Study-corpus intake
Load clinical, non-clinical, safety, and regulatory folders without flattening away the study, page, section, and file lineage reviewers need.
Pharma FDA submission workspace
Spot inconsistencies before FDA does.
Ingest clinical study corpus. Search inter-study consistency. Flag discrepancies before submission. Every finding cites the study + page + section.
Built for regulatory affairs, clinical operations, pharmacovigilance, and submission quality teams that need evidence before the package leaves the sponsor.
Inter-study consistency
Compare endpoints, populations, safety tables, and protocol deviations.
Clinical + non-clinical corpus
Review CSRs, non-clinical reports, protocols, SAPs, and summaries together.
Study + page + section cites
Keep each discrepancy candidate tied to the source text reviewers inspect.
Submission discrepancy queue
Prioritize contradictions before they become health authority questions.
10 MCP clients / registered tools
Use the AI client already approved by the team with local-first citations.
The submission-risk backlog
The study package can contradict itself before review starts.
A submission package spans clinical study reports, non-clinical studies, protocols, statistical analysis plans, safety narratives, tables, and module summaries. A single inconsistent endpoint, adverse event count, inclusion criterion, or subject-disposition statement can turn into a reviewer question. Leapable gives reviewers a cited queue of candidate discrepancies before the package leaves the sponsor.
60-second pharma demo
Study corpus in. Discrepancies flagged. Source opened.
Demo flow: add a submission folder, ask consistency questions across clinical and non-clinical studies, triage discrepancy candidates, then open the cited study page and section before escalating.
Input
CSRs, non-clinical reports, protocols, SAPs, safety narratives, and eCTD modules.
Ask
Which endpoints, populations, adverse event counts, and deviations conflict?
Output
Cited discrepancy queue with study, page, section, excerpt, and status.
Transcript pending until the pharma submission review walkthrough is uploaded.
Capabilities
Four jobs for source-cited submission review.
Inter-study consistency checks
Compare endpoints, inclusion criteria, subject disposition, adverse events, lab values, dosing, and protocol-deviation language across reports.
Submission discrepancy queue
Route candidate contradictions by severity, status, source set, and reviewer owner before the package enters final QC.
Safety signal evidence map
Trace adverse event summaries, narratives, integrated tables, and source reports without treating generated summaries as the source of truth.
Typical workflows
Pharma review tasks that need source discipline.
01
eCTD consistency sweep
Compare module summaries against clinical and non-clinical source reports, then open cited pages before assigning remediation work.
02
Clinical endpoint trace
Follow primary and secondary endpoint claims from protocol to SAP, CSR, tables, listings, and submission narrative.
03
Pharmacovigilance review
Link safety narratives, integrated adverse event tables, and supporting study text so every escalation keeps the evidence attached.
Competitor context
RIM and validation systems manage submissions. Leapable checks the evidence layer.
| Capability | Veeva | Certara P21 | ArisGlobal | IQVIA | Ennov | Leapable |
|---|---|---|---|---|---|---|
| Primary fit | Regulatory submissions content management and Veeva RIM platform. | Clinical data standardization, validation, and submission deliverables. | End-to-end LifeSphere regulatory, safety, and R&D compliance platform. | AI-enabled SmartSolve RIM for regulatory information and compliance. | RIM, dossiers, regulatory workflows, and embedded life-sciences AI. | Local-first cited AI workspace for study-corpus consistency review. |
| Review surface | Plans, authors, reviews, approves, and tracks submission documents. | Validates datasets and manages clinical-data issues against standards. | Unifies regulatory data, content, submissions, intelligence, and safety. | Centralizes registration data, submissions, correspondence, and documents. | Centralizes products, registrations, submissions, correspondence, and tasks. | Study, page, section, excerpt, and provenance chain for each finding. |
| Study-page-section discrepancy queue | No public Leapable-style queue claim found. | Public pages emphasize dataset validation and issue management. | Public pages emphasize RIM, regulatory intelligence, safety, and automation. | Public pages emphasize RIM, compliance, and submission management. | Public pages emphasize RIM workflow, dashboards, and document links. | Yes: every finding cites the study, page, section, and excerpt. |
| MCP-native / BYO LLM | No public MCP-native claim found. | No public MCP-native claim found. | No public MCP-native claim found. | No public MCP-native claim found. | No public MCP-native claim found. | Yes: BYO LLM, 10 MCP client configurations, and the registered MCP tool surface. |
| Public deployment posture checked May 30, 2026 | Cloud platform; no public local-first client-vault claim found. | Enterprise platform and central workspace; no local-first claim found. | SaaS regulatory platform; no public local-first claim found. | Cloud-based SmartSolve RIM on Microsoft Azure. | Public cloud or on-premises deployment options. | Local-first vault; cloud workflows are explicit opt-ins. |
| Public pricing checked May 30, 2026 | No public plan price found. | Contact sales / book demo path; no public plan price found. | Contact form path; no public plan price found. | Contact / demo path; no public plan price found. | Contact path; no public plan price found. | Builder $49, Pro $99, Elite $2,000. |
Sources checked: Veeva Submissions, Certara Pinnacle 21, ArisGlobal LifeSphere, IQVIA SmartSolve RIM, and Ennov RIM. Competitor claims and pricing are public-page readbacks as of May 30, 2026.
Pricing
Pricing for submission review, safety evidence, and rollout planning.
Builder fits an individual reviewer testing one corpus. Pro adds credits and API access for repeat workflows. Elite supports governed rollout planning, onboarding, and white-glove support for larger teams.
Trust and FAQ
FDA-facing answers need strict evidence boundaries.
Does Leapable replace Veeva, ArisGlobal, Ennov, IQVIA, or Certara?
No. Leapable prepares cited discrepancy evidence for review. The validated RIM, publishing, safety, quality, and clinical data systems remain the systems of record.
Can it cite study, page, and section for every finding?
Yes. Ask from the local vault and inspect the cited source file, page, section, and excerpt before treating a discrepancy candidate as actionable.
Can it compare clinical and non-clinical reports?
Yes. Add CSRs, non-clinical studies, protocols, SAPs, safety narratives, tables, and module summaries, then ask consistency questions across the corpus.
Does it provide medical or regulatory advice?
No. Leapable organizes evidence and flags source-cited inconsistencies. Qualified sponsor teams own medical, safety, legal, and regulatory judgments.
Final CTA
Turn the study corpus into a cited discrepancy workspace.
Install Leapable, add one sanitized study folder, and review the first inconsistency with source study, page, section, and excerpt attached.