Description
<![CDATA[
Primary Manuscript Development (Phase 2/3 Trials)
GPP3-aligned primary publication development for pivotal clinical trial results. ICMJE-compliant manuscript preparation ensuring transparent, ethical scientific communication of trial outcomes.
Compliance Framework
- GPP3 – 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 acknowledged as authors. Medical communication support disclosed per GPP3. Clinical trial registration verification included.
Timeline
Standard: 10-14 weeks | Fast-track: 6-8 weeks
]]>
