Streamlining Study Startup for Clinical Research Sponsors
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, and submitting these documents for ethics approval. Successful study startup requires coordination between sites, sponsors, and contract research organizations (CROs) to achieve critical milestones in a compliant manner.
Improve Study Startup
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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.
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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 trial master file, or eTMF (for the sponsor) and the investigator file, or 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 platform that guides 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.
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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 United States can all help streamline workflows.
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Site Training
Training is an essential and well-documented activity that ensures research teams are qualified and adequately prepared to conduct a study. As dictated by the ICH, sponsors and CROs must collect training records, 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 can recognize and track training certificates across trials in your organization, removing redundant training requirements across research stakeholders.
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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 United States can reduce review turnaround times, as well as ensure thorough and expert regulatory oversight. Additionally, automated routing of documents between your central IRB and your eTMF offers the potential for additional time, labor, and quality improvement.
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Global Dashboards and Analytics
It can be difficult to track progress and milestones throughout study startup in a single study, let alone across all global studies in your portfolio. Lack of visibility into cycle times and overdue activities can inhibit your ability to mitigate delays and compliance risks.
Centralized and unified reporting enables your team to identify roadblocks and take any necessary actions to keep your study moving forward. Key metrics to monitor include feasibility status, training compliance and completion rates across your sites, document collection status, and IRB review status.
Accelerate Study Startup with Advarra
Our comprehensive study startup solutions empower clinical research teams with efficient workflows, expert teams and services, and integrated technology to help you accelerate critical milestones and improve operational outcomes.
training compliance
achieved during initiation of large Phase III vaccine trial
faster
activating central IRB sites vs. sites relying on local IRBs
hours saved per month
automating flow of Advarra IRB documents into sponsor’s electronic trial master file (eTMF)
Study Startup Solutions and Services
Related Resources
What Sponsors Need to Know About Medicare Coverage Analysis
Discover the role of MCA in clinical research, its impact on study activation timelines, and how outsourcing can streamline trials.
4 Modernized Functions Every Sponsor Needs for Study Startup
This white paper outlines four technology capabilities sponsors need to expedite the study startup process.
Expedite Study Startup: Four Strategies to Optimize Site Activation
Learn how organizations can expedite study startup by streamlining site selection, training, ethics review, and site initiation.
