Urgent COVID-19 Clinical Trial Translations
As COVID-19 continues to impact countries worldwide, the need for rapid yet highly-accurate clinical trial translation for COVID-19 has increased significantly. For companies leading clinical trials for vaccines, treatments, or new drugs in response to the 2020 pandemic, CSOFT is prepared to offer rapid translation services for COVID-19 clinical trial materials with the shortest possible turnaround.
Learn more about our COVID-19 clinical trial translations.
Enabling Remote Monitoring in Clinical Trials
COVID-19 has disrupted the clinical trial industry with an increasing need for the remote monitoring of patients. This, complemented by the fact that clinical studies are becoming increasingly global, has created an urgent need for the translation and localization of clinical trial documentation. As patients move further away from sites, there is an even more pressing need to develop culturally-sensitive, well-localized content for patient communication in order to build trust and drive patient engagement.
Learn more how CSOFT enables remote clinical trials for life science companies.
Multilingual Clinical Trials
Today, a growing number of clinical trials are conducted globally, with upward of 90 percent of new drugs approved in 2017 undergoing trials and testing outside their primary markets. To meet this trend multilingual clinical trial translation is vital. From contract research organizations (CROs) and sponsors to institutional review boards and clinics, CSOFT’s 10,000+ professional medical translators have the linguistic and regulatory expertise and qualifications to help organizations achieve international compliance through highly-accurate clinical trial documentation translations.
Learn more about our clinical trial translation services.
- Drug Development Process Documentation
- Sample Case Report Form (CRF)
- Informed Consent Form
- Clinical Study Protocol
- Instructions for Use
- Patient Diaries/Reports
- Patient Questionnaires
- Trial Close-out Monitoring Report
Informed Consent Form Translation
Providing clinical trial participants with clear information about the potential risks and benefits of a novel treatment or drug type is essential to avoiding malpractice claims, as well as a firm legal requirement. CSOFT’s informed consent form translation services, a crucial aspect of translations for clinical studies, ensures that patients and their interests are protected and accounted for, regardless of their native language or location of residence.
Trial Master File (TMF) Translations
Trial Master Files are a collection of Essential Documents used by regulatory authorities to determine compliance with Good Clinical Practices (GCP) and clinical trial protocol. TMFs and its digital format, eTMFs, are vital to gaining regulatory compliance when conducting clinical trials. As more clinical trials are conducted in countries where English is not the primary language, highly accurate and timely TMF and eTMF translations are vital to gain regulatory compliance and access new markets.
Learn more about our TMF translations.
At CSOFT, we’re frequently requested to work on a variety of clinical documentation.
Below are some examples of documentation we specialize in:
- Phase 0 to IV
- Pharmacology
- Toxicology
- Informed Consent Forms (ICFs)
- Case Report Forms (CRFs)
- AEs/ARs/SAEs/SARs/SUSARs
- Adverse Drug Reaction (ADRs)
- Package Inserts and Labels
- Insert Leaflets
- Development Safety Update Reports (DSURs)
- IEC/IRB Correspondence
- Clinical Services Agreements
- Protocol & Protocol Synopses
- Investigator’s Brochures (IBs)
- Clinical Study Reports (CSRs)
- Patient-facing Clinical Documents
- Patient Information Sheet (PIS)
- Patient Diaries
- Summary of Product Characteristics (SmPC)
- Instructions for Use (IFUs)
- Scientific Papers
Patient Recruitment Translation
Patient recruitment is a crucial aspect of conducting clinical trials to test the safety and efficacy of new drugs and medical devices. As more and more clinical trials are conducted overseas, using high-quality and accurately translated outreach material is vital to recruiting the right patients to meet clinical trial goals. CSOFT helps sponsors, research sites, and CROs access the patients needed for clinical trials through highly accurate patient recruitment translation.
Learn more about our patient recruitment translations.
End-Point Adjudication
In endpoint adjudication, a blind committee of experts – known as Clinical Event Committees (CEC) or Endpoint Adjudication Committees – independently evaluate clinical events from a clinical trial and adjudicates them with predetermined event classification criteria, reducing potential bias and increasing the validity of trial outcomes. As more and more clinical trials are conducted in countries where English is not the primary language, the need for highly accurate translations of both endpoint adjudication and source case documents with fast turnaround times are vital for successful clinical trials.
Our Methodology
CSOFT guarantees medical translation methodologies that are compliant with regulatory and legal standards, as required by our pharmaceutical clients.
Our translators are native language subject matter experts with field knowledge translating specific content requirements. CSOFT assigns a team of senior medical translators, editors, and in-country reviewers to perform every translation project, with each individually responsible for translation, proofreading, editing, and independent review.
Our years of expertise and experience enables our team to customize operating processes on the basis of analysis on specific project requirements. Whenever necessary extra quality control steps of back translation, linguistic validation, and in-country review (ICR) are performed.
Learn more about our quality assurance process.
