eCRF-ePRO DECENTRALIZED CLINICAL TRIALS
DataRiver develops validated (Computer System Validation) Electronic Data Capture (EDC) systems for the management of clinical trials on drugs and medical devices, designed in compliance with international standards, regulations and guidelines for clinical data management . The EDC platforms are designed especially for the management of Decentralized Clinical Trials (DCT) and for the management of retrospective clinical trials involving integration of data collected in other eCRF platforms, EHR, clinical registries and laboratory databases used by clinical research centers.
The systems allow:
- the management of phase I – IV drug studies, observational studies and medical device studies
- the visualization of data and statistics interesting the clinical study and the patient enrollment trend in the sites involved in the experimentation
- the integration of data collected through CRF data sheets with data collected directly from the patient through the management of patient questionnaires and from wearable and medical devices
WHO IS IT FOR?
Pharmaceutical Sector, Biomedical sector, Indipendent Clinical Research
The eCRF and ePRO systems are designed for the management of clinical trials on drugs and medical devices promoted by Pharmaceutical Companies, Biomedical Companies, Hospital,Universities and Research Foundations.
ePRO
The software developed by DataRiver allows the management of questionnaires (such as patient’s daily diary, questionnaires on adverse events, drug toxicity and QoL), surveys, evaluation scales, directly accessible and fillable by patients via smartphone / tablet / PC.
e-CRF Design and Development
DataRiver provides consultancy and support for the design and development of eCRF. The company has gained experience in the management of clinical trials in various therapeutic areas, in particular Oncology, Cardiology, Cardiac Surgery, Hematology, Infectiology, Neurology, Pneumology, Gastroenterology and Rare Diseases.
Data Cleaning, Query, Edit and Validation Check
DataRiver manages data cleaning activities planned in the clinical protocol and query management
Data Management Plan (DMP)
DataRiver provides consultancy and support for writing and reviewing the Data Management Plan (DMP) for phase I-IV, observational and medical device studies.
RELATED CASES
Case studies
RELATED TOOLS
The tools
OpenClinica
Electronic Data Capture System for eCRF management accessible via PC and Tablet
MyHealth eCRF
Electronic Data Capture System for eCRF management accessible via PC and Tablet