Accountable Research Organization

Engineered to give you confidence and control over your neurology clinical study

Neurology trials are won and lost on finding the right patients and keeping them.

Diagnostic instability, washout requirements that risk patients' functional independence, and visit schedules that actively trigger the conditions being studied create a system where enrollment projections collapse after activation and retention degrades in the patients most important to retain.

Lindus integrates EHR-based identification across fragmented care pathways, decentralized delivery that removes exertion as a dropout trigger, and concierge support through washout into a single operating model built for CNS trial complexity.

Challenges and strategies in neurology trials

Enrollment success is engineered, not left to chance

Insomnia ME/CFS Long COVID Myasthenia gravis Cluster headaches Narcolepsy type 1

Obesity

Challenge

Lindus approach

Dual-gate diary and polysomnography screen failures

Challenge

Multi-week subjective diary compliance is required followed by objective polysomnography validation. Patients with cognitive fog miss diary entries or fail thresholds, while discrepancies between perceived distress and objective sleep architecture cause PSG failures for patients who cleared the diary gate. Coordinating sleep lab infrastructure alongside diary monitoring inflates per-patient acquisition costs.

Lindus approach

Lindus pre-screens candidates using documented EHR sleep study results and prescribing histories before the diary run-in opens. Citrus ePRO/eCOA deploys cognitive-fog-timed automated diary reminders, and patient concierge coordinates overnight polysomnography logistics: managing transport and scheduling to compress the identification-to-qualifying-visit gap.

Medication washout and rebound hyperarousal

Challenge

Patients rely on established sedative regimens, and washout triggers rebound insomnia and acute hyperarousal that patients refuse to risk. Consent refusal rates are structurally elevated, and enrolled patients covertly resume background medications: introducing protocol deviations and confounding sleep architecture endpoints. The cohort drifts toward mild medication-naive presentations.

Lindus approach

Lindus stress-tests washout duration against real-world sedative prescribing from 40M+ EHR records before finalization. AI-assisted screening pre-qualifies candidates whose medication histories suggest washout compatibility. Patient concierge coordinators maintain dedicated contact through the washout period to reduce covert non-compliance and dropout when symptomatic patients are left unsupported.

Daily eDiary cognitive burden

Challenge

Daily morning diary completion is most cognitively demanding for patients whose chronic insomnia produces the fatigue and mental fog that impede consistent tracking. Missed entries generate screening failures when thresholds are not met, and inconsistent reporting creates statistical noise that increases over-enrollment requirements and extends recruitment timelines.

Lindus approach

Citrus ePRO/eCOA deploys low-friction automated reminders tuned to sleep endpoints and calibrated to periods of least cognitive impairment. Centralized real-time monitoring flags missed diary entries within hours so patient concierge coordinators intervene before disengagement compounds. Embedded biostatistics models missing-data thresholds to right-size your sample without reactive over-enrollment.

Protocol burden triggering post-exertional malaise

Challenge

Standard site visits requiring travel and extended assessments trigger the core pathology: post-exertional malaise leaving patients unable to attend subsequent visits or complete patient-reported outcomes. Missed assessments cascade into protocol deviations, reducing trial power and complicating longitudinal data in the most symptomatic patients most critical to retain.

Lindus approach

Lindus deploys hybrid site models shifting follow-up assessments to at-home visits via virtual site staff nurses, reserving clinic visits for medically required procedures. Citrus ePRO/eCOA captures endpoint data within protocol windows independently of site attendance. Patient concierge coordinates remaining in-person visits around individual energy patterns to prevent the triggering that converts visit burden into permanent withdrawal.

Healthcare avoidance in severe phenotypes

Challenge

Severely ill patients withdraw from mainstream medical care because clinic visits trigger crashes. They no longer appear in active clinical databases, and site feasibility questionnaires systematically overestimate available patients. Enrollment projections collapse after activation, forcing mid-study site expansion that extends timelines and inflates operational budgets.

