For healthcare & clinical research

Certified translation built for hospitals, clinical research, and medical staff offices.

Verdacert translates patient records, IRB submissions, informed consent forms, foreign medical credentials, and clinical trial documentation under HIPAA-aware handling. Used by hospital systems, contract research organizations, and academic medical centers that need both regulatory compliance and clinical-accuracy reviewer pools.

Built for: Hospital administrators, IRB coordinators, CRO project managers, medical staff credentialing offices

BAA
Business Associate Agreements signed on request
ICH-GCP
Reviewer pool with clinical research backgrounds
100%
ECFMG, CGFNS, and FCVS acceptance on submitted packets
SOC 2
Type II audit in progress; HIPAA-aligned controls
Why this mattersVERTICAL CONTEXT

What healthcare teams actually need from a translation partner.

Healthcare and clinical research generate the most regulated translation work in any vertical. A mistranslated informed consent form is an IRB protocol violation. A misformatted credential package can stall an ECFMG application. A patient record translated by a generalist instead of a clinical reviewer can lead to a medication error. The standard is not 'accurate' — it is 'auditable, attributable, and clinically reviewed.'

Verdacert's healthcare workflow is built on that standard. Every translation involving clinical content is reviewed by a translator with medical-domain experience. We preserve ICD-10 codes, drug brand vs. generic names, dosage units (mg vs. mcg, IU vs. units), lot numbers, and provider seals. The certification statement is drafted to be acceptable to IRBs, the FDA, state medical boards, and ECFMG.

On the operations side, we handle the things hospital systems and CROs actually struggle with: cross-site coordination on multi-language clinical trials, BAA execution, segregated reviewer pools for ICH-GCP work, and version-controlled translations when an IRB amendment lands mid-trial. Document handling is HIPAA-aware: encrypted storage, role-based access, audit logging, and a published subprocessor list.

What we handleRECURRING WORK

The translation work healthcare teams hand to us.

Regulations & standardsWHAT WE ALIGN TO

Rules and standards that govern healthcare translation work.

Every Verdacert translation in this vertical is produced to satisfy the specific regulations below. We cite them explicitly so your compliance team can reconcile our output to your file-review checklist.

45 CFR Part 46 (Common Rule)

Federal policy for protection of human subjects. Informed consent must be in language understandable to the subject — implies certified translation when subjects are not English-proficient.

21 CFR Part 50

FDA protection of human subjects in clinical investigations, including the informed consent requirement at § 50.20 and the short-form documentation rules at § 50.27(b)(2).

ICH-GCP E6(R2/R3)

International Council for Harmonisation Good Clinical Practice guidelines, sections 4.8.6 and 4.8.9 (informed consent) and 8.0 (essential documents).

HIPAA Privacy Rule (45 CFR Parts 160, 164)

Governs handling of protected health information. Verdacert signs BAAs and applies the Privacy Rule's minimum-necessary principle to reviewer access.

ECFMG requirements (Reference Guide)

ECFMG-required documents (Form 186, medical school transcript, diploma) must be submitted in the original language plus a certified English translation prepared by a third party.

21 CFR Part 11

FDA electronic records and signatures rule. Where translated documents are part of the trial master file, audit-trail integrity must be maintained — we deliver versioned PDFs with attributable metadata.

DOCUMENT TYPES

Documents we routinely handle for healthcare accounts

  • Informed consent forms (ICFs) and assent forms
  • IRB submission packages and protocol amendments
  • Patient medical records (history, labs, imaging reports)
  • Vaccination and immunization records
  • Foreign medical school diplomas and transcripts
  • ECFMG, FCVS, CGFNS supporting documents
  • Foreign nursing and allied-health licenses
  • Adverse event narratives and CIOMS forms
  • Case report forms (CRFs) and source documents
  • Foreign clinical guidelines and SOPs
  • Prescription records and pharmacology documentation
  • Insurance correspondence and authorization letters
How we workOPERATIONS

How a healthcare account runs.

How it works03 STEPS · ~5 MIN TO QUOTE

A process you can hand to USCIS without rereading the rules.

