CLINICAL TRIAL PROTOCOLS

Clinical trial protocols are documents that describe the objectives, design, methodology, statistical considerations and aspects related to the organisation of clinical trials. Trial protocols provide the background and rationale for conducting a study, highlighting specific research questions the study is design to address, and taking into consideration ethical issues.

Our translations leave no room for doubt, inaccuracy, or confusion.

INVESTIGATOR’S BROCHURE (IB)

An Investigator’s Brochure is a collection of clinical and non-clinical data about the investigational products that are the focus of the study. The brochure should provide an ongoing insight into the clinical trial study participants during the duration of the trial.

The purpose of an Investigator’s Brochure is to provide Investigators and other crucial people involved in the trial with enough information to help their understanding of the reasons for and compliance with the key features of a clinical trial protocol including dose, dose frequency, methods of administration and safety monitoring procedures.

INFORMED CONSENT FORM (ICF)

The ICF is used in clinical trials to explain to potential participants the risks and potential benefits of a study, and the rights and responsibilities of the parties involved. It provides a summary of a clinical trial (including its purpose, the treatment procedures and schedules, potential risks and benefits, alternatives to participation, etc.) and explains an individual’s rights as a subject. It is designed to begin the informed consent process, which consists of a dialogue between the subject and the research team.

ETHICS COMMITTEE LETTERS

Ethics committees are tasked with making tough decisions on ethical matters that pertain to research studies, patient care, and the practice of clinicians and care providers.

It goes without saying that the standard of the translation must be closely aligned with the high standards the committee adheres to at all times.

ADVERSE EVENTS REPORTS

Where drugs and medical treatment are concerned, the reporting of adverse reactions – from the mild to the potentially life-threatening – is a role that carries with it a high degree of responsibility.

Our translations of adverse-events reports are conducted by individuals with specialist knowledge and thoroughly checked by our in-house team.

ARTICLES

Medical and healthcare-related articles represent a move away from the rigid structure and concise language of a report or set of instructions, and incorporate analytical thinking, persuasive language, and opinion.

A mediocre or even adequate translation will fail to captivate your readers’ interest and persuade them of your conclusions and methods. This is an area in which Oliver Translations has particular expertise.

DISCHARGE LETTERS

A discharge letter should be brief yet unambiguous, conveying a clear understanding of the patient’s case notes.

Our translations, regardless of the language or subject matter, will capably reflect these requirements.

STANDARD OPERATING PROCEDURES

A standard operating procedure is a set of step-by-step instructions compiled by an organisation to help workers carry out routine operations.

SOPs aim to achieve efficiency, quality output, and uniformity of performance while reducing miscommunication and failure to comply with industry regulations

BACK TRANSLATION

Back-translations are performed when the client requires independent proof that the target language is an accurate translation of the original source language.

This is often an essential requirement for many Clinical Research Organisations. The back-translation is carried out by an independent/blinded medical translator and then subjected to an independent revision process as part of our quality control procedures.