This service aims to ensure that all participants, stakeholders, and regulatory bodies can access accurate and consistent information, regardless of language barriers. Here is an overview of what Actaphase provides:
Translation of Documents
Actaphase undertakes the translation of essential clinical trial documents. – i.e. the research protocol, informed consent forms, patient information sheets, case report forms, questionnaires, and regulatory submissions – into the required target languages.
Quality Assurance
Translations are performed by professional translators with expertise in medical and scientific terminology. Quality checks and reviews are conducted to ensure accurate and contextually-appropriate translations.
Regulatory Compliance
The translated documents adhere to regulatory guidelines and are aligned with the local regulations of the target country. This ensures that translated documents meet the standards required for ethical and regulatory approvals.
Consistency
Actaphase ensures consistency in terminology and wording across all translated documents to prevent confusion and maintain clarity.
Timeliness
Efficient translation services are crucial for timely trial execution. Actaphase prioritizes speed to avoid delays.
Review and Approval
Translated documents are reviewed by relevant stakeholders, such as investigators, ethics committees, and sponsors, to ensure accuracy and suitability for the target audience.
Adaptation to Local Regulations
Actaphase may assist in adapting documents to comply with specific local regulations and requirements, including informed consent laws and data privacy regulations.
Ongoing Support
As the study progresses, Actaphase may provide ongoing translation services for amendments, safety updates, and other study-related documents.