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EU CTR submission support

11 vendors · Updated

  1. 1.Freyr SolutionsUnclaimed

    Identifies patient personal data and company confidential information in CSRs, clinical overviews and summaries. Prepares redaction proposal packages, justification and anonymisation reports for Policy 0070 and PRCI, writes plain-language results summaries, and posts protocols and results to registries.

    Offers
    Services

    Strengths

    • Covers Policy 0070 and PRCI redaction packages, registry disclosure and lay summaries
    • Large global footprint; its contact page lists offices and delivery centres in more than 20 countries
    • Says it has 2,500+ in-house regulatory experts and 2,100+ customers

    Watch-outs

    • Its transparency services page does not mention the EU CTR or CTIS by name
    • No specific redaction software is named; the page refers only generally to anonymisation tools
    • InferredTransparency is a small part of a broad regulatory services portfolio; ask for CTIS-specific experience and named team members.
    • InferredWith delivery centres in many countries, ask where the redaction work is done and how quality review is handled.

    Ask them: Can you show recent CTIS redaction work under the revised 2024 transparency rules, and which tools and QC steps you use?

    Sources

  2. 2.ICON plcUnclaimed

    ICON's medical writing group lists redactions, anonymisation, disclosure planning and plain-language summaries (PLS) among its services. It says PLS are written by in-house medical writers and translated by its own language services team. It has also published material on EMA Policy 0070 preparation and on anonymising SDTM datasets for data sharing.

    Size
    About 40,100 employees (Wikipedia, 2025)
    Ownership
    Public (NASDAQ: ICLR)
    Offers
    Services

    Strengths

    • Says it has 400+ staff across medical writing, quality and transparency
    • PLS authoring and translation offered in-house, as one service or combined
    • Covers both document redaction and dataset anonymisation
    • Says it uses AI to help draft CSR plain-language summaries

    Watch-outs

    • Transparency work sits inside a full-service CRO. Check for conflicts if they also run your trials.
    • No dedicated public page on EU CTR / CTIS redaction; the service appears under medical writing.
    • InferredVery large organisation; small, one-off CTIS redaction jobs may get less senior attention than bundled programmes.

    Ask them: Who on your transparency team would prepare our CTIS Part I and Part II redacted documents, and how do you keep CCI redactions consistent with the revised CTIS transparency rules across our trial portfolio?

    Sources

  3. 3.KrystelisUnclaimed

    Redacts personal data and commercially confidential information in EU CTR clinical trial application documents, including RFI responses, and can submit applications in CTIS for sponsors. It also prepares Policy 0070 and Health Canada PRCI anonymisation packages and writes plain-language summaries of protocols and results.

    Offers
    Services

    Strengths

    • Covers redaction, CCI justification, CTIS submission and lay summaries in one service
    • Says its experts have worked on redaction and anonymisation since 2012
    • Says it has trained over 400 sponsor staff on EU CTR and runs a quarterly sponsor forum
    • Has prepared packages under Policy 0043/0070, Health Canada PRCI, PMDA and BfArM requirements

    Watch-outs

    • Its EU CTR page does not mention EMA's June 2024 revised CTIS transparency rules.
    • Public listings give inconsistent locations: its site says UK-headquartered, while its DIA listing gives a Toronto address.
    • InferredNo headcount or project counts are published. Check capacity for large or parallel submissions.

    Ask them: How many redaction specialists would be assigned to our programme, and how would you handle several CTIS submissions with RFI deadlines at the same time?

    Sources

  4. 4.ParexelUnclaimed

    Parexel's medical writing and regulatory consulting staff prepare redaction and anonymisation packages, anonymisation reports, CCI justification tables and plain-language summaries for clients under EU CTR/CTIS and EMA Policy 0070. In a 2023 white paper it says it has submitted Policy 0070 redaction packages to EMA and uses an automated tool for anonymisation.

    Size
    About 21,000 to 24,000 employees (Wikipedia, 2025; figures vary)
    Ownership
    Owned by EQT and Goldman Sachs Asset Management since 2021
    Offers
    Services

    Strengths

    • Says it has direct experience submitting Policy 0070 redaction packages to EMA
    • Covers both EU CTR/CTIS and Policy 0070 work
    • Combines regulatory strategy consulting with medical writing
    • Says an automated tool supports consistent anonymisation

    Watch-outs

    • Transparency work sits inside a full-service CRO. Check for conflicts if they also run your trials.
    • No dedicated public service page on redaction found; details come from a white paper and a job posting.
    • InferredVery large organisation; small, one-off redaction jobs may get less senior attention than bundled programmes.

