Medical records require authors to have a good grasp of medical terminology and knowledge of terms related to the diagnostic or therapeutic area, as well as being familiar with documentation structure. Drafting medical reports includes preparation of scientific documents, including those related to trials already completed or regulatory documents.
Pure Clinical offers a range of experts with many years of medical industry experience in writing, editing and evaluation of medical records. We are also familiar with the structure of regulatory documents and technical documentation templates for medical devices and in vitro diagnostic medical devices. We are able to walk the manufacturer through the entire trial process, creating the highest quality medical records.
How to draft a Clinical Performance Study Report (CPSR)?
The in vitro diagnostic device performance evaluation report is one of the most important documents representing the device’s efficacy. The CPSR should describe the design, conduct, statistical analysis and results of the clinical efficacy trial. A correctly drafted report should incorporate the appropriate legal regulations and include terminology related to the intended diagnostic area. A strictly specified structure of the document facilitates review and understanding.
Correct preparation of a clinical efficacy trial plan requires in-depth knowledge of the in vitro diagnostic medical device and legal regulations that should be followed while designing the performance evaluation.
The key is to specify the document audience. The author of the performance evaluation plan must consider the audience’s level of expertise. If the plan is addressed to investigators familiar with the terminology and vocabulary typical for a given discipline, the plan should be drafted using industry-specific terms and detailed technical information. A performance evaluation plan addressed to subjects or non-professional users of a diagnostic medical device should take int consideration the audience’s expertise and their capabilities in terms of comprehension of the document. Transparency and legibility of the document are also crucial.
What should be included in the performance evaluation plan?
The trial plan is an important document specifying the rationale, objectives, methodology, risks, proposed result analysis, monitoring and record-keeping related to the clinical efficacy trial. Requirements regarding the site, investigator, and subject inclusion and exclusion criteria should also be defined in a performance evaluation plan.
What is a CRO?
CRO (contract research organization) is a company offering support for the pharmaceutical or medical devices industry in the form of contracted services. Some of the services provided by a CRO include: drafting performance evaluation trial plans, feasibility checks, drafting documentation, clinical trial management or conducting of performance evaluation, as well as monitoring. Lowering the costs related to the trial conduct and market entry facilitation are the aim of any cooperation with a CRO.