Clinical Quality Solutions is a contract research organization (CRO) providing flexible solutions to successfully plan and complete international clinical investigations to assess device performance and safety in compliance with international regulatory requirements. We offer regulatory, pre-clinical and clinical trial services for medical devices and medical device/drug combinations.

• PROJECT DEFINITION : Project analysis, Regulatory requirements analysis, quality requirements analysis
• TRIAL ADMINISTRATION : Essential documents preparation, Ethical committee and administrative approval flow management
• TRIAL MONITORING : Monitoring plans, Site selection visits, Site initiation visits, Site Monitoring visits, Site close-out visits;
• SAFETY : Risk management
• DATA MANAGEMENT : Data management plan, CRF design, Remote data capture, EDC oracle clinical, Database cleaning, Data format management
  STATISTICS : Statistical analysis plan, Interim analysis, Randomization, Statistical consulting
• REPORTING : Investigational research report, Data monitoring report, Interim safety/efficacy report, Abstract and manuscript
• PROJECT MANAGEMENT

of quality and cost-effective solutions in the field of research has defined our approach to the investigations and project management. The implementation of a risk analysis approach is our "key-element" of successful solutions. From the writing of an investigational plan to the final report all the operational, regulatory and quality aspects meet our client's requirements and satisfaction through "customized solutions".

for any investigation on Medical Device, for profit and no-profit studies. We own a database with all information related to contacts and procedures for ethical committee and administrative approval. In this way we can provide a detailed list of more effective ECS and sites. CRA are selected from our CRA freelance network (www.clintrain.com) where each can access to a route that defines the ability and expertise of each candidate. Our CRA are geographically distributed and this assures an optimal cost/benefit rate. We choose oracle clinical for data management activities. This solution makes use of adobe portable document format to create paper-link CRFs with enterable fileds.
Our experts in quality management are able to audit all the relevant aspects and facilities related to each type of Medical Device in order to ensure that they are fully compliant with regulatory requirements and any other required quality standards. We provide training to ensure that clinical trials are performed to high ethical and quality standard. Detailed training records are provided after each training session, which can be showed to regulatory authorities during inspections to assess the competence of people undertaking investigational trials.