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Medical Writing

Quality and compliance

Medical claims are traceable, numerical definitions can be checked, and revisions are recorded. Independent quality control is separate from writing; controlled final files are delivered after medical and compliance sign-off.

We assign medical, writing, statistical and specialist review roles according to document type. Quality control staff do not write the documents they review and may withhold release.

01Medical Writing

From requirements to controlled final files

Input requirements, review records and final confirmation are retained for each of the four stages.

  1. 01

    Requirements and authorisation

    Client and project lead

    Confirm the task, materials and conditions of use. The requirement confirmation form specifies deliverable definitions, counting rules, the materials list, authorisation status and schedule.

  2. 02

    Outline and analysis

    Medical and writing leads

    Confirm the scientific structure and analytical definitions, then organise the outline and analysis using the agreed materials.

  3. 03

    Drafting and review

    Specialist review and independent quality control

    Retain drafts, comments and revision records.

  4. 04

    Finalisation and delivery

    Final client confirmation

    Confirm the final version and deliver controlled files, the agreed comment resolution notes and supporting records.

Pharmaceutical client workflow; illustrative workflow
Figure 1Pharmaceutical client workflowIllustrative workflow
Figure caption

Illustrative workflow. Specific milestones are agreed in the requirement confirmation form and work plan.

02Medical Writing

Five checks and evidence traceability

Each medical claim records its source and verification date. The evidence traceability table accompanies delivery and can be reviewed independently of the main text.

Facts and sources
Each claim records a PubMed identifier (PMID), digital object identifier (DOI) or prescribing information section, together with its verification date.
Numerical reconciliation
Totals are checked programmatically and records retained. Effect sizes, confidence intervals and composite outcome definitions are checked for consistency across text, tables, figures and sources.
Compliance
Check the material classification, investigational products and scope of prescribing information. Complete a compliance self-check for each item of external material.
Language and formatting
Check against the client's template, the target journal's instructions for authors or our standard layout.
Delivery completeness
Check the agreed deliverable files, versions and point-by-point comment resolution notes.

The compliance checklist contains 61 items in eight groups, A–H. Each item is checked before external material is delivered. Delivery is withheld while any failed item remains unresolved. Completed checklists are archived and can be provided as agreed in the contract.

Evidence traceability table sample
Figure 2Evidence traceability table sampleIllustrative sample
Figure caption

Each medical claim records its source and verification date. The evidence traceability table accompanies delivery and can be reviewed independently of the main text.

03Medical Writing

Revision rounds and comment resolution

Standard provision includes at least 2 rounds of internal quality control plus 2 rounds of client revisions.

Definition of a round

A round is one consolidated set of client comments; additional comments on the same version are included in that round. Additional rounds are charged at the unit prices specified in the contract, with no unlisted charges.

Comments from multiple parties

The client may consolidate comments into one submission, or submit them separately for us to combine into a single resolution log. Delivery records whether each comment was accepted and why.

Versions and tracked changes

Each version retains tracked changes and a version number, allowing earlier versions to be traced. A list of differences from the previous version accompanies each revision.

Revision response times

We acknowledge comments and provide a handling plan within 1 business day, begin revisions within 2 business days, and return the revised version with point-by-point comment resolution notes within 5–7 business days.

These are revision response times, not first-draft timelines for every document. Drafting timelines depend on data readiness, length and review rounds; a project-specific schedule is set out in the requirement confirmation form.

04Medical Writing

Author responsibilities and publication disclosure

We are not listed as authors. The client and author team determine authorship against the four criteria of the International Committee of Medical Journal Editors (ICMJE).

Our contribution is disclosed in the acknowledgements in line with ICMJE and GPP 2022; we are not listed as authors. Writing and statistical support follows Good Publication Practice 2022. Funding sources are also disclosed truthfully, and an acknowledgements template can be provided. We do not undertake writing that conceals our involvement, sell authorship positions or list anyone who did not contribute.

