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Medical Writing

Service directory

Services are grouped into Medical Affairs, research publications and clinical development. Evidence and statistics, and medical review and quality control, support all three areas and can also be commissioned separately.

01Medical Writing

Find services by document type

Find services by document type
Document / serviceService areaDeliverablesPricing basis
Scientific slidesMedical affairs and medical educationFinal slides, speaker notes and evidence traceability tablePriced per item. Cover slides, closing slides and section-title transition slides are not charged; the general layout template counts as 0 slides in total.
Clinical position papersMedical affairs and medical educationNarrative document and evidence traceability tablePriced per item.
Disease education and scientific news articlesMedical affairs and medical educationManuscript and evidence traceability tablePriced per item.
Topic briefs, medical Q&A and content maintenanceMedical affairs and medical educationBriefs, Q&A documents and updated materialsIndividual articles are priced per item; ongoing maintenance can be arranged as a long-term engagement with dedicated monthly staffing.
Expert consensusMedical affairs and medical educationEvidence summaries, consultation materials, comment resolution records and consensus reportWe first issue a requirement confirmation form, followed by an itemised quotation.
Research trainingMedical affairs and medical educationTopic list, training slides, invitation letter and agenda templatesPriced per item.
Digital medical contentMedical affairs and medical educationScientific content, page drafts and drafts for reviewWe first issue a requirement confirmation form, followed by an itemised quotation.
Medical information Q&A (MI)Medical affairs and medical educationStandard Q&A documents, evidence traceability table, reference list and version update logWe first issue a requirement confirmation form, followed by an itemised quotation.
Manuscript writing supportResearch publicationsManuscript, results tables and figures, standards checklist, evidence traceability table and comment resolution recordPriced per item or per project, covering data processing, manuscript preparation, submission and revision support for a single study. Acceptance is decided by the journal. We do not promise publication outcomes.
Conference abstracts and postersResearch publicationsAbstract draft, poster source files and final version, standards checklist and evidence traceability tablePriced per item, with separate quotations for abstracts and posters.
Translation and language editingResearch publicationsGlossary and tracked-changes documentPriced per item.
Journal submission supportResearch publicationsCandidate journal list and draft methodological responsesPriced per item.
Publication planResearch publicationsPublication plan, content mapping table, proposed timeline, author communication and review schedule, and disclosure checklistWe first issue a requirement confirmation form, followed by an itemised quotation.
Preclinical research papersResearch publicationsManuscript, results tables and figures, ARRIVE 2.0 checklist and evidence traceability tablePriced per item. Acceptance is decided by the journal. We do not promise publication outcomes.
Clinical trial protocols and informed consent forms (Protocol/ICF)Clinical development and regulatory affairsClinical trial protocols and amendments, and draft informed consent formsWe confirm the scope of the engagement before quotation.
Investigator's brochure (IB): first edition and updatesClinical development and regulatory affairsFirst-edition investigator's brochure draft (recommended as a joint engagement) and updatesWe confirm the scope of the engagement before quotation.
Clinical study reports and safety event narratives (CSR)Clinical development and regulatory affairsDraft clinical study report and safety event narrativesWe confirm the scope of the engagement before quotation.
CTD clinical documents and responses to regulatory questions (CTD 2.5/2.7)Clinical development and regulatory affairsDraft CTD clinical documents and supporting drafts for responses to regulatory questions (recommended as a joint engagement)We confirm the scope of the engagement before quotation.
Regulatory meeting briefing packagesClinical development and regulatory affairsDraft meeting briefing packageWe confirm the scope of the engagement before quotation.
Drug safetyClinical development and regulatory affairsDraft periodic reports, safety specification and pharmacovigilance plan sections, and signal assessment reportsPriced per item. We first issue a requirement confirmation form, followed by an itemised quotation.
Health economicsClinical development and regulatory affairsEvaluation protocol, analysis report, parameter review, manuscript, executable model and economic sections of a value dossierWe first issue a requirement confirmation form, followed by an itemised quotation.
Medical device clinical evaluation (CER/PMCF)Clinical development and regulatory affairsEvaluation plan, search documents, clinical evaluation report, post-market clinical follow-up documents, summary of safety and clinical performance, and clinical evaluation materials for registration in ChinaWe first issue a requirement confirmation form, followed by an itemised quotation.
Nonclinical documentsPreclinical research and IND applicationsClinical development and regulatory affairsDraft CTD 2.6 nonclinical written and tabulated summaries, draft CTD 2.4 nonclinical overview (recommended as a joint engagement), and draft nonclinical study reportsWe confirm the scope of the engagement before quotation.
Literature searchesEvidence and statisticsSearch strategy, database-specific search logs, eligible reference list and bibliographic tablePriced per item.
Field evidence reviewsEvidence and statisticsStratified evidence summariesPriced per item; ongoing updates can be arranged as ongoing content support.
Meta-analysis, survival analysis and prediction modelsEvidence and statisticsAnalysis code, results tables and figures, methods description and standards checklist; includes systematic reviews and meta-analyses of preclinical animal studiesPriced per item; where the client writes the manuscript, statistical review alone can be commissioned.
Target evidence reviews and competitive landscape reportsEvidence and statisticsStructured evidence review and pipeline table for the same target (with public sources and search dates)Priced per item.
Statistical analysis and statistical review of preclinical experimentsEvidence and statisticsReview comments on experimental design and sample size, analysis code, and results tables and figuresPriced per item; where the client writes the manuscript, statistical review alone can be commissioned.
Numerical and reporting consistency checksMedical review and quality controlReview comments and suggested revisionsPriced as review only, where the client writes the manuscript and we provide only methodological, statistical or compliance review.
Checks on interpretive limitsMedical review and quality controlReview comments and suggested revisionsPriced as review only.
Comment resolution recordsMedical review and quality controlPoint-by-point record of responses to commentsPriced as review only or as an item within the relevant project quotation.

