SPHERE — Clinical study & research operations

Who it’s for

Built for biometrics teams who deliver studies

Pharma, biotech, and CRO biometrics — the people who turn clinical trial data into tables, listings, figures, and datasets under inspection pressure.

Lead statistical programmers

Own the study’s programming plan, assign work, and see stage and ownership without a status spreadsheet.
QC programmers

Clear queues of what is waiting for independent QC, with production code read-only and both-run paths when needed.
Biostatisticians

Agree shells to the SAP, review results, and approve release to medical writing with a full change history.
Study & programming leads

Lock shells and datasets after sign-off, watch progress by SAP section, and trust the audit timeline.
Medical writers

Know exactly which outputs are released and final — PDF/Word packages in CSR order, not a folder scavenger hunt.
Data managers & admins

Controlled data landing with checksums, company-wide study layouts, SSO, and module switches — no custom code per customer.

Why teams adopt SPHERE

Replace guesswork with a single source of study truth

Shells in Word, trackers in Excel, programs in email, logs on a server — SPHERE puts the operational picture in one place.

From scattered shells

Mock shells live in Word; post-sign-off changes are hard to spot.

To structured shells — draft, in review, final, locked — with edits blocked after lock.

From spreadsheet trackers

Status sheets updated by hand and often stale by the next standup.

To a live tracker — status moves, runs, and role handoffs update the board as work happens.

From unclear ownership

Nobody is sure who owns QC or statistical review for an output.

To role clarity — production, QC, stats, and medical writing shown on every row; “My assignments” for your queue.

From folder chaos

Each study invents its own folder layout; logs are hard to find after a run.

To a company layout — raw · SDTM · ADaM · programs · TLF · logs applied consistently, with runs and logs one click away.

From fragmented audit

Evidence spread across file servers, email, and spreadsheets.

To one trail — append-only history of shells, workflow, runs, locks, data loads, and assistant suggestions.

From cloud data moves

Many tools ask companies to ship sensitive trial data to a vendor.

To your environment — SPHERE sits on top of the customer’s SAS, R, and file systems; data stays under their IT control.

Biometrics professionals in a corporate office

Built for the way biometrics works

Serious operations, not another status slide

SPHERE sits where programmers, QC, biostatistics, and medical writing already hand work off — so ownership, stage, and audit trail live next to the study instead of in email threads.

One study home for protocol, libraries, and module entry
Shells, tracker, and packages share the same source of truth
Customer environment — trial data stays under their IT control

Capabilities

A fixed spine, optional modules

Sign-in, studies, folder layout, and audit are always on. Adopt Mock Shells first, then Tracker, runs, Define, and packages — each useful alone, better together.

Study home

Protocol metadata, sponsor, cutoff, subjects, SAP status, and delivery targets share one operational picture. Library status across Raw · SDTM · ADaM · Programs · TLF · Logs, plus module entry points — so programmers, leads, and reviewers align without status meetings.

Mock Shells

Build and edit table, listing, and figure shells as a structured sheet: titles, columns, rows, footnotes, analysis sets, and SAP section. Status moves Draft → In review → Final → Locked. Locked shells cannot be changed. Generate Word/RTF with programming notes; send Final shells to Tracker.

Program & TLF Tracker

Every table, listing, figure, and dataset tracked with program, owner, status, shell, and job state. Group by analysis area; filter by type, status, tags, and SAP section. Bulk handoffs and runs. Program headers and QC names generated from shell metadata — no retyping drift.

Runs, queue & logs

Start SAS and R jobs from the Tracker against the customer’s own compute. Watch queue progress, open logs in one click, and keep editable stages separate from read-only review stages — editability follows workflow stage, not check-out theater.

File Explorer & extract

Browse the study folder tree with folder-level access that inherits down the tree. Manual uploads and data-cut snapshots land in raw with checksums and history — so data managers and programmers share one controlled landing zone.

Packages & Define

Assemble PDF and Word packages of locked shells and outputs with a table of contents for CSR or DMC. Draft Define-XML 2.0/2.1 for SDTM/ADaM with human review before release — submission-minded without guessing.

