Capability
Clinical program design
We architect clinical programs so the questions regulators, payers, and clinicians will ask are answered by design—not retrofitted in a CSR footnote. That means tight alignment between estimands, endpoints, the schedule of assessments, and how data will be interpreted across trials and partnerships.
Development costs, competitive windows, and patient recruitment limits make every design choice consequential. For first-in-class assets and novel modalities, off-the-shelf endpoint sets and visit schedules rarely fit; the program must be built as an integrated system of trials, partnerships, and lifecycle claims—not a sequence of disconnected studies.
The development challenge
Clinical development organizations are under pressure to accelerate timelines while improving probability of success. That tension shows up in endpoint debates that drag through multiple protocols, schedules that sites cannot execute, and registrational trials that win approval but leave access teams without the outcomes HTAs expected. Combination programs, co-development deals, and platform technologies add another layer: evidence generated in one study must remain usable for label expansion, partner obligations, and future pooling.
When precedent is weak, the default is often to copy the last similar trial. We help teams replace that reflex with an explicit logic chain—from target product profile and competitive claims to estimands, assessments, and analyses—so medical, statistics, operations, and commercial functions are optimizing the same objective function.
Where we focus
Endpoints, estimands, and success criteria
We define primary and key secondary endpoints, hierarchical testing strategies, and estimand families that match both regulatory expectations and the claims you will need in the market. That includes planning for intercurrent events (rescue therapy, discontinuation, crossover), handling of missing data, and sensitivity analyses that tell a single interpretable story—not a menu of conflicting tables.
Schedule of assessments and operational feasibility
The SoA is where science meets execution. We balance visit intensity against retention, align imaging and biomarker sampling with analysis plans, and surface operational risks early (e.g. specialized labs, pediatric assent windows, decentralized elements). We also ensure the assessments you need for HTA and medical affairs—PROs, work productivity, caregiver measures—are collected at time points that support modeling and labeling, not bolted on as unfunded extras.
Program architecture and trial sequencing
We design multi-trial programs that sequence information value: which studies reduce the largest uncertainties first, where adaptive elements are justified, and how readouts feed into go/no-go decisions for expansion cohorts or new indications. For assets with external partners, we clarify data-sharing, publication rights, and cross-trial pooling before those issues become deal friction.
Combinations, master protocols, and novel modalities
Combination and platform trials require explicit logic for attribution of benefit, control-arm selection, and labeling implications. We help teams structure arms, biomarker-enrichment strategies, and external control plans where appropriate, always tying choices back to what regulators and payers will accept as persuasive—not merely innovative on paper.
What we deliver
- Integrated development plans with clear links between trials, regulatory milestones, and access evidence needs.
- Endpoint and estimand specifications ready for protocol, SAP, and agency discussion—not slide bullets alone.
- SoA drafts and rationale memos with burden metrics, site feedback hooks, and DCT implications where relevant.
- Cross-trial pooling and meta-analysis feasibility assessments to avoid dead-end designs.
- Workshop facilitation across medical, biostatistics, clinical operations, safety, and translational science.
- Competitive landscaping of outcome measures and trial designs in the class, with implications for differentiation.
Outcomes you can expect
- Fewer late-stage protocol amendments driven by unresolved endpoint or estimand ambiguity.
- Stronger alignment between registrational success criteria and the value story market access will need.
- Clearer program-level trade-offs when capital or enrollment forces hard choices among indications or trials.
- A documented design rationale leadership can defend to boards, partners, and agencies.
How we work
We begin with the decisions the program must support—approval, differentiation, reimbursement, and lifecycle extensions—and work backward to evidence generation. lotor lab is built for settings where no borrowed map exists; we facilitate structured debate among functions, then capture conclusions in forms protocols and SAPs can implement.
We partner with your internal medical directors and statisticians rather than replacing them. Our value is synthesis under uncertainty: challenging implicit assumptions, surfacing contradictions between sections, and keeping the thread from TPP through SoA consistent. Engagements range from targeted reviews before a scientific advice meeting to multi-quarter program architecture work alongside portfolio governance.
When teams bring us in
- Indication or asset strategy resets, when legacy endpoints no longer match the competitive or regulatory landscape.
- Complex modalities—gene and cell therapy, tissue-agnostic approvals, digital endpoints—where standard templates fail.
- Pre–protocol finalization, to lock estimands, SoA, and analysis plans before sites and budgets freeze.
- Partnership or licensing negotiations requiring a credible clinical plan both sides can underwrite.