Sano blog

Clinical trial recruitment: 7 ways to de-risk studies with Sano

Written by Sano Marketing Team | Aug 24, 2023 4:14:19 PM

Precision medicine trials introduce requirements that most traditional recruitment and enrollment workflows are not designed to handle. Genetic eligibility, biomarker testing, longitudinal engagement, and multi-country coordination each add complexity, and when managed through disconnected vendors and processes, they create delays and operational risk. Sano works with sponsors and researchers to address these challenges across the trial lifecycle. Below are seven practical ways teams have worked with us to design, execute, and deliver precision medicine programs more effectively.

Key Takeaways

  • Precision Study Design: Utilize trial-enabling protocols to double recruitment rates compared to industry benchmarks.
  • Multichannel Recruitment: Access participants via genetic databases, EMR analysis, and patient advocacy partnerships.
  • Digital Efficiency: Streamline operations with HIPAA-compliant digital consent and up to seven years of EMR retrieval.
  • Biomarker Integration: Implement end-to-end DNA testing and genetic counseling to increase drug trial success rates.
  • Enhanced Retention: Reduce dropout rates (which can reach 40%) using a Virtual Waiting Room and customized engagement plans.

1. Study planning

Many recruitment challenges originate not in outreach or site performance, but in the protocol itself. Overly restrictive eligibility criteria, excessive endpoints, and workflows that do not account for the patient experience can constrain enrollment before recruitment even begins. For precision medicine trials, this is compounded by the need to integrate genetic testing, biomarker confirmation, and multi-step screening into the study design from the outset. Sano works with sponsors early in the planning process to draft, refine, or optimize study designs that balance scientific rigor with practical enrollment considerations. This means aligning eligibility criteria with real-world patient populations, designing workflows that reduce participant burden, and integrating the patient perspective from the start.

Our work often begins with the development of a trial-enabling protocol. This document defines how patients will be identified, how screening and testing workflows will operate, and what the key engagement touchpoints will be across the participant journey. By addressing these questions before recruitment begins, sponsors reduce the risk of mid-study course corrections and the cost associated with redesigning workflows under enrollment pressure.

A recent Parkinson’s project allowed Sano to demonstrate the importance of this type of protocol. An innovative biotech company approached Sano to identify and screen Parkinson's disease patients with LRRK2:G2019S mutation in the USA and Europe. We created and executed a trial-enabling protocol and identified eligible patients at a rate 2x the industry benchmark. 

2. Patient recruitment and prescreening

Finding the right participants is one of the most persistent challenges in clinical research. Most eligible patients are unaware that relevant trials exist, and site-based referral alone rarely generates sufficient volume, particularly for rare disease or genetically defined populations. Sano addresses this through a coordinated, multi-channel recruitment model that includes genetic databases, digital medical record analysis, patient organization partnerships, digital advertising, healthcare provider outreach, and more. Each channel is tracked and optimized in real time, giving sponsors visibility into where patients are coming from and where conversion is strongest.

Once patients express interest, Sano prescreens them through a structured digital workflow. In collaboration with sponsors, the team designs a prescreener that balances clinical specificity with simplicity for the participant. Integrated directly into the Sano Platform, this step filters out ineligible patients early, reducing the burden on sites and ensuring that only qualified candidates progress to the next stage of the enrollment process.

For example, for a study aiming to identify a genetic link to COVID-19, Sano helped recruit participants who had a previous genetic test. Sano was able to enroll 484 qualified participants in 80 days, allowing recruitment to close three months sooner than expected.

3. Digital consent and EMR retrieval

In precision medicine trials, eligibility often depends on clinical history, prior test results, or biomarker data that patients may not readily recall or report accurately. Digital consent and electronic medical record (EMR) retrieval address this by creating a more complete and verifiable picture of each participant early in the process. Sano's digital consent workflow guides participants through a clear, compliant process that meets data privacy standards while reducing friction and drop-off at the consent stage. On the EMR side, Sano provides HIPAA-compliant record retrieval and abstraction, giving sponsors access to up to seven years of medical history, including labs, scans, clinical notes, and more. This enriches patient profiles, maps healthcare journeys, and strengthens the identification of research-eligible patients before they reach a site.