Upload, we translate, you submit. Every step is bounded by a real deadline and a named reviewer.

01

Upload your document

Drag & drop a PDF, or photograph the original with your phone. We accept JPG, PNG, HEIC, PDF, and TIFF up to 25 MB.

· Instant page count & quote· Multi-document orders supported
02

We translate & certify

Our translation engine produces a first draft. A vetted native-speaker reviewer with regional expertise edits and signs the certification before release.

· Layout preserved 1:1· Names transliterated to your I-130 spelling
03

Download your USCIS-ready file

You receive a single PDF: original, translation, and the signed certification statement that meets 8 CFR 103.2(b)(3). Notarization and hard copies on request.

· Notarization & apostille add-on· Hard-copy mailing via USPS Priority
FAQFOR HEALTHCARE BUYERS

Healthcare translation: the questions teams ask before signing.

Q.01Does Verdacert sign Business Associate Agreements (BAAs)?
Yes. For any account where we will handle PHI as defined under HIPAA, we sign a BAA before document upload. Our standard BAA addresses minimum-necessary access, breach notification (60 days), subcontractor flow-down, and the HHS Office for Civil Rights inspection language.
Q.02Can a translated informed consent form be submitted to the IRB without back-translation?
Most US-based IRBs accept a forward translation plus a translator certification statement, without requiring back-translation. Some IRBs (typically academic centers with internal SOPs) require independent back-translation; we offer this as a separate review step when required by the IRB's SOP.
Q.03How do you handle protocol amendments mid-trial?
When the IRB-approved English ICF is amended, we re-translate only the changed sections (call-out the diff for the IRB), preserve the prior version in the trial master file, and update the certification statement with the amendment version number and effective date. Subjects already enrolled under the prior version are tracked separately.
Q.04Are your translations accepted by ECFMG?
Yes. ECFMG accepts third-party certified translations for medical school transcripts and diplomas, and explicitly disallows self-translation by the applicant. Our certification statement and packet format meet ECFMG's stated requirements. Applicants typically receive Form 186 verification confirmations without follow-up.
Q.05What about medical terminology accuracy — do reviewers actually have clinical backgrounds?
Healthcare and clinical-trial work is routed to reviewers with documented medical or life-sciences backgrounds (RN, MD, MPH, PharmD, or equivalent). Reviewer credentials are recorded in the certification metadata. We do not route clinical work to general-purpose reviewers.
Q.06Do you preserve ICD codes, drug names, and dosage units exactly?
Yes — these are never localized. ICD-9 / ICD-10 codes, CPT codes, drug brand and generic names, dosage units (mg/mcg/IU/units), lot numbers, manufacturer identifiers, and provider NPI / DEA references are preserved verbatim. Where the source uses a non-US convention (e.g., comma decimal separators in lab values), we annotate the unit conversion in a reviewer note.
Q.07Can you handle multi-language clinical trials across multiple sites?
Yes. We coordinate translation for multi-country trials with a single project manager assigned to your trial, version control aligned with your trial master file structure, and consolidated invoicing. The protocol summary, ICF, and CRFs are kept in sync across all language versions.
Q.08How is patient PII protected during translation?
Documents are stored encrypted at rest (AES-256), transmitted over TLS 1.3, and access is role-based with full audit logging. Reviewers see only the documents on their active matter. Our subprocessor list is published; no clinical work is subcontracted to non-disclosed parties.
A+
BBB accredited business since 2024
20
Languages supported — Arabic, Farsi, Urdu, Pashto, Dari, and more
100%
USCIS acceptance · refund if rejected
Get startedRESPONSE WITHIN ONE BUSINESS DAY

Bring Verdacert into your IRB or credentialing workflow.

Email firms@verdacert.com with the protocol, languages involved, and any sponsor-required SOPs. We'll execute a BAA and have a reviewer pool assigned within one business day.

CONTACT

How to reach us

  • Email · firms@verdacert.com

Include rough monthly volume, primary source languages, and any compliance constraints. We'll tailor the pilot accordingly.

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