Clinical writing

The protocol of a clinical trial is a critical document that requires careful and informed preparation. At Clariscience, we are committed to ensuring that every document we prepare not only meets regulatory and ethical standards but also facilitates the success of your clinical trial. Your satisfaction and the integrity of your study are our top priorities. It must not only provide a detailed and accurate description of how the study will be conducted, in collaboration with the clinical facilities where it will take place, but it must also adhere to all applicable regulatory requirements and ethical standards. This ensures a smooth submission and approval process by the relevant ethics committees.
Equally vital to the protocol are the accompanying documents, starting with the Investigator Brochure, which play a significant role in the study’s execution and approval.

At Clariscience, we are dedicated to supporting you at every stage of this journey. Our comprehensive services include: engaging with clinicians during the study design phase to ensure all clinical aspects are meticulously planned; collaborating with the scientific secretariats of reference centers to align on the study’s scientific foundation; drafting the clinical protocol and all necessary ancillary documents, ensuring they meet the highest standards of clarity and compliance; facilitating communication with ethics committees and regulatory authorities to streamline the approval process.
Although we do not conduct clinical study monitoring, Clariscience can step in again after the study is completed to assist with data analysis and the preparation of the final report. Our team boasts over a decade of experience in crafting clinical study protocols and reports and in engaging with national ethics committees.

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