    Ask them: Which tool do you use to flag personal data and CCI, how is its output checked by people, and can you show a sample CTIS redaction package and justification table?

    Sources

  5. 5.Privacy AnalyticsUnclaimed

    Redacts and anonymises clinical documents for CTIS submissions, EMA Policy 0070 and Health Canada PRCI. Sponsors can use its 'Redaction-as-a-Service' team, which works with its Mirage document anonymisation software, or deploy the software and run redaction in-house.

    Ownership
    Part of IQVIA (acquired by IMS Health, May 2016)
    Offers
    Software and services

    Strengths

    • Has done anonymisation work since EMA Policy 0070 launched in 2015
    • Says it has anonymised more than two million pages of clinical documents (2022)
    • Offers either a managed service or software you run in-house
    • Says it has a team of more than 100 privacy experts

    Watch-outs

    • Owned by IQVIA, which also provides clinical research services. Check for conflicts if IQVIA runs your trials.
    • Its main EU CTR article dates from January 2022, before EMA's revised CTIS transparency rules (June 2024).
    • InferredIts public material focuses on statistical anonymisation. Check how it handles commercially confidential information (CCI) redaction and justification tables under the 2024 rules.

    Ask them: How has your CTIS redaction process changed since the June 2024 revised transparency rules removed deferrals, and how do you handle CCI justifications?

    Sources

  6. 6.ProPharmaUnclaimed

    Its disclosure team redacts CTIS Part I and Part II documents, including national and site-level documents and versions amended after an RFI, and prepares Policy 0070 and PRCI anonymisation packages (justification tables, anonymisation reports). It also writes plain-language summaries and lay protocol synopses, and manages registry postings.

    Size
    Over 2,500 employees (company press release, April 2023)
    Ownership
    Owned by Odyssey Investment Partners (private equity) since 2020
    Offers
    Services

    Strengths

    • Covers CTIS redaction, Policy 0070/PRCI anonymisation, lay summaries and registry posting in one team
    • Says it handles site-specific documents in local languages and runs rapid-response teams for RFI deadlines
    • Says it uses a proprietary redaction platform with AI and automation, plus QC review of documents already redacted

    Watch-outs

    • Owned by private equity firm Odyssey Investment Partners since 2020
    • Disclosure is one service line within a large regulatory and clinical consultancy
    • InferredDisclosure is one of many service lines; ask how big the dedicated transparency team is and whether the same people stay on your studies.
    • InferredThe redaction software is proprietary and offered only through the service, so check how outputs and audit trails can be handed back to you.

    Ask them: How many people work in your dedicated disclosure and redaction team, where are they based, and what turnaround can you commit to for redacting CTIS documents during an RFI response window?

    Sources

  7. 7.Real Life SciencesUnclaimed

    Sells RLS Protect, software for redacting and anonymising clinical documents and datasets with quantitative re-identification risk modelling. It also runs anonymisation and redaction as a managed service using its own staff and tools, covering EU CTR (536/2014) submissions, Policy 0070, PRCI and data sharing.

    Ownership
    Acquired by MediSpend (a Susquehanna Growth Equity portfolio company) in January 2025
    Offers
    Software and services

    Strengths

    • Focused on clinical data anonymisation and redaction rather than general services
    • Software and managed service from the same team, so sponsors can do the work in-house or outsource it
    • Quantitative risk modelling, which it says is the approach Health Canada and EMA expect for PRCI and Policy 0070
    • Says it has processed over 1 million pages and thousands of datasets

    Watch-outs

    • Acquired by MediSpend, a compliance software company backed by Susquehanna Growth Equity, in January 2025
    • Offices listed in the US (Wayne, PA) and the Philippines (Metro Manila); no EU office is listed on its site
    • InferredSince the 2025 acquisition, roadmap and support for the transparency product may be shaped by the parent's wider compliance strategy; ask about product investment plans.
    • InferredQuantitative anonymisation fits Policy 0070 and PRCI; check how the tool handles the lighter, document-level redaction that CTIS now requires.

    Ask them: Since the revised CTIS transparency rules took effect in June 2024, how have you changed RLS Protect and your services for CTIS Part I and Part II documents, and who does the redaction work and where are they based?