4. Biomarker testing

Trials testing drug targets determined through genetic evidence are twice as likely to be successful. That’s why a core Sano offering is biomarker testing – we’ve provided this service to trial sponsors, populations genomics organisations, and patient advocacy groups. 

Precision medicine researchers come to Sano for guidance in confidently planning and implementing DNA testing strategies. Our team of experts, well-versed in medical research, genetics, and secure software engineering, partners with sponsors to define their particular study's genetics approach.

Sano manages the end-to-end biomarker testing process, including:

  • Feasibility & Planning: Assessing costs, regulations, and protocols.
  • Screening: Conducting genetic testing for target variants.
  • Result Delivery: Returning data and providing genetic counseling as required.

Here’s how this looks in practice: For an Alpha-1 antitrypsin deficiency (AATD) study, a sponsor and their CRO came to Sano to identify participants with a rare genetic variant (present in one out of 3,000 Europeans) who met additional complex medical criteria as well. We provided genetic testing to screen patients, reaching 90% of our genetically prescreened referral target in month one.

5. Patient engagement

The challenge of participant dropout remains a significant hurdle in clinical research, with dropout rates reaching up to 40%. In precision medicine and rare disease trials, the impact is amplified: each patient who drops out is harder to replace, and the cost of re-recruitment from an already constrained population can be substantial. Common contributors to dropout, such as lack of communication, feeling undervalued, or uncertainty about what comes next, are addressable when engagement is designed into the study from the start. Each participant engagement plan Sano delivers is customized to the specific trial, sponsor needs, and population being engaged.

A core component of this approach is Sano's Virtual Waiting Room. It provides a structured environment where participants receive updates, educational content, reminders, and support between study milestones. This keeps patients informed and connected throughout the research process, particularly during periods where there may be no active study visits, reducing the communication gaps that commonly lead to disengagement.

6. Long-term engagement and recontact

In most trial models, the relationship with a participant ends when the study does. Screening data, consent records, and contact information are archived, and any future program requires starting recruitment from scratch. For precision medicine sponsors running multiple studies within the same therapeutic area or patient population, this represents a significant structural inefficiency.

Sano enables sponsors to maintain compliant, ongoing relationships with participants beyond a single study. Through tailored communications, return-of-results pathways, pulse surveys, and recontact workflows, participants remain informed and engaged between programs. When a new study opens or follow-up is needed, sponsors can re-identify and reach eligible patients from an existing, consented population rather than rebuilding the funnel.

This approach is particularly valuable in rare disease, where patient populations are small and every consented participant represents a meaningful part of the available cohort. It also supports sponsors running sequential trials, such as natural history studies followed by interventional programs, where continuity with the same participants improves both data quality and enrollment predictability.

7. Unified research portal

When recruitment, biomarker testing, consent, engagement, and analytics are managed through separate systems and vendors, sponsors lose visibility, introduce handoff risk, and spend significant effort on coordination. Sano's unified platform consolidates these workflows into a single, configurable research hub that supports the full participant journey, from first contact through long-term follow-up. For pharma and biotech companies, population genomics organizations, and patient advocacy groups, this means consistent data, integrated workflows, and a single view of participant status across every stage. Sponsors can choose a self-serve configuration, retaining direct control over data and participant interactions, or opt for fully managed services where Sano's team handles day-to-day operations. Both models are supported by the same underlying platform and compliance framework.

Each of these entry points addresses a different stage of the precision medicine trial lifecycle, but they share a common design principle: reducing the operational fragmentation that slows enrollment, increases cost, and limits what sponsors can learn from each program. Whether a team needs support with a single workflow or is ready to consolidate the full participant journey onto one platform, Sano provides the infrastructure and expertise to execute with greater visibility and control. If you'd like to discuss which approach fits your program, please get in touch below.

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