Ask Copilot (governed)

Context-aware suggestions for TLF assist, log QC, and mapping — draft only. Copilot never locks, runs, or publishes. Every accept or reject is audited so a person always stays in control.

Admin & configuration

Modules on/off, branding, SSO, connectors (settings), Tracker workflow, version control, users and teams, study layout, and compliance preferences — one product configured, never a custom code base per customer.

Abstract analytics graphic showing study KPIs and progress bars

Operational clarity

Know what is in QC, locked, or released

Leads see progress by SAP section. Individuals open their assignment queue. Status moves with the work — not a weekly spreadsheet refresh.

Live program & TLF tracker across analysis areas
Role clarity on every row: production, QC, stats, MW
Runs and logs one click from the same board

Study delivery

How work moves from agreed shell to released result

Humans decide; the system records. Workflow stages make editability and next actions obvious.

Shells set the plan

Final mock shells seed Tracker records. Titles, analysis sets, SAP sections, and footnotes become the source of truth for program headers and QC naming — generate, don’t retype.

Roles on every row

Production, QC, stats, and medical writing assignments sit beside status and job state. Leads see progress by SAP section; individuals open “My assignments” for their queue.

Revise without chaos

When something fails QC or stats, the row returns to a revise stage where edits are allowed again — with history of who moved it, when, and why, instead of a silent overwrite.

Packages close the loop

Locked shells and released outputs assemble into PDF/Word packages with a table of contents. Define drafts support SDTM/ADaM review before anything ships to submission teams.

Compliance & audit

Inspection-minded by design

SPHERE is built so validation and quality teams can follow every material decision — without reconstructing history from email.

Append-only audit trail

Creates, edits, locks, generates, workflow moves, runs, data loads, and Copilot decisions land in a searchable, exportable timeline. Tamper-evident history supports inspections and customer validation evidence.

Who acted, on what entity, when
Before/after context for material changes
Sign-in, sign-out, and failed sign-in recorded
Rejected assistant suggestions retained

Customer’s environment, customer’s data Deploy where trial data already lives. SPHERE does not require shipping patient-level datasets to a vendor cloud.
Humans decide; system records Locks, approvals, and releases are always a person. Assistants suggest only.
Locks that mean something Locked shells and gated stages block silent edits. Unlock is an audited action.
Validation-friendly releases Designed so operational qualification evidence can be generated per release for validated requirements.
SSO & study access Company single sign-on, role-based access, and per-study access — leavers lose access with the identity system.
No patient data in the app DB Study datasets stay in the data plane. Operational metadata lives in the application database.

How it works

From study setup to package delivery

Five clear steps — the same rhythm serious biometrics teams already know.

Stand up the study

Create the study from the company layout. Capture protocol, SAP, sponsor, cutoff, and library baselines on Study home.
Author & lock shells

Build mock shells by SAP section, align with biostatistics, move to Final, and lock when agreed.
Track programs & runs

Send shells to Tracker, assign roles, develop and run SAS/R, and move work through QC and stats review.
Release & package

Release outputs to medical writing. Assemble CSR or DMC packages and Define drafts in the same study context.
Prove what happened

Export the audit trail. Show who locked, who approved, who ran what, and which suggestion was accepted or rejected.

Product principles

Designed to earn trust under pressure

The rules behind the interface — so adoption can be gradual and validation can be serious.

One product, configured — differences come from settings and module switches, never a fork per customer.
Fixed spine, optional modules — start with Mock Shells; add Tracker, runs, Define, and packages when ready.
Generate, don’t retype — headers, QC names, folder paths, and auto-numbers derive from the source of truth.
One list, many views — SAP sections, roles, and study details stored once and shown everywhere they matter.
Editability follows stage — programs editable in development and revise; review stages stay read-only.
Plain, accessible UI — readable at zoom, usable in high contrast and by keyboard.

See SPHERE on your next study

Request a walkthrough tailored to biometrics workflows — study home, shells, tracker, and audit with your process in mind.

Request a demo

Serious booth conversation. No invented case studies.

One governed workspace from data to released result.