Protocol development & scientific writing.
Turn a research idea into a submission-grade protocol, rigorous, defensible, and operable on the ground. Same team, from concept to first-in-human documentation.
The work, made concrete.
Not a service brochure, the actual scope, the actual deliverables, and how it plugs into ECS®.
- Full protocol authorshipRationale, objectives, endpoints, statistical considerations, safety and operational sections, end-to-end.
- Investigator brochure & IMPD sectionsAligned to the protocol and to the regulatory route you're taking.
- Amendment supportFast, defensible amendments, with the operational impact costed before you commit.
- Scientific writingConcept papers, synopses, pre-submission briefing books, protocol summaries for HCP and lay audiences.
Every deliverable has a name on it.
What you receive.
Every engagement lands with named artefacts you can use.
- Regulator-ready protocol (ICH E6(R3), MDR/IVDR or EFSA/FDA framework as applicable)
- Investigator brochure sections
- Study synopsis (technical + plain-language)
- Amendment package with impact assessment
Protocols authored with ECS® in mind translate directly into eCRF, eConsent and monitoring plan, the same source of truth carries the study through execution.
Three moments this service earns its place.
If any of these describe where you are, this is the right entry point.
- Moment 01
You have a strategy and now need to write the protocol.
- Moment 02
An in-house draft needs external, regulatory-hardened review.
- Moment 03
You need a fast, well-argued amendment.
Often engaged together.
Evidence strategy & study design
Map the evidence path, position the product scientifically, and design protocols and endpoints across every domain and product class.
Learn moreRegulatory strategy, submission and market access
Route to approval and route to reimbursement: feasibility, EMA/FDA and MDR/IVDR pathways, submissions, HEOR and payer dossiers.
Learn moreBiostatistics & data management
Sample size, SAP, statistical programming and clean, analysis-ready CDISC data.
Learn moreTalk to the team about this service.
Tell us the study or the question, we'll come back with a scoped answer.