The protocol of a clinical trial is a document that must be drawn up in a fully informed manner. It must not “only” accurately describe how the study will be conducted, in dialogue with the clinical facilities where it will be carried out; it will also have to comply with applicable regulatory requirements and, last but not least, be drafted according to sound ethical principles in anticipation of its submission for approval to the relevant ethics committees.
Ancillary to the protocol, but equally important for its conduct and approval, are all the accompanying documents, starting with the Investigator Brochure.
Clariscience is able to support its customers at each of the stages of the path: from dialogue with clinicians during the design of the study, to discussions with the scientific secretariats of the centres of reference, to the drafting of the protocol and ancillary documentation, to dialogue with ethics committees and the competent authorities.
Although Clariscience does not carry out monitoring activities of clinical studies, it can be involved again when the study is finished, both with regard to the analysis of the data and the drafting of the final report. Clariscience’s services in this area are provided by staff with more than a decade of experience in writing protocols and clinical trial reports and in dialogue with national ethics committees.
Popular services include:
- Drafting of Clinical Investigation Protocols
- Preparation of Case Report Forms (CRFs)
- Writing of Clinical Investigation Reports
- Editing of Investigator Brochures
- Preparation of ancillary documentation to be submitted to the relevant ethics committees