    Sources

  8. 8.TrialAssureUnclaimed

    ANONYMIZE does risk-based anonymisation and redaction of documents, datasets and images, including documents published under EU CTR, and reports a re-identification risk score. REGISTRY covers registration, results and documents in CTIS and other registries. LINK AI drafts plain-language summaries, which people review before release.

    Offers
    Software and services

    Strengths

    • Sponsors can license the software, use it with TrialAssure specialists, or outsource the work entirely
    • Says EMA selected ANONYMIZE as an official anonymisation tool (July 2026)
    • Has a European entity in Eindhoven, Netherlands
    • Says 8 of the top 10 clinical development companies use it

    Watch-outs

    • Ownership and headcount are not stated publicly.
    • EMA's selection covers EMA's own redaction of marketing-authorisation dossiers (Policy 0043), not sponsor CTIS submissions.
    • InferredIts plain-language and drafting features are AI-assisted. Ask how human review and QC are documented for CTIS documents.

    Ask them: For a CTIS submission, which parts of redaction and CCI justification does your software do, and which parts your specialists do, and how is each step quality-checked?

    Sources

  9. 9.Trilogy Writing & ConsultingUnclaimed

    Writes the lay summaries of trial results that EU CTR 536/2014 requires sponsors to upload to CTIS, along with protocols, CSRs and other regulatory documents. Its site does not list redaction or anonymisation services.

    Ownership
    Owned by Indegene (via Indegene Ireland) since March 2024
    Offers
    Services

    Strengths

    • Specialist medical writing firm with over 20 years in the field, by its own account
    • Writes lay summaries alongside the CSRs and protocols they draw on

    Watch-outs

    • Acquired by Indegene, a life sciences commercialisation company, in March 2024
    • Its website does not list redaction, anonymisation or CTIS disclosure services
    • InferredBest suited to the lay-summary part of CTR transparency; sponsors needing CTIS redaction will likely need a second vendor.
    • InferredAfter the Indegene acquisition, ask whether work stays with Trilogy's own writers or is shared with the wider Indegene group.

    Ask them: Who writes and reviews the lay summaries, and how do you test that they are readable for the public and meet the CTR template before upload to CTIS?

    Sources

  10. 10.VeristatUnclaimed

    Lists Clinical Disclosure & Transparency among its services. In May 2026 it took over Certara's Regulatory and Medical Writing business (about 220 staff); Certara's transparency team had offered AI-assisted redaction and anonymisation for CTIS submissions, and Certara's transparency pages now redirect to Veristat.

    Ownership
    Private, backed by WindRose Health Investors
    Offers
    Services

    Strengths

    • Took over Certara's regulatory and medical writing team (about 220 staff) in May 2026
    • Certara's transparency team offered AI-assisted CTIS redaction with on-call support

    Watch-outs

    • The Certara business joined Veristat in May 2026; Veristat's site gives few details of its disclosure and transparency service yet.
    • InferredCertara's transparency team appears to have moved with the sale (its pages redirect to Veristat). Confirm which people, tools and partnerships carried over.

    Ask them: Which of Certara's transparency team and tools came over in the sale, and who would deliver our CTIS redaction work?

    Sources

  11. 11.Worldwide Clinical TrialsUnclaimed

    Worldwide says its Transparency & Disclosure team specialises in redaction and anonymisation, builds study-specific personal-data redaction rule tables and advises sponsors on CCI. It says it can provide fully redacted CTIS Part I and Part II packages, Policy 0070 support (risk assessment, anonymisation strategy) and protocol, CSR and manuscript lay summaries.

    Size
    More than 3,500 staff before its 2026 acquisition of Catalyst Clinical Research (company press release, January 2026)
    Ownership
    Majority owned by Kohlberg & Company (deal announced 2023); TJC kept a minority stake
    Offers
    Services

    Strengths

    • Says it can deliver fully redacted CTIS Part I and Part II packages
    • Study-specific PPD redaction rule tables and CCI consultation with sponsors
    • Policy 0070 support including risk assessment and anonymisation strategy
    • Lay summaries for protocols, CSRs and manuscripts

    Watch-outs

    • Transparency work sits inside a full-service CRO. Check for conflicts if they also run your trials.
    • Team size for transparency work is not stated publicly.
    • InferredTransparency is a sub-team of medical writing; capacity for large CTIS or Policy 0070 backlogs is worth confirming.
    • InferredRecent acquisition of Catalyst Clinical Research may bring integration changes in 2026.

    Ask them: How many people are on your Transparency & Disclosure team, and what volume of CTIS redaction packages can you handle in a month without extending timelines?

    Sources

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