. While there will always be differences when working across individual sponsors and CROs, there is an opportunity to drive efficiency through greater consistency across study teams within an organization.
Accessing language from recently negotiated contracts, standardizing site budget templates, and commissioning a Medicare coverage analysis (MCA) to distribute to sites in the U.S. can all help streamline workflows.
Site Training
Training is an essential and well-documented activity designed to ensure research teams are qualified and adequately prepared to conduct a study. As the ICH dictates, sponsors and CROs must collect training records, curriculum vitae (CVs), and delegation of authority logs from across their teams and sites, on content both specific to the protocol and broader guidelines like good clinical practice (GCP).
Thoughtful training materials deployed within centralized technology can help increase comprehension and facilitate the necessary routing and storage of regulated training documentation. To achieve additional efficiency, invest in technology that recognizes and tracks training certificates across trials in your organization, removing redundant training requirements across research stakeholders.
Ethics Review
Ethics committees must review and approve the protocol and other documents before a site is ready to enroll participants. This includes informed consent forms (ICFs) and recruitment materials.
Partnering with a central institutional review board (IRB) in the U.S. can reduce review turnaround times, as well as ensure thorough and expert regulatory oversight. Additionally, automated submission alerts across stakeholders, and routing of documents between your central IRB and your eTMF offers the potential for additional time, labor, and quality improvement.
Research Is Complex. Make Startup Easier.
Accelerate Study Startup With Advarra Solutions
Advarra Study Startup
Guide sites and study teams with the only site-sponsor collaboration solution to give you immediate visibility and help you hit every milestone on time, including ethics review. So, you can start enrolling sooner.
Advarra Review Services
Our processes ensure efficient delivery of quality documentation, and our people provide dedicated, attentive service and expertise to support your research.
Site Enablement Services
Leverage the world’s largest study activation team by augmenting critical workflows and staffing at your research sites.
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