Fram Analytics

Charting the unknowns of clinical development.

Strategic insight, quantitative science, and AI for drug development. Define what to develop, optimize trial design, and build the evidence to convince regulators, partners, and investors.

Talk to us See how we help

I need help with: clinical development plan dose selection and trial design regulatory interaction due diligence

One decision, simulated300 virtual patients, PK model
efficacy threshold safety ceiling
Dosing interval
–in the target window
–below efficacy threshold
–above safety ceiling
Illustrative models of a hypothetical drug. Real programs use models built from your data.
30+years in drug development
200+programs supported
50+regulatory filings
20+diligence and partnering reviews
Experience from
  • Amgen
  • BMS
  • AstraZeneca
  • McKinsey

Four decisions, repeated at every stage.

Each one is made with incomplete information. We bring the evidence and the modeling to make them with confidence.

Design

Indications, endpoints, trial designs and development plans.

Dose

Doses and regimens grounded in exposure, response and simulation.

Decide

Go, no-go, partner or invest, with quantified risk and upside.

Defend

The case to regulators, partners, boards and investors.

Inspired by a ship built for the unknown.

Fram, Norwegian for “forward,” carried Nansen across the Arctic, Sverdrup through the Canadian Arctic and Amundsen to the South Pole. Designed and built to be lifted by the ice rather than crushed, she ventured into the unknown and returned intact.

Bringing a new therapy to patients is a voyage of its own. We work the way Fram sailed.

85°57′N

Farthest north, 1895, drifting with the Arctic ice.

78°41′S

Farthest south, 1911, on the way to the South Pole.

Nansen read an unseen current from wreckage that drifted across the Arctic.

Read the hidden current

We model what your data, published trials and precedent imply, not just what they show.

Fram’s hull was shaped so crushing ice would lift her, not break her.

Build for the pressure

Plans and analyses built to withstand scrutiny from regulators, partners and investors.

Amundsen laid supplies along the route before the final push.

Test the route first

Doses, designs and scenarios simulated before you commit patients and capital.

Support at every stage of the journey.

Set the course before the first patient.

Which indication, which starting dose, which regulatory path. A plan regulators and investors can follow.

We deliver

  • Target product profile and development plan
  • First-in-human dose projection
  • Pre-IND strategy and briefing document

Stages advance automatically. Select one to pause.

What we do

Clinical and regulatory strategy

Development plans, target product profiles, regulatory pathways and agency meetings.

Trial design and quantitative analytics

Trial simulation, dose selection, modeling, evidence synthesis and probability of success.

Due diligence and partnering

Independent asset assessment, competitive landscape, and materials for partners, boards and investors.

Data science and AI

Automated pipelines, AI-assisted evidence extraction and interactive decision tools.

AI does the heavy lifting. Experts own every answer.

We use AI for the repetitive, high-volume work around a decision. The judgment stays with experienced drug developers.

Your trial data Published trials Regulatory precedent Competitor programs Real-world evidence Models + AI expert-reviewed Dose and regimen Trial design and PoS Go / no-go, partner, invest Briefing documents

Evidence in, decisions out. Automated pipelines and AI assemble and screen; experts model, judge and sign.

Expert-reviewed, always Every result traces to its source file and field Independent QC De-identified before any AI model sees it Zero data retention by AI providers, enforced in code Every number from validated code, never from a model Aligned with FDA’s draft AI guidance

Ways to work with us

Defined projects

A development plan, a design package, a model or a briefing document. Fixed scope, timeline and budget.

Embedded partnership

An ongoing strategic and quantitative function alongside your clinical, regulatory and leadership teams.

Due diligence

Independent evaluation of an asset or data package for licensing, investment and board decisions.

How a project runs

  1. Scoping call
  2. Written proposal
  3. Agreed approach
  4. Analysis and review
  5. Deliver and support

A small, senior crew on every project.

Fram Analytics is a team of clinical development veterans, statisticians, and computer science and AI experts, with experience spanning large pharma, biotech and top-tier consulting.

You work directly with the people doing the work. The person who builds the analysis is the one who presents it to your board and stands behind it with regulators, partners and investors.

  • Based inPleasanton, California
  • ClientsBiopharma companies, investors and partners
  • TeamClinical development, biostatistics, pharmacometrics, computer science and AI

Tell us where you are headed.

We reply within two business days to set up a confidential conversation.

Or email info@framanalytics.com

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