Sponsor and CRO medical writing, regulatory affairs, and study start-up
Lay Summary (EU CTR Annex V) & Recruitment Materials Package
An Annex V-structured lay summary, IRB-ready recruitment materials, and a protocol-mirroring pre-screener, delivered in 48 hours.
The problem
Regulation (EU) No 536/2014 Article 37(4) requires a sponsor to submit trial results within one year of the end of the trial, with a summary written so as to be understandable to laypersons. Annex V prescribes ten mandatory elements.
Since the CTR transition completed on 31 January 2025, CTIS is the sole channel, so every active EU trial sits inside this regime.
It is a hard requirement on a fixed clock, and it usually lands on a medical writer already booked through the quarter, or on the study manager least able to absorb it. The predictable result is documents written at a graduate reading level, submitted late.
What you get
An Annex V-structured lay summary written to plain-language standards, mapped element by element against the ten mandatory items so your regulatory reviewer checks it against the regulation rather than against our formatting.
Draft recruitment materials — a flyer and web copy — that describe the study accurately at an accessible reading level, without overstating benefit or understating burden, built to the constraints of 21 C.F.R. § 312.7 on promotion of investigational drugs.
A six-question pre-screener mirroring your protocol’s key inclusion and exclusion criteria, so the people who contact your sites are the ones worth a screening call.
Turnaround. 48 hours from receipt of the protocol synopsis and results tables.
How it is priced, and why
A fixed fee agreed in advance, per study. It is not tied to how many people contact your sites, how many are screened, or how many enrol — that structure is prohibited on the site side and we do not use it anywhere.
The basis for what we have said
Every figure and regulatory claim on this page is traceable. If you need the underlying source before a procurement conversation, ask and we will send it.
- Article 37(4) requires a layperson-understandable results summary within one year of trial end; Annex V prescribes its content.
- Regulation (EU) No 536/2014, Article 37(4) and Annex V
- CTIS became the sole channel when the CTR transition completed on 31 January 2025.
- EU Clinical Trials Regulation transition, 31 January 2025
- Promotional claims about investigational drugs are restricted.
- 21 C.F.R. § 312.7
What this is not
Corterve does not determine whether anyone is eligible for a study, does not provide medical care, and does not promise that any particular number of people will be screened or enrolled. Those decisions belong to the study team under the protocol. We do not price any part of this work per referral, per candidate, or per enrolment.
Enquire about Lay Summary & Recruitment Materials
Tell us the protocol, indication, or timeline you are working to and we will reply with something specific rather than generic.