Lindus approach

Lindus queries 40M+ EHR records for patients with historical diagnoses and documents care-engagement drop-off trajectory, identifying where residual touchpoints still exist. Direct-to-patient campaigns reach patients outside clinical channels. Decentralized delivery with virtual site staff extends eligibility assessment to bedbound patients for whom no traditional site model can generate an enrollment event.

Washout requirements driving consent barriers

Challenge

Complex off-label polypharmacy regimens maintain fragile functional baselines. Protocols requiring washout of these agents risk triggering autonomic or pain crises that patients are unwilling to risk for a trial that may not help them. Elevated consent refusal rates result, restricting the enrolled cohort to atypically mild presentations that undermine external validity.

Lindus approach

Lindus stress-tests washout durations against real-world ME/CFS polypharmacy patterns from 40M+ EHR records, identifying which medication classes create the highest refusal risk. Patient concierge coordinators schedule around symptom flare windows, coordinate transport, and maintain sustained contact through washout: converting the unmanaged consent-to-first-visit interval into a supported transition.

Exertion triggers limiting on-site attendance

Challenge

Physical and cognitive exertion required to travel to sites and complete extensive assessments triggers post-exertional malaise, artificially inflating baseline fatigue and cognitive scores at the assessments establishing your efficacy baseline. Missed visits, protocol deviations, and attrition follow: and the remaining cohort trends toward milder phenotypes compressing the detectable treatment effect.

Lindus approach

Hybrid site models shift the majority of fatigue and cognitive assessments to at-home ePRO capture via virtual site staff, reserving clinical visits for procedures requiring a site setting. Citrus ePRO/eCOA captures outcomes remotely with automated reminders, while centralized real-time monitoring aggregates all data streams to surface completeness gaps before they compound.

Healthcare system attrition limiting patient identification

Challenge

Diagnostic dismissal has driven a substantial proportion of long COVID patients to abandon conventional medicine for peer networks or integrative care. They no longer appear in academic medical record systems, and sites relying on standard EHR queries and specialist referral networks miss this population almost entirely: generating feasibility projections that do not survive activation.

Lindus approach

Lindus queries 40M+ EHR records for patients with historical diagnoses and documented care-engagement, identifying patients before drop-off. Direct-to-patient campaigns reach patients who have left traditional care pathways through community and digital channels. Patient concierge coordinators rebuild the trust needed to convert identified patients into enrolled participants despite prior negative experiences.

Rigid diagnostic criteria blocking enrollment

Challenge

Protocols requiring objective confirmation through specialized diagnostics: tilt-table testing, skin punch biopsies, neuropsychological batteries, narrow site selection to tertiary centers and generate elevated screen failures when standard workups return normal. Patients dropping out through prolonged procedural screening sequences deplete a population already reluctant to engage with clinical systems.

Lindus approach

Lindus queries EHR records for patients with documented diagnostic results matching your protocol's phenotype requirements before site referral, concentrating resources on pre-confirmed candidates. Patient concierge coordinates transport and scheduling for procedurally burdensome multi-step screening sequences to prevent the drop-off that accumulates when patients manage complex workup logistics independently.

Specialized assay access delaying enrollment

Challenge

Patients seronegative on standard commercial assays may carry low-affinity antibodies detectable only through live cell-based assays available at a limited number of academic centers. Centralized serology confirmation introduces multi-week delays. Sites without in-house capabilities create screening bottlenecks restricting pre-screening pools and driving screen failures after significant investment.

Lindus approach

Lindus queries documented autoantibody results across 40M+ EHR records to identify patients with confirmed seropositivity before any site contact, maximizing yield from candidates bypassing de novo cell-based assay requirements. Patient concierge coordinates transport and scheduling to centralized serology labs, maintaining engagement through delays that would otherwise generate dropout.

