Industries

CROs & IRBs

Clinical Research Organizations (CROs)

Burg is familiar with the special concerns associated with your industry’s projects. For documents like Central Laboratory Manuals, Patient Recruiting Forms, and Informed Consent Forms, we carefully maintain the reading level of the original document. In addition, you may specify target countries for region-specific terminology. We offer unbeatable speed, price, and quality.

Typical Projects Include:

  • Informed Consent Forms (ICFs)
  • Protocols
  • Central Lab Manuals
  • Case Report Forms / eCRFs
  • Instructions for Use (IFUs)
  • Clinical Trial Protocols
  • Adverse Event Reports
  • Patient Reported Outcomes (PROs)
  • Patient Diaries
  • Product Information
  • Dossiers
  • Labeling and Packaging
  • Linguistic Validation

Burg is familiar with Stages I-IV of your industry process. We have handled documents regarding site selection, patient recruitment, data management, clinical operations, regulatory affairs, EDC, and post-market surveillance in a range of medical fields.

Burg works with CROs, sponsors, and sites around the world to translate your study documents to be country-specific. Burg’s responsive Project Managers work with you as consultants, to clarify the specific needs of your projects.

Institutional Review Boards (IRBs)

Burg works closely with IRBs, Independent Ethics Committees (IECs) and Ethical Review Board (ERBs): We are familiar with highly regulated, technical clients.

Talk with a Burg team member to learn how to minimize your costs and accelerate your timeline.

Burg works with required documents for the International Conference on Harmonisation (ICH), including informed consent forms (ICFs), instructions for use (IFUs), Case Report Forms (CRFs), compensation information, and product labels.

Let Burg help you meet your deadlines and keep your translation costs minimized. Our attentive team promptly responds to your questions or quote requests. As you follow FDA, CDER, DHHS OHRP, WHO, and ICH guidelines and regulations, Burg’s experienced team will provide the accurate, timely translations you need.

Typical translations projects include:

  • Informed Consent Forms (ICFs)
  • Assent Forms
  • Protocols and Amendments
  • Instruction Guides
  • Patient Education Materials
  • Investigator’s brochure
  • Advertisements for Subject Recruitment
  • Case Report Forms (CRFs)
  • Investigator Curriculum Vitae (CVs)
  • Labels and Packaging
  • Instructions for Use (IFUs)