From hypothesis to executable protocol
A decentralized protocol must be approvable by regulators and executable by participants at home. Alethium resolves endpoints, feasibility, statistics, and operations before the protocol locks, then translates them into the rules that govern execution.
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Protocol Development
Full protocol authoring, from synopsis through final, including amendments. Our writers work alongside the operations team that will run the study, so design decisions are pressure-tested against execution before they reach a regulator.
Endpoint & Assessment Strategy
Primary and secondary endpoints selected for statistical power and operational reality, with instrument selection, licensing, and scoring logic settled during design rather than discovered at startup.
Feasibility
Participant-perspective feasibility establishes whether the population will enroll and remain enrolled, and site feasibility confirms execution where a protocol requires it. Testing both before the protocol locks prevents the amendments that follow slow enrollment.
Statistical Design
Sample size, randomization strategy, and analysis approach defined at design, with the statistical analysis plan authored to match the protocol exactly.
Risk-Based Design
Critical-to-quality factors identified during design, not retrofitted during conduct. Risks are ranked by impact on participant safety, data integrity, and timelines, and the monitoring strategy is built around them.
Operational Design
Visit schedules, decentralized and hybrid pathways, and participant burden modeled as part of the protocol. Every remote procedure, televisit, lab test and home shipment is designed as a workflow.
Statistical Design
Sample size, randomization strategy, and analysis approach defined at design, with the statistical analysis plan authored to match the protocol exactly.
Risk-Based Design
Critical-to-quality factors identified during design, not retrofitted during conduct. Risks are ranked by impact on participant safety, data integrity, and timelines, and the monitoring strategy is built around them.
Data Standards from Day One
CDISC-aligned data structures defined during design, so datasets are submission-ready by construction rather than remediated at database lock.
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Data Standards from Day One
CDISC-aligned data structures defined during design, so datasets are submission-ready by construction rather than remediated at database lock.
Living Documentation
Protocol requirements are expressed in plain-language Behavior-Driven Development scenarios that sponsors, sites, and Alethium share as one rule set, continuously validated by automated tests so the protocol and the system never drift apart.
Designed. Validated. Executable.
A protocol that pass regulatory review and operational reality.
FAQs - Common Questions
Yes. Alethium provides full protocol authoring from synopsis through final version, including amendments, along with the supporting documents a submission requires. Protocols are written by specialists working alongside the team that will run the study, so operational feasibility is tested during design rather than discovered at startup. Protocol authoring is delivered as part of a study engagement.
Yes. Decentralized and hybrid pathways are modeled during design rather than added later. Televisits, home shipments, remote assessments, and site visits are each specified as workflows with defined triggers, so the operational design is complete before the protocol is submitted.
Amendments usually trace to design assumptions that failed in the field: unrealistic eligibility criteria, burdensome visit schedules, or endpoints that cannot be collected as specified. Alethium tests those assumptions during design through feasibility and operational modeling, and expresses protocol rules as automated, continuously validated scenarios so drift is detected immediately.
Writing produces the document; design determines whether the study will work. Alethium does both together — endpoint selection, sample size, visit schedule, and risk strategy are decided as design questions, then written into a protocol whose requirements map directly to the workflows that will execute them.
Risk-based design identifies critical-to-quality factors during protocol development and builds monitoring and quality controls around them, in line with ICH E6 expectations. Alethium ranks risks by impact on participant safety, data integrity, regulatory compliance, and timelines, then designs the oversight strategy to match.
Alethium leads with participant-perspective feasibility: prospective participants indicate whether the population will enroll and remain enrolled, which is the constraint that determines whether a decentralized study fields. Site feasibility runs alongside it wherever a protocol requires site procedures. Testing both before the protocol locks prevents the amendments that follow slow enrollment.