Bimodal demographics creating dual consent bottlenecks

Challenge

Early-onset patients on teratogenic therapies face contraception mandates and washout requirements deterring participation. Late-onset patients carry comorbidity burdens and polypharmacy triggering protocol deviations from non-disease-related adverse events. A single eligibility framework produces distinct consent barriers in each subgroup, suppressing enrollment velocity across both demographics simultaneously.

Lindus approach

Lindus pre-screens each cohort independently using EHR-documented medication histories and comorbidity profiles, identifying early-onset candidates compatible with washout and late-onset candidates whose polypharmacy meets concomitant medication criteria. Patient concierge delivers cohort-specific support: managing washout compliance for younger patients and coordinating transport and scheduling for older participants.

Acute presentations bypassing outpatient screening

Challenge

MuSK-antibody MG frequently presents as an acute bulbar crisis in emergency triage, mimicking stroke or ALS. Initial autoantibody tests may return negative. Rapid deterioration narrows the enrollment window while standard-of-care interventions following hospitalization generate concomitant medication conflicts terminating eligibility before research teams can be deployed.

Lindus approach

Lindus queries EHR records for patients with prior autoantibody testing, documented bulbar symptom patterns, and neuromuscular diagnoses before acute hospitalization. AI-assisted screening pre-qualifies on documented clinical data so sites have candidate files ready to activate the moment an eligible patient is admitted: rather than discovering the patient after the enrollment window has closed.

Unpredictable episodic bout windows

Challenge

Episodic cluster headache bouts are seasonal and self-limiting: patients frequently consent during active pain only for the bout to naturally resolve before randomization. This inflates screen failure rates and creates erratic enrollment tied to seasonal cycles rather than site effort, while spontaneous post-randomization remission mimics efficacy and inflates placebo response.

Lindus approach

Lindus pre-identifies patients with documented cluster headache histories and seasonal bout patterns from 40M+ EHR records, staging outreach to coincide with each patient's predicted bout window. AI-assisted screening pre-qualifies on documented attack frequency, and patient concierge compresses scheduling around bout onset: closing the identification-to-first-visit gap before natural remission occurs.

Preventive washout driving consent refusals

Challenge

Chronic cluster headache patients rely on continuous preventives to manage daily severe pain, and washout of partially effective therapies risks triggering maximum-severity attack spikes. Patients are unwilling to enter an unmitigated pain window, generating high consent refusal rates. Enrolled patients who do attempt washout face acute dropout driven by pain rather than trial design.

Lindus approach

Lindus queries documented preventive medication histories and prior treatment-cycling tolerability to pre-identify candidates more likely to tolerate washout. Patient concierge coordinators deploy direct support through the washout window: coordinating transport during high-severity episodes and maintaining sustained contact to retain participants through the interval where dropout risk is highest.

Phenotypic overlap corrupting eDiary data

Challenge

Endpoint logging of ipsilateral autonomic symptoms during ictal episodes is required precisely when kinetic agitation and acute pain make device operation most difficult. Patients with comorbid migraine may misclassify overlapping symptoms. Retrospective batch entries and misclassified attacks introduce endpoint noise requiring expanded enrollment to accommodate.

Lindus approach

Citrus ePRO/eCOA structures symptom capture with minimal-interaction forced-choice fields for each autonomic symptom, reducing cognitive load during ictal episodes. Centralized real-time monitoring surfaces diary gaps and inconsistent entry patterns same-day, enabling patient concierge coordinators to intervene before ictal non-compliance compounds into systematic endpoint noise.

Therapy washout and livelihood risk

Challenge

Patients maintaining employment and driving privileges through commercial stimulants or sodium oxybate face functional collapse risk from washout. Consent refusal rates are structurally high, and enrolled patients entering washout frequently drop out when cataplexy or sleep attacks return. The cohort skews toward inadequately treated presentations limiting external validity.

