Dognosis BiosciencesDognosis

Methodology

From operational habit to operational IP.

Our methodology layer accrues automatically as we operate — but only if we write it down. Documentation discipline is what converts know-how into a defensible CRO playbook.

The methodology layer

Six pillars of the operational playbook.

Standard operating procedures

Documented SOPs for breath sample collection in field conditions, cold-chain protocols, sample integrity validation, and QR-based chain-of-custody from camp to laboratory.

CRC training curriculum

A copyrightable training artefact in its own right. Productivity benchmarks, supervision structures, and standardised camp staffing patterns — taught and re-taught against operational data.

Recruitment & retention frameworks

Methods designed for low-literacy and low-trust populations, retention strategies that work where mobile signal is intermittent, and behavioural insights about uptake patterns across communities.

Quality assurance

Frameworks aligned with ICH-GCP and the New Drugs and Clinical Trials Rules, 2019. Robust enough for regulatory scrutiny, grant accountability, and acquirer diligence.

Operational benchmarks

Cost per sample, throughput per CRC, yield rates by geography, dropout patterns. Aggregate operational performance data that compounds across studies.

Tacit operational knowledge

Vendor networks, site selection criteria, community health worker relationships — the kind of knowledge that accrues only through running the operation, codified before it leaves with the people who hold it.

Chain of custody

Sample integrity, end to end.

Every sample carries a verifiable trail from the moment of collection to the moment it reaches the laboratory. The workflow is reproducible across modalities and sponsors.

  1. 1step

    Camp registration

    Participant enrolled, eligibility verified, consent captured.

  2. 2step

    Sample collection

    QR-tagged at point of collection, paired to participant ID.

  3. 3step

    Integrity check

    Phone-camera seal verification, ambient temperature logging.

  4. 4step

    Transport

    Cold-chain protocol with time-stamped handoffs at each leg.

  5. 5step

    Lab intake

    Receipt confirmed against QR; chain-of-custody record closed.

IP architecture

A clean three-bucket allocation.

Built on a single principle: Study-specific IP belongs to the sponsor of the Study, and operational IP belongs to the operator of the Study. Governed by the Clinical Services Agreement that sits beneath every engagement.

Bucket 1

Sponsor IP

Vests in the sponsor

All Study-specific IP — Protocol-derived materials, subject-level diagnostic data, Investigational Test Device performance data, and Study-specific case report form contents — vests with the sponsor of the Study.

Bucket 2

Operational IP

Owned by DBPL

General operational methodology, sponsor-agnostic by design — SOPs, training curricula, camp logistics playbooks, QA frameworks, software systems for clinical operations, and aggregate operational performance data — is owned outright by DBPL.

Bucket 3

Cross-trained software

Owned by DBPL · licensed to sponsor

Where DBPL builds software whose architecture is sponsor-agnostic but whose training data includes Study Data: model architecture and weights are owned by DBPL, while the sponsor receives a perpetual, royalty-free license for use on its own Studies.