For regulatory submission documents, see the clinical development and regulatory affairs page for the statuses Can take on, Recommended as a joint engagement and Not taken on. A listing in this directory does not imply unconditional acceptance of an engagement.

Currently showing 31 services

02Medical Writing

Development stages and corresponding documents

Documents and tasks are listed by the product's development stage.

Development stages and corresponding documents
Development stageCorresponding documents and tasks
① Target discovery and validation
Target evidence reviews and competitive landscape reports for the same target;Systematic reviews and meta-analyses of target-related evidence.
② Preclinical research and IND applications
Statistical analysis and statistical review of preclinical experiments, preclinical research papers, and nonclinical study report writing support;CTD 2.4 nonclinical overview and 2.6 nonclinical summaries;First-edition investigator's brochure and lead writing for the initial IND clinical trial protocol (both recommended as a joint engagement);Regulatory meeting briefing packages.
③ Clinical development (phases I–III)
Clinical trial protocols and amendments, and informed consent forms;Annual investigator's brochure updates;Clinical study reports and safety event narratives;Development safety update reports (DSUR);Publication plan (usually from phase II), manuscript writing support, conference abstracts and posters, journal submission support, and translation and language editing;Health economic evaluation protocols and models (from phase III);Scientific slides, Clinical position papers, and disease education and scientific news articles.
④ Marketing authorisation application and review
CTD 2.7 clinical summary;CTD 2.5 clinical overview and supporting drafts for responses to regulatory questions (recommended as a joint engagement);Safety specification and pharmacovigilance plan sections of the risk management plan;Cost-effectiveness and budget impact analysis reports, and economic sections of a value dossier.
⑤ Post-marketing
PBRER/periodic safety update reports, risk management plan updates and signal assessment reports;Protocols, informed consent forms and clinical study reports for post-marketing studies;Post-marketing research papers and publication plan updates;Health economic evaluation papers;Medical information Q&A, topic briefs and content maintenance, expert consensus, and digital medical content.
Across the lifecycle
Evidence and statistics (literature searches, Field evidence reviews, meta-analysis, survival analysis and prediction models, and statistical review);Medical review and quality control (numerical and reporting consistency checks, checks on interpretive limits, and comment resolution records);Research training.
Medical device pathway
Pre-market: clinical evaluation plan (CEP), search strategy and search report, clinical evaluation report (CER), and clinical evaluation materials for registration in China;Post-market: PMCF plans and evaluation reports, informing CER updates. CER evaluators are appointed by the client and sign the report.
Pharmaceutical development stages and document roadmap; coloured dots indicate commissioning departments, with a text equivalent in the table in this section
Figure 1Pharmaceutical development stages and document roadmapIllustrative workflow
Figure caption

Illustrative workflow. Documents are listed by the product's development stage; coloured dots indicate commissioning departments. Protocols, investigator's brochure updates, DSUR, clinical study reports and research publications recur as development progresses. The stages shown do not imply fixed delivery timelines. Applicable stages for medical information Q&A, drug safety, health economics and medical device evaluation are confirmed for each project.

03Medical Writing

Frequently asked questions

Stage of involvement

Clients can choose when to engage us according to the product's stage. At the target or preclinical stage, work can begin with target evidence reviews, preclinical statistics and nonclinical documents. During clinical development, it can begin with protocols, investigator's brochure updates and DSUR. After pivotal trials, it can begin with clinical study reports, evidence and statistics support, and research publications. At marketing authorisation application or after approval, it can begin with CTD clinical documents, drug safety, health economics and Medical Affairs materials. At the target and preclinical stages: We do not conduct experimental (laboratory or animal) studies. The scope is set out in a requirement confirmation form before project initiation.

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Please provide document types, quantities, the current stage, intended use, available materials and deadlines. We first issue a requirement confirmation form, followed by an itemised quotation and schedule.

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