Lindus approach

Lindus queries documented medication histories and prior treatment-cycling patterns to pre-identify candidates more likely to tolerate washout. Patient concierge coordinators arrange transport so driving-license risk does not become trial-access risk, manage stipend disbursement to offset lost work time, and maintain daily contact through the washout window where dropout concentrates.

Prolonged in-clinic testing burden

Challenge

Confirmatory endpoints require overnight polysomnography followed by full-day wakefulness testing: a schedule exhausting patients defined by excessive daytime sleepiness and creating employment conflicts. Specialized sleep laboratory infrastructure limits site selection, and missed visits from patients unable to meet the testing schedule leave primary endpoint datasets incomplete.

Lindus approach

Patient concierge coordinators arrange transport to specialized sleep centers, coordinate testing schedules around employment constraints, and administer stipends on visit completion. Site augmentation layers virtual coordinators onto capacity-constrained sleep labs to expand overnight testing throughput without new site activation timelines.

Fragmented care pathways obscuring patients

Challenge

Narcolepsy type 1 patients present with symptoms mimicking mood disorders or sleep-disordered breathing, routing them into psychiatry or pulmonology rather than sleep neurology. Specialty referral networks yield low patient volumes, and the administrative burden of cross-specialty chart review to identify misdiagnosed patients extends enrollment timelines across the program.

Lindus approach

Lindus queries 40M+ EHR records by stimulant prescribing patterns, documented excessive daytime sleepiness, and polysomnography results, going beyond narcolepsy diagnosis codes, to surface misclassified patients across psychiatric and pulmonology records. AI-assisted screening delivers pre-qualified candidates from outside traditional sleep medicine referral channels.

Washout-induced functional collapse

Challenge

CNS-active medications maintaining daily function carry washout risk of profound daytime sleepiness threatening employment and occupational safety. Consent refusal rates are structurally elevated, and the enrolled cohort skews toward mild presentations with limited external validity for a population defined by severe, refractory hypersomnolence.

Lindus approach

Lindus stress-tests washout duration against real-world IH prescribing patterns from 40M+ EHR records. Patient concierge coordinators arrange transport so driving-safety risk is removed, schedule visits around functional capacity, and maintain regular contact through the washout window: targeting the dropout that peaks when patients experience symptom recurrence without pharmacological support.

MSLT limitations driving screen failures

Challenge

Standard daytime nap tests frequently yield false-negative results for continuous-sleepiness phenotypes whose sleep latency falls within normal ranges despite profound daily impairment. Sites exhaust themselves identifying patients who fail at the objective diagnostic gate, while investigator-reported databases overcount by including patients who will fail on protocol-mandated re-testing.

Lindus approach

Lindus queries longitudinal sleep study results, diagnostic code histories, and prescribing patterns to model how many patients in your target geography will actually survive protocol-specific re-testing before site activation. AI-assisted screening pre-screens on confirmed polysomnography data, routing only candidates with documented qualifying values to your sleep labs.

Sleep inertia disrupting protocol compliance

Challenge

Daily morning assessments and first-dose administration require patient action precisely during the prolonged confusion and automatic behavior that characterizes the indication. Patients miss collection windows, disable monitoring devices unconsciously, and mistime doses: generating missing data and protocol deviations at the primary endpoints that matter most.

Lindus approach

Citrus ePRO/eCOA configures endpoint-specific assessments with timed automated reminders calibrated to morning capture windows: prompting completion before cognitive clearing occurs. Patient concierge coordinators proactively contact participants during critical morning windows to guide diary completion and verify dosing. Centralized real-time monitoring flags missed entries same-day for intervention.

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Case study

Enabling a remote, home-dosing visit design for a 25 participant Phase IIa in ME/CFS

Primary and secondary endpoints captured remotely

7 months

To total enrolment for 25 participants

Geographic footprint

Over 160 full-time staff operating across the US, UK, and Europe, with integrated APAC partnerships. Wherever your trial needs to run, the infrastructure is already in place.

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