Medical Writing · CSR · Protocol · CER · Safety Narratives · Clinical Ops

Clinical Services

Clinical documentation and operations delivered by medical writers, biostatisticians and clinical operations leads — accelerated with TraceDraft where every AI-drafted sentence links back to the source data behind it.

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medical writing servicesCSR authoring servicesprotocol writing servicessafety narrative servicesclinical evaluation report servicesCER servicesliterature review servicesclinical operations

FDAEMAMHRAPMDACDSCOGAMP 5ICH Q921 CFR Part 11

In short

Clinical services cover the documents and operations a trial depends on — medical writing, study reports, protocols and amendments, safety narratives, clinical evaluation reports and clinical operations. The recurring constraint is writer capacity rather than data availability: the tables exist, and the number of qualified people able to turn them into regulated prose does not flex.

7 disciplines

Every clinical discipline we deliver

Each one has its own page with scope, deliverables and timelines.

Medical Writing Services

Full medical writing team on-demand — regulatory-grade documents, ICH-aligned templates, and traceability built into every deliverable.

Learn more about Medical Writing Services Clinical Study Report (CSR) Authoring

End-to-end CSR authoring with the safety-narrative appendix drafted straight from the AE listing and SAS datasets — a single provenance graph, one review workflow.

Learn more about Clinical Study Report (CSR) Authoring Protocol & Protocol Amendment Writing

Trial protocols and amendments authored, versioned and traceable — with amendments inheriting the audit trail rather than living in tracked-changes.

Learn more about Protocol & Protocol Amendment Writing Clinical Documentation Services

IB, DSUR, IND annual, HAQ responses, IND packages, and study documents — sourced from your AE listings, SAS datasets and protocols with provable traceability.

Learn more about Clinical Documentation Services Safety Narrative Writing

Standard-template narratives — Patient ID, AE Description, History, Study Drug, Clinical Course, Causality, Summary — each section wired to the required source types.

Learn more about Safety Narrative Writing Clinical Evaluation Reports (CER)

Clinical Evaluation Reports authored with the same source-traceability engine used for CSRs — traceable claims, tamper-evident audit, MDR-ready evidence.

Learn more about Clinical Evaluation Reports (CER)Clinical Operations Services

Site feasibility, essential documents, monitoring plans, TMF quality — with AI augmentation on the documentation-heavy parts of the workflow.

Learn more about Clinical Operations Services

Draft safety narrative

Source data

1Adverse event listing · row 14
2Lab dataset · ALT value, day 15
3Protocol · section 7.2

Check the source, not the sentence

In a source-traceable clinical document, each statement links to the listing row, dataset value or protocol clause it came from, so a reviewer checks the source instead of trusting the sentence.

Case study · CRO

TraceDraft at a mid-cap CRO

A mid-cap CRO's medical writing team was capacity-bound on CSR turnaround.

Read the case study

14Active studies in production use

SourceEvery statement linked to its dataset row

ApprovedBy every sponsor for AI-assisted writing

5xFaster safety narrative appendices

Tell us what you need from clinical.

A clinical lead reviews your situation and proposes the smallest scope that does the job properly.

We reply within one business day
We look at your situation before we quote
You get a clear plan and scope

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Clinical Services

Every clinical discipline we deliver

TraceDraft at a mid-cap CRO

Tell us what you need from clinical.

Talk to a clinical lead