EditverseClinical study protocol
from $400See levels and order
A protocol fixes the question, the participants, the endpoints and the analysis before the first participant is enrolled. This service supports that document at three depths. It is for investigators planning an investigator-initiated study, and for sponsors and contract teams that need a protocol written to current guidance.
Specification
- You provide
- The study concept, target population, intended endpoints, site and sponsor details, and any existing protocol, synopsis or ethics correspondence.
- We do
- Review the design choices (comparator, endpoints, allocation, follow-up, sample size approach), record recommendations, check an existing protocol item by item, or write the protocol in full.
- You receive
- Protocol synopsis: design recommendations in synopsis form. Protocol review: a completed SPIRIT 2025 checklist and a protocol paper for journal submission. Full protocol: protocol with schedule of assessments, statistical section and synopsis.
- Standard applied
- SPIRIT 2025 statement (34-item checklist and schedule diagram); ICH E6(R3) Good Clinical Practice, Principles and Annex 1; ICH M11 protocol template structure for regulatory protocols; ICH E9(R1) for estimands.
- Turnaround
- Protocol synopsis 5 business days. Protocol review 10 business days. Full protocol: schedule given with the quote.
- Revision rounds
- Protocol synopsis 1 round. Protocol review 1 round. Full protocol 2 rounds.
- Team
- A medical writer experienced in clinical documents, a subject-matter expert (MD or PhD in the therapeutic area), and a statistician.
Levels
Two levels can be ordered directly. The full protocol is by quote.
| What is included | Protocol synopsis $400 | Protocol review $800 | Full protocol, by quote |
|---|---|---|---|
| Study design consultation | |||
| Written recommendations in synopsis form | |||
| Item-by-item check against SPIRIT 2025 | |||
| Protocol paper for journal publication | On request | ||
| Full protocol text | |||
| Schedule of assessments | |||
| Statistical section with sample size | Approach outlined | Reviewed | Written by a statistician |
| Revision rounds | 1 | 1 | 2 |
The quote for a full protocol depends on the study phase and design, the number of arms, visits and endpoints, whether the ICH M11 template or a sponsor template is required, and how many reviewers will comment. Send the concept through the quote form and a fixed price and schedule are returned.
How the work is checked
- Objectives, endpoints and the statistical section are checked against each other: every objective has an endpoint and every endpoint has an analysis.
- The schedule of assessments is reconciled with the procedures described in the text, visit by visit.
- Eligibility criteria are read by a clinician in the therapeutic area for feasibility and safety.
- The completed SPIRIT 2025 checklist records the page on which each item is addressed.
- Version number and date are carried on every page, with a change log from the first reviewed draft.
Editverse Medical work is aligned with COPE, ICMJE and GPP 2022; institutional and country-specific ethics requirements are followed. Authors keep authorship and accountability.
Not included
Regulatory and ethics submission, case report form design, the investigator's brochure and trial insurance documents are outside this service. Ethics and registration documents are available as a separate pack.
Ordering and payment
The two priced levels can be ordered and paid for by invoice. Alternatively, press Request this service, send the concept, and pay after the first draft is delivered, only if it meets your expectations. Editverse Medical issues an official invoice and receipt for institutional or sponsor accounts. Full protocols and larger scopes are by quote.
Questions about this service
Is the protocol paper the same as the protocol?
No. The protocol paper is a journal article that reports the design of an approved study. It is written from your protocol and follows SPIRIT 2025; the protocol itself is the operational document used at sites.
Do you write to the ICH M11 template?
Yes, for interventional trials intended for regulators, or to a sponsor template if you supply one. SPIRIT 2025 is used alongside either as the completeness checklist.
Can I start with the synopsis and move up later?
Yes. The synopsis is the first section of a full protocol, so the work carries forward into a quoted full protocol.
Who decides the design?
You and your co-investigators. Recommendations are given with reasons, and the choices and accountability stay with the study team.
Part of Clinical study reports. Related: Ethics, Consent and Trial Registration Pack and Sample Size, Power and Study Design.
Order this service
from $400