Overcoming the Barriers and Risks Related to N of 1 Trials

There has been a sharp increase in the demand for n of 1 trials. Many institutions are vying to become the dominant leader in this space because of the numerous benefits. However, significant challenges are preventing scaling these trial types, primarily regulatory compliance. Leading research institutions rely on Complion eRegulatory to help overcome these barriers.


The increase in precision and personalized medicine has accelerated the demand for n of 1 trials as a treatment option, and in response to decreasing patient enrollments in sub-segmented disease areas.

Many institutions are vying to be the dominant player in this n of 1 category due to several benefits, including:

  • Providing life-saving and/or improving treatment to sick patients, often left without any other options
  • Requirement and/or differentiator to secure institutional accreditation and/or grant funding
  • Enrollment of every patient possible in orphan and small sub-segmented patient populations to inform and improve care
  • As part of a proven strategy to attract and retain patients and top investigators by accommodating for the clinical trials they need

However, there are significant challenges to scaling the number of trials needed to reach the many and growing sub-segmented disease areas and patient populations required for n of 1 trials. Leading research institutions consistently list regulatory compliance as a primary barrier to meeting the demand for n of 1 trials.

Why? Simply put, n of 1 trials have more stringent requirements which often lead to greater risk. Some of the reasons include:

  • Higher investigator and/or institution compliance risk due to the increased requirements of being the study sponsor (e.g. investigator-sponsored IRB or IND/IDE studies)
  • More heightened scrutiny from FDA and other entities due to higher risk designations for cutting-edge, novel and experimental treatments, often resulting in in-depth annual evaluations
  • Increased regulatory protocol complexity to initiate and support larger, diverse clinical teams with multiple cohorts having frequent amendments and safety events

Additionally, there are significant cost and staffing challenges as research institutions have to perform double the work with the same resources, staff, and budget with much fewer patient enrollments. Compared to many other types of trials, n of 1 trials have fewer patient enrollments with less budget.

Even the most well-funded research institutions are bottlenecked due to staffing shortages for highly experienced coordinators and regulatory specialists with experience in these complex regulatory types of trials and disease areas.


Many leading and aspiring research institutions have successfully and dramatically scaled their research portfolio of n of 1 trials new study starts with existing staff and budget using Complion.

Complion is the industry-leading investigator regulatory solution for clinical trial sites. By focusing on automating investigator regulatory compliance, Complion enables accelerated study startup and on-demand monitoring, allowing sites to start backlogged trials. Complion’s unique compliance-automated platform helps remotely manage all stakeholders and documentation throughout the clinical trial life-cycle and research portfolio.

Specific benefits include:

  • Up to 5x faster audit-readiness for annual evaluations and inspections
  • 75% decrease in monitoring interactions with sites
  • Up to 3-month acceleration of study startup to get patients on the studies they need without losing them to follow up, significant disease progression or death
  • 20% productivity boost for sites and project teams

In close collaboration with leading institutions, Complion has established best practices available for n of 1 trials, as well as specific study templates to accommodate for unique and complex regulatory requirements. These include, but are not limited to: COG (Children Oncology Group Studies), Single Patient IND/IDE, HUD (Humanitarian Use Device), NCTN (NCI National Clinical Trial Network), Orphan/Rare Disease, Master Trials (e.g. bucket, umbrella, etc), PK (Pharmacokinetics), Sample Trials.

Research institutions can quickly leverage these out-of-the-box templates, and years of knowledge through expert consultation from Complion’s Customer Experience team who partner with institutions from day one to provide a personalized onboarding experience, training, and support.

Leading research institutions choose Complion eRegulatory based on its unique ability to deliver solutions that help scale their research portfolio:

  • Immediate creation of regulatory and source files with up to 60% of relevant shared documents filed automatically with ISF Connect to IRBs. These on-demand and up-to-date documents include: equipment / facility approvals, patient source documents (across multiple n of 1 trials if-needed), staff credentials, entity and protocol- level documentation
  • Study team management for credentialing, training, and delegation of large study teams across multiple departments with Training Hub and DOA
  • Reducing patient safety risks by providing study teams with mobile portal to correct and maintain up-to-date patient and study information (results, adverse events, treatment roadmaps) across studies
  • Up to 5x faster filing and loading of documents that are easy to use for new study team members and supporting teams (e.g. pharmacy, labs, etc)
  • On-demand and self-service remote monitoring, including remote Source Data Review / Verification, that eliminates 75% or more of study team and monitor interactions

Complion’s unique compliance-automated platform enables real-time regulatory compliance and risk-reduction in study startup, monitoring, audit, inspections, and closeout. The technology is built with regulatory best practices and standards, integrations, and validation materials, and can be live in as little as 4 weeks.

Whether on-site or remote, Complion eRegulatory solutions eliminate paper, redundancies, manual processes, and site monitoring burden. Through a combination of automated eRegulatory workflows and comprehensive support, we help you start more studies with more investigators faster.

Ready to learn more?   Simply schedule your personalized demonstration, or contact us to get started!