Designing a clinical study protocol is truly a team effort. To expedite robust, coordinated protocols we have developed an innovative template-tool for the design of the study protocol that ensures all requirements are addressed to meet regulatory obligations in an efficient and timely manner.
Onorach is able to provide professional protocol-writing services for all phases of drug-related studies and all classes of medical device studies. Onorach can also offer professional protocols specifically related to the biomarker, functional food and cosmetic industries. Specific therapeutic expertise can be accommodated by Onorach’s professional medical writing team, on request.
Onorach is unique in offering a 'patient involvement step' in protocol design to ensure that protocols are workable and achievable for patients as well as clinicians and regulators.
Our aim is to identify, balance, and prioritise what is really necessary in the protocol. In particular, the heart of the clinical study design resides in identifying the Primary and Secondary endpoints to be measured, the anticipated impact on the sites and the participants, and to ensure the statistical robustness of the number of subjects/patients to be recruited.
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