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STRATAVERACLINICAL SOLUTIONS
Succeed by design. Execute with certainty.
AI-enabled biostatistics · Protocol optimization · Phase 1–3 execution
Confidential — for discussion purposes only

The cost of a flawed trial is existential.

Biotech companies tend to have limited bandwidth and constrained resources to catch avoidable failure. Trials rarely fail at the end — they fail in the design.

54%
of Phase 3 trials with novel therapeutics fail
Hwang et al. 2016, via Fogel 2018
>40%
of trials amend protocol before Patient 1
Getz et al., via Fogel 2018
Only 31%
of trials meet their enrollment goals
Bower et al., via Fogel 2018
$2.5B+
total cost to bring a drug to market
DiMasi et al. 2015, via Fogel 2018

Design failures

Trials rarely fail at the end — they fail in the design. Flawed endpoints, underpowered studies, and poor patient selection can undermine success before Patient 1 is enrolled.

Execution failures

Site management breakdowns, data quality issues, and regulatory non-compliance destroy trials the science would have won.

At Stratavera, we identify and solve these issues before they become costly amendments, delays, or failed milestones.

Our strategy

Your embedded development team — senior pharma leadership, without the overhead.

01

Optimize before you start

Every protocol undergoes our 12-point clinical protocol inspection, then simulated trials to stress-test population, criteria, and endpoints before a single patient is enrolled.

02

Integrate design and execution

The team that designs your trial also executes it. No re-briefing, no lost context, no waiting on a senior person to become available.

03

Your embedded development team

We function as your in-house clinical development organization — scientific, statistical, and operational leadership normally found only at large pharma.

One partner. Three integrated capabilities.

Stratavera provides the scientific, statistical, and operational leadership your program needs — in one accountable team.

Chief Scientific Officer

Protocol optimization & scientific strategy

  • Development architecture
  • IND/NDA regulatory pathway strategy
  • Therapeutic area & mechanism guidance
  • CRO/CMO selection & oversight
Chief Data Officer

AI-enabled biostatistics & data

  • AI-assisted protocol risk review
  • Statistical analysis plans (SAP)
  • Sample size & power optimization
  • FDA/EMA submission packages
Chief Operating Officer

Clinical execution & operational readiness

  • Phase 1–3 trial management
  • Site selection, activation & oversight
  • GCP/ICH quality systems
  • Audit readiness & regulatory compliance

A founding team that has lived this problem.

100+ combined years across GSK, J&J, Amgen, DURECT, and EpicentRx — a team that has already worked together, across multiple programs.

JS

Jan Scicinski, PhD FRSC

Chief Scientific Officer

38+ years across GSK, ALZA, DURECT, EpicentRx. Led RRx-001 from lead optimization through Phase 3.

84 publications · 22 patents
NA

Nacer Abrouk, PhD

Chief Data Officer

Full biostatistics spectrum worldwide — regulatory submissions and data management across 10+ therapeutic areas.

Multiple NDA/BLA approvals — FDA, EMA, global
COO

Chief Operating Officer

40+ years in clinical operations, regulatory, and quality leadership under active INDs.

GCP/ICH/FDA audit readiness specialist

Why Stratavera

Built to move

Traditional CROs are optimized for volume, not speed. Senior decision-makers are on every call, protocols are optimized upfront, and there are no internal escalation chains slowing your program down.

A pre-proven team. No assembly required.

All three founders have worked together across multiple programs. You're not betting on a team that might work — you're hiring one that already does.

Let's talk about your program.

info@stratavera.solutions +1 650-996-9466 Start the conversation