The best way to capture real world evidence is to support real world investigators!
Promoting the development of clinical trials means give the best value to research on investigational products. Scientific evidence is made up of many, but small, research studies transformed into high level publications on indexed journals.
Start today by suggesting open medical questions to be answered by your Key Opinion Leaders. Will your product stand the trial of scientific experimental testing?
Given the complex regulatory and managerial landscape for the conduct of clinical trials , Research Group helps sponsors and investigators in design and carry out successful clinical trials on medical devices, food supplement and special medical food.
Observational and quasiexperimental studies are the best choice to let the investigator to contribute to the development and acquisition of new evidence about safety and efficacy of an IMP.
The scientific background and rationale are the most relevant keys to set appropriate study endpoints. Moreover, an appropriate study population is identified through sound selection criteria.
Clinical data capture strategy and management
Data are the pillars which evidence is built on. Digital or traditional data collection have strict rules to follow, for ensuring consistency of proofs, intrinsic validity of the trial and to allow a successful data anlysis.
Design a good and friendly-to-use CRF/eCRF and provide appropriate investigator training are mandatory for a successful trial.
Power your clinical trials and speed up enrollment with Video-assisted Informed Consent
Informed consent is one of the key operations in a clinical trial, due to its paramount importance in either clinical and ethical aspects. Sometimes, administering the consent and delivering a clear and full informative to each of the study subject is time consuming.
Engage the patient and shorten the investigator’s burden with the Video-Assisted Informed Consent!
Regulatory support and clinical data protection
Standards are mandatory. Good Clinical Practice, FDA and local competent authority regulation are strict because of dignity and safety of the study subject is of paramount importance.
GDPR and HIPAA protection requirements ensure that handling of clinical data is carried out in the full respect of property of the information.
Clinical data analytics and statistical reports
Data analysis is a key operation to draw conclusions from the trial. Statistical models for clinical data should be always designed in advance, to optimize timing and resources of data analysis.
Real time analytics can be provided through electronic data capture, and artifical intelligence models can be applied on real world big data.