By Development Phase

Every stage has its own break.

Common scenarios where biotech and pharma programs call Peritia. Organized by program stage, with the function, the trigger event, the timeline pressure, and the outcome we delivered.

STAGE 01

Pre-IND — Discovery to IND.

Translating promising science into a regulated development plan. The most common failure mode is a small company with strong preclinical data and zero experience navigating FDA interactions.

REGULATORY STRATEGY

The Regulatory Architect.

TriggerSeries A biotech has promising in vitro data. No roadmap for FDA interaction. 4 months until a planned pre-IND meeting.
OutcomeFractional VP of Reg Affairs drafts the briefing book and leads the FDA meeting. Secured alignment on tox species + CMC, saving 6 months of redundant testing.
CMC OVERSIGHT

The CDMO Shepherd.

TriggerLead scientist overwhelmed managing a third-party manufacturer for the first tox lot. 3 months to GLP tox start.
OutcomeFractional CMC lead installed technical oversight at the CDMO, caught a purity issue that would have invalidated IND-enabling safety studies.
TOXICOLOGY

The Non-Clinical Interpreter.

TriggerUnexpected mortality in a dose-range-finding study. Board needs a go/no-go decision immediately.
OutcomeFractional toxicologist analyzed raw data, proved the deaths were vehicle-related (not target toxicity), preserving the asset's valuation.
STAGE 02

Phase 1–2 — Proof of concept.

Safety, dose-finding, and the first glimpse of efficacy. The most common calls: CRO oversight gone sideways, adaptive design pressure, and the first serious safety event.

CLINICAL OPERATIONS

The Enrollment Fixer.

TriggerPhase 1b at 20% enrollment after 6 months. CRO unresponsive. 6 months to data readout before cash runway.
OutcomeFractional ClinOps lead took over CRO management, closed underperforming sites, opened three rescue sites, hit the year-end readout.
BIOSTATISTICS

The Adaptive Design Specialist.

TriggerPhase 2 data noisier than expected. Need to pivot to a sub-population mid-stream. 4 weeks until protocol amendment deadline.
OutcomeBayesian adaptive model let the trial continue with a smaller, more targeted n. Saved $4M in unnecessary recruitment.
MEDICAL MONITORING

The Safety Gatekeeper.

TriggerFirst SAE in a First-in-Human trial. 24–72 hours for mandatory regulatory reporting.
OutcomeFractional medical monitor assessed the event, prepared the safety report, coordinated with the DMC to ensure patient safety and trial continuity.
STAGE 03

Phase 3 — Pivotal & registrational.

Massive scale-up, data integrity, and bulletproofing the program for filing. Single points of failure at this stage can cost a year and tens of millions.

CLINICAL OPERATIONS LEAD

The Database Lock Guardian.

TriggerFull-time ClinOps lead resigns for a competitor 3 months before final data snapshot. 90 days to DBL.
OutcomeFractional lead stepped in within 72 hours. Managed final data cleaning, closed all queries, DBL hit on schedule.
GCP QA

The Quality Fixer.

TriggerMock inspection revealed documentation gaps at three high-enrolling sites. 6 months to BLA filing.
OutcomeFractional QA team deployed to sites, performed intensive remediation and TMF reconciliation. Program stayed inspection-ready.
CLINICAL DATA MANAGEMENT

The Data Translator.

TriggerCRO data format incompatible with internal analysis platform. 8 weeks to top-line results.
OutcomeFractional data manager standardized SDTM/ADaM datasets. Biostats ran final TLFs on time.
STAGE 04

Submission — NDA, BLA, MAA.

Synthesizing thousands of pages into a cohesive argument. The most common failure: a "Reg lead" who is a strategist, not a publisher. The fix: specialist medical writers, reg PMs, and reg ops who've done it before.

MEDICAL WRITING

The Narrative Architect.

Trigger40 CSRs need to be synthesized into SCS and SCE. 4 months until eCTD submission date.
OutcomeTwo fractional medical writers managed the entire Module 2/5 drafting, delivered a single-voice submission.
REGULATORY PROJECT MGMT

The Submission Traffic Controller.

TriggerInternal team drowning in version control across CMC, clinical, and non-clinical modules. 12 weeks to filing.
OutcomeFractional Reg PM built the submission tracker, ran daily war-room calls, hit every T-minus deadline.
REGULATORY OPERATIONS

The eCTD Publisher.

TriggerCompany realizes their Reg lead doesn't know how to use the technical publishing software. 30 days to Day 0.
OutcomeFractional Reg Ops specialist formatted, validated, and hyper-linked the eCTD package. Passed the FDA gateway first try.
STAGE 05

Launch — Commercial & access.

Payer access, post-marketing safety, and scientific share of voice. The cost of a missed launch window is measured in quarters of lost revenue.

HEOR / MARKET ACCESS

The Payer Negotiator.

Trigger6 months from PDUFA with no value dossier. Insurance companies need to understand a $100k/year drug.
OutcomeFractional HEOR expert built the cost-effectiveness model and Global Value Dossier. Secured favorable early formulary placement.
PHARMACOVIGILANCE

The Post-Market Safety Builder.

TriggerFDA requires a REMS as a condition of approval. 4 months to PDUFA.
OutcomeFractional PV lead built the adverse event reporting infrastructure and REMS training portal. Compliant day one.
MEDICAL AFFAIRS

The KOL Liaison.

TriggerNo field presence to educate KOLs before launch. 5 months to a major medical congress.
OutcomeFractional VP Medical Affairs recruited and trained a contract MSL team, developed the scientific platform, high-impact congress presence.

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