It does not work without YOUR input
Before a new medicinal product is introduced to the market, safety, efficacy and tolerability have to be tested. YOU have the experience with your product and we have the experience how to bring YOUR product to YOUR planned market.
Non-Interventional Studies are the strength of the LaNova Consulting core competencies. Real Life assessments, so called Real World Evidence (RWE) is needed to understand the impact of a treatment, a medical product or a medical device reflecting the real life conditions of the health care system. Furthermore NIS can be mandatory support to the risk management plan. With post marketing assessments we move from efficacy to effectiveness and document how well a marketed product works and what does it cost.
NIS can be organized as registries, observational studies, cohort studies, Post Authorization Safety Study (PASS) etc.
LaNova Consulting has implemented NIS SOPs and quality management criteria which include submission to an Ethic Committee, in-house review plan, intensive phone monitoring, documentation and at least 10% onsite monitoring with defined Source Data Verification.
Patient Reported Outcomes (PRO) have gained a high degree of acceptance within the last years. PRO concepts measure the health status of a patient, where the patient is the only a source of information. They are complex and their success depends on the willingness of the patient to provide the details of information needed. Therefore the planning and implementation of PRO concepts have to be carefully considered.
PROs are parameters measuring the health status of a patient without interpretation of the treating physician or other persons.
PRO are important to get information about
treatment effects like feeling of depression or pain intensity, which are only known to the patient
treatment satisfaction and treatment effectiveness
systematic data collection of additional use of resources initiated by the patient throughout the therapy (economic evaluations)