Navigating Clinical Trials: Top-Notch Translation Services
GTS provides top quality clinical trial translation services and certified translation of clinical trial documents in over 80 languages. Our clients are leading pharmaceutical companies, medical device companies and contract research organizations (CRO). Our quality system is certified as compliant with the ISO 17100:2015 quality standard.
Need a price quote to translate an Informed Consent? A clinical study agreement? A clinical protocol? Other clinical study documents? Click here to get an online price quote and delivery time estimate within seconds.
Clinical Trial Translations: Your Partner for Global Success
Customers in the Pharmaceutical, Medical Device and Healthcare industries have come to rely on our team of subject-matter experts for even the most complex translations. Our human resources include linguists with experience in genetics, biochemistry, biotechnology, chemistry, pharmacology, toxicology and most fields of medicine.
We use a stringent quality control process when translating clinical trial documents. We can also provide validation and medical back translation of documents when required by the IRB or Helsinki committee.
Clinical Trials Translation Spanish
GTS provides certified translation services for clinical trial documents in over 80 languages. English to Spanish translation is one of our top language pairs- we translate for many sponsors of clinical trials in the USA which has a large Spanish-speaking population. Customers who have ordered clinical trials translation in Spanish include UCLA David Geffen School of Medicine, NYU Langone Health, Medical College of Wisconsin, Emory University School of Medicine and the Johns Hopkins University School of Medicine.
Exceptional Clinical Trial Translations: We Speak Your Language
The documents we translate include:
- Patient Information Leaflets (PIL)
- Informed Consent Forms (ICF)
- Doctor and Patient Guides
- Case Report Forms (CRF)
- Patient Questionnaires
- Drug Inserts
- Drug Study Labels
- Clinical Protocols
- Regulatory Documents
Clinical Trial Translation Services-Case Studies
Here are some projects that we have done in 2023:
- Translation of clinical protocol and informed consent to Flemish, German and Italian for RevBio, Inc.
- Translation of clinical study documents into Spanish for Cognitive Research Corp.
- Translation of research authorization and informed consent into Spanish for Hartford Healthcare.
- Translation of informed consent forms into Polish, Chinese, Russian and Spanish for NYU Langone Health.
- Translation of informed consent forms into Spanish for Tulane University | School of Medicine.
Clinical Trials Translation-Background Information
Clinical trials are generally considered to be medical or health-related research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. The trial follows a carefully controlled protocol, a study plan that describes what will be done in the study, how it will be conducted, and why each part of the study is necessary.
Clinical trials must be conducted in accordance with the ethical principles stated in the Declaration of Helsinki which are consistent with Good Clinical Practice (GCP) guidelines. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), a unique project bringing together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions, developed guidelines in order to provide clinical trials with a unified standard and provide public assurance that the rights, safety, and wellbeing of trial subjects are protected. The guidelines take into consideration the current good clinical practices (GCP) of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization (WHO).
Bringing a new drug to market is a lengthy and expensive process. Pharmaceutical companies can spend up to 10 years and more, and over $500 million to get a new drug to market. Since more and more clinical research and drug manufacturing are being done in multiple countries and in multiple languages, quality language services can help bring a drug to market faster and can help streamline the clinical trial process.
Medical document translation service may be required at many stages, including clinical research, regulatory submission and review, production and marketing. Moreover, expansion of the EU block into new member countries is also driving increased demand for medical and pharmaceutical translation services.
Translation of Clinical Trial Agreements
A Clinical Trial Agreement (CTA) is a legally binding document that outlines the terms and conditions under which clinical research is conducted. This type of agreement is typically established between entities like pharmaceutical companies, biotechnology firms, medical device companies, and the clinical research organizations (CROs) or healthcare institutions (like hospitals or universities) that conduct the clinical trials.
The CTA covers a wide range of critical aspects, including:
- Scope of the Study: It details the objectives, methodology, duration, and scope of the clinical trial.
- Roles and Responsibilities: The agreement defines the roles and responsibilities of each party involved in the trial, including the sponsor, the investigator, and the institution.
- Regulatory Compliance: It ensures that the trial is conducted in compliance with regulatory requirements, such as those set by the FDA in the United States or the EMA in Europe.
- Patient Safety and Informed Consent: The agreement addresses the procedures for ensuring patient safety, including the process of obtaining informed consent from trial participants.
- Data Management and Confidentiality: The CTA specifies how data collected during the trial will be managed, shared, and protected, and outlines confidentiality obligations.
- Funding and Payment: It includes terms related to the funding of the trial, payment schedules, and reimbursement for expenses.
- Publication Rights: The agreement may set forth conditions regarding the publication of trial results, often to balance the interests of the sponsor and the researchers.
- Intellectual Property Rights: The CTA addresses the ownership of any intellectual property that may arise from the trial.
- Liability and Insurance: The agreement defines liability issues and insurance requirements to cover potential risks associated with the trial.
- Termination Conditions: It outlines the circumstances under which the trial or agreement can be terminated.
Clinical Trial Agreements are crucial for ensuring that clinical trials are conducted ethically, safely, and effectively, with clear understanding and agreement from all parties involved. They play a key role in advancing medical research while protecting the rights and safety of participants and ensuring regulatory compliance.
Quality Clinical Trial Translations: Accuracy Matters
With over 20 years of experience in the field, GTS will deliver the quality that you need to make your clinical trial run smoothly. Get a price quote online now and start your translation project today.