Description
Primary Manuscript Development (Phase 2/3 Trials)
GPP 2022-aligned development of the primary publication for pivotal Phase 2/3 clinical trial results. We prepare an ICMJE-compliant manuscript that communicates your trial outcomes transparently and ethically, and we support the authors from author guideline development through journal selection, submission, peer review response and post-acceptance production.
Service Details
| Timeline | Standard: 10-14 weeks | Fast-track: 6-8 weeks |
| Best for | The primary publication of pivotal Phase 2/3 clinical trial results |
| Standards | GPP 2022, ICMJE, CONSORT 2010, COPE |
| What you receive | A complete primary manuscript with structured abstract, tables, figures and supplementary materials, a completed CONSORT checklist, and author support through submission, peer review and post-acceptance production |
Compliance Framework
- GPP 2022 – Good Publication Practice guidelines
- ICMJE – Authorship and disclosure requirements
- CONSORT 2010 – Randomized trial reporting
- COPE – Publication ethics guidelines
Manuscript Components
- Structured abstract (CONSORT format)
- Introduction with rationale
- Methods (design, participants, interventions, outcomes, statistics)
- Results (participant flow, outcomes, ancillary analyses)
- Discussion (interpretation, limitations, generalizability)
- Tables and figures
- Supplementary materials
Author Support Services
- Author guideline development
- Statistical liaison coordination
- CONSORT checklist completion
- Journal selection and submission
- Peer review response support
- Post-acceptance production
Ethical Standards
All contributors meeting ICMJE criteria are acknowledged as authors. Medical communication support is disclosed per GPP 2022. Clinical trial registration verification is included.
How It Works
- Send us your trial results and documents, plus your target journal if you have one
- We develop the author guidelines and draft the manuscript, coordinating with your statisticians on the analyses
- The authors review each draft, and we revise based on their feedback
- We complete the CONSORT checklist, then support journal selection, submission, peer review responses and post-acceptance production
Which Service Do You Need?
This service is for the primary publication of a pivotal trial. For subgroup, exploratory or post-hoc analyses of the same trial, see Secondary & Post-Hoc Analysis Manuscripts. To present the results at a medical meeting, see Scientific Congress Abstract. To plan publications across a whole clinical program, see Strategic Publication Planning.
Try It Free First
Want to sketch your CONSORT participant flow diagram before ordering? Try our free Reporting Guideline Flow Diagram Generator.
Frequently Asked Questions
How long does primary manuscript development take?
The standard timeline is 10-14 weeks. The fast-track timeline is 6-8 weeks.
Which guidelines does the manuscript follow?
GPP 2022 (Good Publication Practice), ICMJE authorship and disclosure requirements, CONSORT 2010 for randomized trial reporting, and COPE publication ethics guidelines. The abstract is structured in CONSORT format and we complete the CONSORT checklist.
How is authorship handled?
All contributors meeting ICMJE criteria are acknowledged as authors, and medical communication support is disclosed per GPP 2022.
Is clinical trial registration checked?
Yes. Clinical trial registration verification is included.
Does support end at submission?
No. The service also covers peer review response support and post-acceptance production.
Get started: add this service to your cart, or email co*****@*******se.com with your trial details and target journal.
