Centaur Clinical Centaur Clinical relies on the commercial strategy in order to propose a clinical strategy and an adapted protocol. Thanks to its experience in clinical operations, its knowledge of site prices and KOLs, Centaur is able to offer services dedicated to the design and drafting of the clinical trial protocol in order to optimise the costs and benefits of the study.
Initially, we will propose to define together the “Study Design”, i.e. the main lines that will lead to the protocol: type of study, duration, number of sites, main and secondary claims, number of subjects, inclusion and exclusion criteria and evaluation criteria. Then we will draft the study protocol which will be submitted to the authorities to start the acceptance process for the start of the study.
This first step is offered to you in the form of a package. As soon as the study design is finalised, we will be able to draw up a precise budget and schedule for the study.
Document in which all the information relating to the product is specified (pre-clinical research phase, scientific publications, adverse effects, etc.).
Centaur Clinical brings you all its expertise in writing this document, taking into account good clinical practice. Authorisations for access to the document must be requested directly from the company owning the product if the clinical study is organised by a doctor or a public institution.
A document that expresses the consent of the volunteer (healthy or ill) to participate in the study under the advice of the doctor who will judge the relevance of his or her participation. The patient is free to interrupt his or her collaboration at any time.
Centaur Clinical has drawn on its experience to draw up this document.
Document required to obtain the CE marking.
It evaluates and analyses the clinical data specific to a medical device to rule on the safety and performance of this device.
Document required by the regulatory authorities. It presents the biostatistical analyses, summarizes the results of the study and gives the conclusions.
The most important element: the biostatistical method will determine the number of patients or volunteers that will be needed to answer your significant hypothesis. Consequently, the biostatistician will define the method to be used, which is essential for the constitution of the protocol.