We do not promise publication outcomes. Acceptance is decided by the journal editorial office and peer review. Evidence traceability tables, quality control logs and compliance checklists are archived individually and can be provided as agreed in the contract.

05Medical Writing

Material classification and boundaries of use

Materials are classified at project initiation and the classification is recorded in the document header. Materials classified as advertising enter the advertising compliance process.

Scientific materials
Non-advertising scientific materials do not present product information as news reporting.
Investigational products
For investigational molecules not yet approved for marketing in China, we make no claims about efficacy, safety or availability. Overseas guidelines and approvals are described only as scientific developments and do not represent registration status in China.
Marketed products
Indications, dosage and administration follow the current NMPA-approved prescribing information. Content outside that scope is excluded from deliverables.
Prerequisites for advertising materials
Under our current working practices, the product classification, intended publications and valid drug advertising approval number must be confirmed. Whether a publication is a designated medical or pharmaceutical professional publication is determined by a written response from the client's legal department or the provincial advertising review authority. We check that response and the placement list; our checks do not replace the response itself. Work does not begin until these prerequisites are met.
Work outside our scope
We do not undertake internet advertising for prescription medicines, or advertising materials for medicines whose advertising is prohibited by law, including narcotic drugs, psychotropic drugs, toxic drugs for medical use and radiopharmaceuticals.

Expert consensus services exclude expert selection and meeting organisation. Drug safety services exclude the collection, assessment and submission of individual case safety reports, and we do not act as the entity responsible for pharmacovigilance.

06Medical Writing

Confidentiality and data handling

A confidentiality agreement is signed before formal engagement. We can use the client's template or provide our own.

Materials are used only for this project and are neither made public nor passed to third parties. Materials classified as confidential or above are shared only within a controlled project workspace, never through public cloud drives or personal email, and are not stored on personal devices. On completion, materials are returned or destroyed as instructed by the client.

Client materials are stored on servers in mainland China. Team members work overseas through remote access to those servers; materials are not downloaded abroad.

The identity layer containing identifiable personal information is held by the client or its designated entity in mainland China. We process only the de-identified portion. If access to identifiable personal information is necessary, separate cross-border processing terms are signed.

07Medical Writing

Use of artificial intelligence tools

Artificial intelligence tools are used only for language editing, formatting and expanding search terms, not to generate medical facts, research data, references or conclusions.

Every claim in a deliverable is checked by a person against the original literature, with an audit trail. References suggested by artificial intelligence are individually checked by PMID/DOI to confirm that they exist and support the content. Client confidential information, unpublished product information and personal information are not entered into any external service.

08Medical Writing

Supplier onboarding documents

The contracting and invoicing entity is 言拓致优(四川)生物医学研究有限公司 (Yanto Health), which can issue a special VAT invoice (增值税专用发票).

Clients can indicate in the request form whether they need a confidentiality agreement and supplier onboarding documents.

Available documents

A business licence copy bearing the company seal, a confidentiality agreement template, a quality control process description, and bank and invoicing details can be provided through the client's supplier onboarding process.

09Medical Writing

Choose standards by document type

The standards reference page lists names, version years and section references. Applicable standards are selected for each project according to the target region, document purpose and client requirements.

Research publications

Authorship, disclosure of involvement and reporting items for the relevant study design.

Clinical development and regulatory affairs

Structural requirements for clinical trial protocols, investigator's brochures, clinical study reports and the common technical document. Nonclinical common technical documents (ICH M4S(R2)).

Specialist evidence materials

Applicable standards for drug safety, health economics and medical device clinical evaluation documents.

Get started · Submit a request

Submit a medical writing request

Please provide the document type, quantity, project stage, intended use, available materials and deadline requirements. We first issue a requirement confirmation form, followed by an itemised quote and schedule.

Submit a medical writing requestReply within 24 hours (business days first) · contact@yantohealth.cn